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1.  Outcomes of Xanthogranulomatous cholecystitis in laparoscopic era: A retrospective Cohort study 
Xanthogranulomatous cholecystitis (XGC) is a rare variant of cholecystitis and reported incidence of XGC varies from different geographic region from 0.7% -9%. Most of the clinicians are not aware of the pathology and less evidence is available regarding the optimal treatment of this less common form of cholecystitis in the present era of laparoscopic surgery.
A retrospective cohort study was conducted in a tertiary care university hospital from 1989 to 2009. Histopathologically confirmed XGC study patients (N=27) were compared with non-Xanthogranulomatous cholecystitis (NXGC) control group (N=27). The outcomes variables were operative time, complication rate and laparoscopic to open cholecystectomy conversion rate. The study group (XGC) was further divided in to three sub groups; group I open cholecystectomy (OC), laparoscopic cholecystectomy (LC) and laparoscopic converted to open cholecystectomy (LCO) for comparative analysis to identify the significant variables.
During the study period 6878 underwent cholecystectomy including open cholecystectomy in 2309 and laparoscopic cholecystectomy in 4569 patients. Histopathology confirmed xanthogranulomatous cholecystitis in 30 patients (0.43% of all cholecystectomies) and 27 patients qualified for the inclusion criterion. Gallbladder carcinoma was reported in 100 patients (1.45%) during the study period and no association was found with XGC. The mean age of patients with XGC was 49.8 year (range: 29-79), with male to female ratio of 1:3. The most common clinical features were abdominal pain and tenderness in right hypochondrium. Biliary colic and acute cholecystitis were the most common preoperative diagnosis. Ultrasonogram was performed in all patients and CT scan abdomen in 5 patients. In study population (XGC), 10 were patients in group I, 8 in group II and 9 in group III. Conversion rate from laparoscopy to open was 53 % (n=9), surgical site infection rate of 14.8% (n=4) and common bile duct injury occurred one patient in open cholecystectomy group (3.7%). Statistically significant differences between group I and group II were raised total leukocyte count: 10.6±3.05 vs. 7.05±1.8 (P-Value 0.02) and duration of surgery in minutes: 248.75±165 vs. 109±39.7 (P-Value 0.04). The differences between group III and group II were duration of surgery in minutes: 208.75±58 vs. 109±39.7 (P-Value 0.03) and duration of symptoms in days: 3±1.8 vs. 9.8±8.8 (P-Value 0.04). The mean hospital stay in group I was 9.7 days, group II 5.6 days and in group III 10.5 days. Two patients underwent extended cholecystectomy based on clinical suspicion of carcinoma. No mortality was observed in this study population. Duration of surgery was higher in XGC group as compared to controls (NXGC) (203±129 vs.128±4, p-value=0.008) and no statistically significant difference in incidence proportion of operative complication rate were observed among the group (25.9% vs. 14.8%, p-value=0.25. Laparoscopic surgery was introduced in 1994 and 17 patients underwent laparoscopic cholecystectomy and higher conversion rate from laparoscopic to open cholecystectomy was observed in 17 study group (XGC) as compared to 27 Control group (NXGC) 53%vs.3.3% with P-value of < 0.023.
XGC is a rare entity of cholecystitis and preoperative diagnosis is a challenging task. Difficult dissection was encountered in open as well in laparoscopic cholecystectomy with increased operation time. Laparoscopic cholecystectomy was carried out with high conversion rate to improve the safety of procedure. Per operative clinical suspicion of malignancy was high but no association of XGC was found with gallbladder carcinoma, therefore frozen section is recommended before embarking on radical surgery.
PMCID: PMC3764653  PMID: 24019688
Bile duct injury; laparoscopic cholecystectomy; xanthogranulomatous cholecystitis
2.  Pain Management after Laparoscopic Cholecystectomy-A Randomized Prospective Trial of Low Pressure and Standard Pressure Pneumoperitoneum 
Background: Abdominal pain and shoulder tip pain after laparoscopic cholecystectomy are distressing for the patient. Various causes of this pain are peritoneal stretching and diaphragmatic irritation by high intra-abdominal pressure caused by pneumoperitoneum . We designed a study to compare the post operative pain after laparoscopic cholecystectomy at low pressure (7-8 mm of Hg) and standard pressure technique (12-14 mm of Hg).
Aim : To compare the effect of low pressure and standard pressure pneumoperitoneum in post laparoscopic cholecystectomy pain . Further to study the safety of low pressure pneumoperitoneum in laparoscopic cholecystectomy.
Settings and Design: A prospective randomised double blind study.
Materials and Methods: A prospective randomised double blind study was done in 100 ASA grade I & II patients. They were divided into two groups -50 each. Group A patients underwent laparoscopic cholecystectomy with low pressure pneumoperitoneum (7-8 mm Hg) while group B underwent laparoscopic cholecystectomy with standard pressure pneumoperitoneum (12-13 mm Hg). Both the groups were compared for pain intensity, analgesic requirement and complications.
Statistical Analysis: Demographic data and intraoperative complications were analysed using chi-square test. Frequency of pain, intensity of pain and analgesics consumption was compared by applying ANOVA test.
Results: Post-operative pain score was significantly less in low pressure group as compared to standard pressure group. Number of patients requiring rescue analgesic doses was more in standard pressure group . This was statistically significant. Also total analgesic consumption was more in standard pressure group. There was no difference in intraoperative complications.
Conclusion: This study demonstrates the use of simple expedient of reducing the pressure of pneumoperitoneum to 8 mm results in reduction in both intensity and frequency of post-operative pain and hence early recovery and better outcome.This study also shows that low pressure technique is safe with comparable rate of intraoperative complications.
PMCID: PMC3972609  PMID: 24701492
Standard pressure pneumoperitoneum; Post laparoscopic cholecystectomy pain
3.  Anesthetic implications of laparoscopic surgery. 
Minimally invasive therapy aims to minimize the trauma of any interventional process but still achieve a satisfactory therapeutic result. The development of "critical pathways," rapid mobilization and early feeding have contributed towards the goal of shorter hospital stay. This concept has been extended to include laparoscopic cholecystectomy and hernia repair. Reports have been published confirming the safety of same day discharge for the majority of patients. However, we would caution against overenthusiastic ambulatory laparoscopic cholecystectomy on the rational but unproven assumption that early discharge will lead to occasional delays in diagnosis and management of postoperative complications. Intraoperative complications of laparoscopic surgery are mostly due to traumatic injuries sustained during blind trocar insertion and physiologic changes associated with patient positioning and pneumoperitoneum creation. General anesthesia and controlled ventilation comprise the accepted anesthetic technique to reduce the increase in PaCO2. Investigators have recently documented the cardiorespiratory compromise associated with upper abdominal laparoscopic surgery, and particular emphasis is placed on careful perioperative monitoring of ASA III-IV patients during insufflation. Setting limits on the inflationary pressure is advised in these patients. Anesthesiologists must maintain a high index of suspicion for complications such as gas embolism, extraperitoneal insufflation and surgical emphysema, pneumothorax and pneumomediastinum. Postoperative nausea and vomiting are among the most common and distressing symptoms after laparoscopic surgery. A highly potent and selective 5-HT3 receptor antagonist, ondansetron, has proven to be an effective oral and IV prophylaxis against postoperative emesis in preliminary studies. Opioids remain an important component of the anesthesia technique, although the introduction of newer potent NSAIDs may diminish their use. A preoperative multimodal analgesic regimen involving skin infiltration with local anesthesia. NSAIDs to attenuate peripheral pain and opioids for central pain may reduce postoperative discomfort and expedite patient recovery/discharge. There is no conclusive evidence to demonstrate clinically significant effects of nitrous oxide on surgical conditions during laparoscopic cholecystectomy or on the incidence of postoperative emesis. Laparoscopic cholecystectomy has proven to be a major advance in the treatment of patients with symptomatic gallbladder disease.
PMCID: PMC2578944  PMID: 10604786
4.  Better Treatment Strategies for Patients with Acute Cholecystitis and American Society of Anesthesiologists Classification 3 or Greater 
Yonsei Medical Journal  2010;51(4):540-545.
Laparoscopic cholecystectomy is the best treatment choice for acute cholecystitis. However, it still carries high conversion and mortality rates. The purpose of this study was to find out better treatment strategies for high surgical risk patients with acute cholecystitis.
Materials and Methods
Between January 2002 and June 2008, we performed percutaneous cholecystostomy instead of emergency cholecystectomy in 44 patients with acute cholecystitis and American Society of Anesthesiologists (ASA) classification 3 or greater. This was performed in 31 patients as a bridge procedure before elective cholecystectomy (bridge group) and as a palliative procedure in 11 patients (palliation group).
The mean age of patients was 71.6 years (range 52-86 years). The mean ASA classifications before and after percutaneous cholecystostomy were 3.3 ± 0.5 and 2.5 ± 0.6, respectively, in the bridge group, and 3.6 ± 0.7 and 3.1 ± 1.0, in the palliation group, respectively. Percutaneous cholecystostomy was technically successful in all patients. There were two deaths after percutaneous cholecystostomy in the palliation group due to underlying ischemic heart disease and multiple organ failure. Resumption of oral intake was possible 2.9 ± 1.8 days in the bridge group and 3.9 ± 3.5 days in the palliation group after percutaneous cholecystostomy. We attempted 17 laparoscopic cholecystectomies and experienced one failure due to bile duct injury (success rate: 94.1%). The postoperative course of all cholecystectomy patients was uneventful.
Percutaneous cholecystostomy is an effective bridge procedure before cholecystectomy in patients with acute cholecystitis and ASA classification 3 or greater.
PMCID: PMC2880266  PMID: 20499419
Percutaneous cholecystectomy; acute cholecystitis; American Society of Anesthesiologists classification
5.  Oral premedication with pregabalin or clonidine for hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy: A comparative evaluation 
Saudi Journal of Anaesthesia  2011;5(2):179-184.
Hemodynamic responses of laryngoscopy and laparoscopy should be attenuated by the appropriate premedication, smooth induction, and rapid intubation. The present study evaluated the clinical efficacy of oral premedication with pregabalin or clonidine for hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy.
A total of 180 healthy adult consented patients aged 35 to 52 years with American Society of Anesthesiologist (ASA) physical status I and II of both gender, who met the inclusion criteria for elective laparoscopic cholecystectomy, were randomized to receive placebo Group I, pregabalin (150 mg) Group II, or clonidine (200 μg) Group III, given 75 to 90 minutes before surgery as oral premedication. All groups were compared for preoperative sedation and anxiety level along with changes of heart rate and mean arterial pressure prior to premedication, before induction, after laryngoscopy, pneumoperitoneum, release of carbon dioxide, and extubation. Intraoperative analgesic drug requirement and any postoperative complications were also recorded.
Pregabalin and clonidine proved to have sedative and anxiolytic effects as oral premedicants and decreased the need of intraoperative analgesic drug requirement. Clonidine was superior to pregabalin for attenuation of the hemodynamic responses to laryngoscopy and laparoscopy, but it increased the incidence of intra-and postoperative bradycardia. No significant differences in the parameters of recovery were observed between the groups. None of the premedicated patient has suffered from any postoperative side effects.
Oral premedication with pregabalin 150 mg or clonidine 200 μg causes sedation and anxiolysis with hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy, without prolongation of recovery time and side effects.
PMCID: PMC3139312  PMID: 21804800
Clonidine; hemodynamic response; laparoscopic cholecystectomy; laryngoscopy; pneumoperitoneum; pregabalin
6.  Day-case laparoscopic cholecystectomy 
Saudi Medical Journal  2015;36(1):46-51.
To assess the safety and feasibility of laparoscopic cholecystectomy as a day-case procedure.
All consecutive patients who were admitted to the day-surgery unit for laparoscopic cholecystectomy at the Department of Surgery, King Saud Medical City, Riyadh, Saudi Arabia from July 2009 to June 2013 were considered for this retrospective study. The medical records were reviewed for age, gender, presenting symptoms, laboratory findings, imaging studies, American Society of Anesthesiology (ASA) grade, anesthesia, conversion to open cholecystectomy, complications, the operating surgeons, pain management, nausea, and vomiting, overnight stay, readmission, morbidity, mortality, and outpatient follow up were collected and analyzed.
A total of 487 patients underwent laparoscopic cholecystectomy as a day case (ASA I=316, ASA II=171). Surgery was performed by high surgical trainees (HSTs) (n=417) and consultants (n=70) with conversion to open cholecystectomy in 4 patients. Twenty-two (5%) patients were admitted for overnight stay for different reasons, while 465 (95%) patients were discharged before 8 pm. Two patients (0.4 %) were re-admitted to the hospital due to abdominal pain. Five patients developed umbilical port site infection (1%). A total of 443 patients were satisfied (97%), while 14 (3%) were unsatisfied. There was no mortality or intra-abdominal septic collection.
Day-case laparoscopic cholecystectomy is safe and feasible with optimal patient selection, education, and planned postoperative antiemetic and analgesia management.
PMCID: PMC4362199  PMID: 25630004
7.  The First Experiences of Robotic Single-Site Cholecystectomy in Asia: A Potential Way to Expand Minimally-Invasive Single-Site Surgery? 
Yonsei Medical Journal  2014;56(1):189-195.
Herein, we firstly present the robotic single-site cholecystectomy (RSSC) as performed in Asia and evaluate whether it could overcome the limitations of conventional laparoscopic single-site cholecystectomy.
Materials and Methods
From October 2013 to November 2013, RSSC for benign gallbladder (GB) disease was firstly performed consecutively in five patients. We evaluated these early experiences of RSSC and compared factors including clinicopathologic factors and operative outcomes with our initial cases of single-fulcrum laparoscopic cholecystectomy (SFLC).
Four female patients and one male patient underwent RSSC. Neither open conversion nor bile duct injury or bile spillage was noted during surgery. In comparisons with SFLC, patient-related factors in terms of age, sex, Body Mass Index, diagnosis, and American Society of Anesthesiologist score showed no significant differences between two groups. There were no significant differences in the operative outcomes regarding intraoperative blood loss, bile spillage during operation, postoperative pain scale values, postoperative complications, and hospital stay between the two groups (p<0.05). Actual dissection time (p=0.003) and total operation time (p=0.001) were significantly longer in RSSC than in SFLC. There were no drain insertion or open conversion cases in either group.
RSSC provides a comfortable environment and improved ergonomics to laparoscopic single-site cholecystectomy; however, this technique needs to be modified to allow for more effective intracorporeal movement. As experience and technical innovations continue, RSSC will soon be alternative procedure for well-selected benign GB disease.
PMCID: PMC4276755  PMID: 25510764
Robotic; single-site; single port; cholecystectomy
8.  Single-Site Robotic Cholecystectomy at an Inner-City Academic Center 
We investigate the safety and efficacy of single-site robotic cholecystectomy compared to laparoscopic cholecystectomy at an inner-city academic medical center.
Materials and Methods:
Retrospective analysis comparing single-site robotic to laparoscopic cholecystectomies from August 1, 2013, to January 31, 2015, was conducted. Age, gender, race, body mass index (BMI), total operative time (docking and console time for robotic cases), length of stay, comorbidities, and conversion to open procedures were examined. The χ2 and Student's t test were used for categorical and continuous data, respectively. A P ≤ 0.05 was considered statistically significant.
From August 2013 to January 2015, 70 single-site robotic cholecystectomies and 70 laparoscopic cholecystectomies were performed. Patients were older (mean age, 40.3 years vs 47.6 years; P = .0084), had a higher mean BMI (29.5 vs 32.4 kg/m2; P = .011), and had a higher assigned ASA (American Society of Anesthesiologists) classification (P = .024) in the laparoscopic than in the single-site group. Hypertension was more common in the laparoscopic group (P = .0078). Average docking time was 11.5 (SD 5.7) minutes, and the average console time was 52.8 (SD 22.5) minutes in the single-site group. Total operating time for the laparoscopic and single-site groups was not significantly different (111.5 minutes vs 106.0 minutes; P = .38). There were more conversions to open procedures in the laparoscopic compared to the single-site group (11 vs 1; P = .007). There were no biliary tree injuries and no deaths in either group.
Single-site robotic cholecystectomy is safe to perform in an inner-city academic hospital setting. Surgical resident involvement does not adversely affect outcomes.
PMCID: PMC4487955  PMID: 26175551
Education; Minimally invasive surgery; Outcomes; Robotic surgery
9.  Laparoscopic Cholecystectomy in the Elderly 
To evaluate the outcomes of laparoscopic cholecystectomy in elderly patients at a single institution.
A retrospective chart review was conducted of all patients ≥65 years of age who underwent laparoscopic cholecystectomy over a 5-year period (January 1995 to December 1999). Four-trocar site laparoscopic cholecystectomy using the open Hasson technique were performed in all patients. The demographic data (age, sex), associated comorbidities, American Society of Anesthesiologist's (ASA) score, postoperative morbidity, mortality, and length of stay were recorded for each patient. Statistical analysis was done using Fisher's exact test and chi-square analysis. Statistical significance was defined as P≤0.05.
The patient cohort included 46 patients with a median age of 71 years (range, 65 to 87). Seventeen (37%) patients were ≤70 years of age, and twenty-nine (63%) patients were ≥70 years of age. Twenty-two (48%) patients had ASA scores of ≥3. Patients ≥70 had significantly higher ASA scores. Eighteen patients ≥70 years had ASA ≥3 compared with 4 patients ≤70 with ASA≥3 (P<0.05). Twenty-two patients ≥70 and 8 patients ≤70 required urgent surgery P<0.05). Fifteen (33%) patients presented with acute cholecystitis, and 31 (67%) patients presented with a greater number of chronic symptoms. Four (9%) patients had pancreatitis on presentation, and 6 patients underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP). Two of these 6 patients also underwent sphincterotomy. Urgent surgery was performed in 30 (65%) patients. The mean operative time was 103±37(SD) minutes. One (2%) conversion to open cholecystectomy was required. The mean postoperative stay was 7 days (range, 1 to 46). Fourteen (30%) patients had only a 1-night postoperative stay. Patients ≥70 had significantly longer postoperative stays. Nine patients ≥70 and only 1 patient ≤70 stayed in the hospital for more than 7 days. Postoperative complications were noted in 6 (13%) patients, most of which were chest infections. Five patients ≥70 and only 1 patient ≤70 developed postoperative complications. No mortalities occurred.
Laparoscopic cholecystectomy is safe and feasible in elderly patients. Patients ≥70 years seem to have a longer postoperative stay and slightly more postoperative complications. Age alone should not be a contraindication to laparoscopic cholecystectomy in the elderly patient.
PMCID: PMC3015645  PMID: 16381355
Laparoscopic cholecystectomy; Elderly; Outcomes
10.  Systemic inflammation and immune response after laparotomy vs laparoscopy in patients with acute cholecystitis, complicated by peritonitis 
AIM: To evaluate acute cholecystitis, complicated by peritonitis, acute phase response and immunological status in patients treated by laparoscopic or open approach.
METHODS: From January 2002 to May 2012, we conducted a prospective randomized study on 45 consecutive patients (27 women, 18 men; mean age 58 years). These subjects were taken from a total of 681 patients who were hospitalised presenting similar preoperative findings: acute upper abdominal pain with tenderness, involuntary guarding under the right hypochondrium and/or in the flank; fever higher than 38 °C, leukocytosis greater than 10 × 109/L or both, and ultrasonographic evidence of calculous cholecystitis possibly complicated by peritonitis. These patients had undergone cholecystectomy for acute calculous cholecystitis, complicated by bile peritonitis. Randomly, 23 patients were assigned to laparoscopic cholecystectomy (LC), and 22 patients to open cholecystectomy (OC). Blood samples were collected from all patients before operation and at days 1, 3 and 6 after surgery. Serum bacteraemia, endotoxaemia, white blood cells (WBCs), WBC subpopulations, human leukocyte antigen-DR (HLA-DR), neutrophil elastase, interleukin-1 (IL-1) and IL-6, and C-reactive protein (CRP) were measured at 0, 30, 60, 90, 120 and 180 min, at 4, 6, 12, 24 h, and then daily (8 A.M.) until post-op day 6.
RESULTS: The two groups were comparable in the severity of peritoneal contamination as indicated by the viable bacterial count (open group = 90% of positive cultures vs laparoscopic group = 87%) and endotoxin level (open group = 33.21 ± 6.32 pg/mL vs laparoscopic group = 35.02 ± 7.23 pg/mL). Four subjects in the OC group (18.1%) and 1 subject (4.3%) in the LC group (P < 0.05) developed intra-abdominal abscess. Severe leukocytosis (range 15.8-19.6/mL) was observed only after OC but not after LC, mostly due to an increase in neutrophils (days 1 and 3, P < 0.05). This value returned to the normal range within 3-4 d after LC and 5-7 d after OC. Other WBC types and lymphocyte subpopulations showed no significant variation. On the first day after surgery, a statistically significant difference was observed in HLA-DR expression between LC (13.0 ± 5.2) and OC (6.0 ± 4.2) (P < 0.05). A statistically significant change in plasma elastase concentration was recorded post-operatively at days 1, 3, and 6 in patients from the OC group when compared to the LC group (P < 0.05). In the OC group, the serum levels of IL-1 and IL-6 began to increase considerably from the first to the sixth hour after surgery. In the LC group, the increase of serum IL-1 and IL-6 levels was delayed and the peak values were notably lower than those in the OC group. Significant differences between the groups, for these two cytokines, were observed from the second to the twenty-fourth hour (P < 0.05) after surgery. The mean values of serum CRP in the LC group on post-operative days (1 and 3) were also lower than those in the OC group (P < 0.05). Systemic concentration of endotoxin was higher in the OC group at all intra-operative sampling times, but reached significance only when the gallbladder was removed (OC group = 36.81 ± 6.4 ρg/mL vs LC group = 16.74 ± 4.1 ρg/mL, P < 0.05). One hour after surgery, microbiological analysis of blood cultures detected 7 different bacterial species after laparotomy, and 4 species after laparoscopy (P < 0.05).
CONCLUSION: OC increased the incidence of bacteraemia, endotoxaemia and systemic inflammation compared with LC and caused lower transient immunological defense, leading to enhanced sepsis in the patients examined.
PMCID: PMC3664294  PMID: 23717743
Systemic inflammation; Immune response; Laparoscopy; Cholecystectomy; Bile peritonitis
11.  Acute cholecystitis 
BMJ Clinical Evidence  2008;2008:0411.
Of people admitted to hospital for biliary tract disease, 20% have acute cholecystitis. Up to the age of 50 years, acute calculous cholecystitis is three times more common in women than in men, and about 1.5 times more common in women than in men thereafter. About 95% of people with acute cholecystitis have gallstones. Optimal therapy for acute cholecystitis, based on timing and severity of presentation, remains controversial.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for acute cholecystitis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to December 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
We found 12 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: early cholecystectomy, laparoscopic cholecystectomy, minilaparoscopic cholecystectomy, observation alone, and open cholecystectomy.
Key Points
Acute cholecystitis causes unremitting right upper quadrant pain, anorexia, nausea, vomiting, and fever, and if untreated can lead to perforations, abscess formation, or fistulae. About 95% of people with acute cholecystitis have gallstones.It is thought that blockage of the bile duct by a gallstone or local inflammation can lead to acute cholecystitis, but we don't know whether bacterial infection is also necessary.
Early cholecystectomy within 7 days of onset of symptoms is the treatment of choice for acute cholecystitis. Early surgery reduces the duration of hospital admission compared with delayed surgery, but does not reduce mortality or complications.Up to a quarter of people scheduled for delayed surgery may require urgent operations because of recurrent or worsening symptoms.
Laparoscopic cholecystectomy reduces the duration of admission and may improve intraoperative and postoperative outcomes compared with open cholecystectomy, but increases the risk of bile duct injury. Up to a quarter of people having laparoscopic cholecystectomy may need conversion to open surgery because of risks of complications or uncontrolled bleeding.We don't know whether minilaparoscopic surgery leads to further reductions in duration of admission or improved outcomes compared with laparoscopic surgery.
PMCID: PMC2907986  PMID: 19445789
12.  Inflammation, Insulin Resistance, and Diabetes—Mendelian Randomization Using CRP Haplotypes Points Upstream 
PLoS Medicine  2008;5(8):e155.
Raised C-reactive protein (CRP) is a risk factor for type 2 diabetes. According to the Mendelian randomization method, the association is likely to be causal if genetic variants that affect CRP level are associated with markers of diabetes development and diabetes. Our objective was to examine the nature of the association between CRP phenotype and diabetes development using CRP haplotypes as instrumental variables.
Methods and Findings
We genotyped three tagging SNPs (CRP + 2302G > A; CRP + 1444T > C; CRP + 4899T > G) in the CRP gene and measured serum CRP in 5,274 men and women at mean ages 49 and 61 y (Whitehall II Study). Homeostasis model assessment-insulin resistance (HOMA-IR) and hemoglobin A1c (HbA1c) were measured at age 61 y. Diabetes was ascertained by glucose tolerance test and self-report. Common major haplotypes were strongly associated with serum CRP levels, but unrelated to obesity, blood pressure, and socioeconomic position, which may confound the association between CRP and diabetes risk. Serum CRP was associated with these potential confounding factors. After adjustment for age and sex, baseline serum CRP was associated with incident diabetes (hazard ratio = 1.39 [95% confidence interval 1.29–1.51], HOMA-IR, and HbA1c, but the associations were considerably attenuated on adjustment for potential confounding factors. In contrast, CRP haplotypes were not associated with HOMA-IR or HbA1c (p = 0.52–0.92). The associations of CRP with HOMA-IR and HbA1c were all null when examined using instrumental variables analysis, with genetic variants as the instrument for serum CRP. Instrumental variables estimates differed from the directly observed associations (p = 0.007–0.11). Pooled analysis of CRP haplotypes and diabetes in Whitehall II and Northwick Park Heart Study II produced null findings (p = 0.25–0.88). Analyses based on the Wellcome Trust Case Control Consortium (1,923 diabetes cases, 2,932 controls) using three SNPs in tight linkage disequilibrium with our tagging SNPs also demonstrated null associations.
Observed associations between serum CRP and insulin resistance, glycemia, and diabetes are likely to be noncausal. Inflammation may play a causal role via upstream effectors rather than the downstream marker CRP.
Using a Mendelian randomization approach, Eric Brunner and colleagues show that the associations between serum C-reactive protein and insulin resistance, glycemia, and diabetes are likely to be noncausal.
Editors' Summary
Diabetes—a common, long-term (chronic) disease that causes heart, kidney, nerve, and eye problems and shortens life expectancy—is characterized by high levels of sugar (glucose) in the blood. In people without diabetes, blood sugar levels are controlled by the hormone insulin. Insulin is released by the pancreas after eating and “instructs” insulin-responsive muscle and fat cells to take up the glucose from the bloodstream that is produced by the digestion of food. In the early stages of type 2 diabetes (the commonest type of diabetes), the muscle and fat cells become nonresponsive to insulin (a condition called insulin resistance), and blood sugar levels increase. The pancreas responds by making more insulin—people with insulin resistance have high blood levels of both insulin and glucose. Eventually, however, the insulin-producing cells in the pancreas start to malfunction, insulin secretion decreases, and frank diabetes develops.
Why Was This Study Done?
Globally, about 200 million people have diabetes, but experts believe this number will double by 2030. Ways to prevent or delay the onset of diabetes are, therefore, urgently needed. One major risk factor for insulin resistance and diabetes is being overweight. According to one theory, increased body fat causes mild, chronic tissue inflammation, which leads to insulin resistance. Consistent with this idea, people with higher than normal amounts of the inflammatory protein C-reactive protein (CRP) in their blood have a high risk of developing diabetes. If inflammation does cause diabetes, then drugs that inhibit CRP might prevent diabetes. However, simply measuring CRP and determining whether the people with high levels develop diabetes cannot prove that CRP causes diabetes. Those people with high blood levels of CRP might have other unknown factors in common (confounding factors) that are the real causes of diabetes. In this study, the researchers use “Mendelian randomization” to examine whether increased blood CRP causes diabetes. Some variants of CRP (the gene that encodes CRP) increase the amount of CRP in the blood. Because these variants are inherited randomly, there is no likelihood of confounding factors, and an association between these variants and the development of insulin resistance and diabetes indicates, therefore, that increased CRP levels cause diabetes.
What Did the Researchers Do and Find?
The researchers measured blood CRP levels in more than 5,000 people enrolled in the Whitehall II study, which is investigating factors that affect disease development. They also used the “homeostasis model assessment-insulin resistance” (HOMA-IR) method to estimate insulin sensitivity from blood glucose and insulin measurements, and measured levels of hemoglobin A1c (HbA1c, hemoglobin with sugar attached—a measure of long-term blood sugar control) in these people. Finally, they looked at three “single polynucleotide polymorphisms” (SNPs, single nucleotide changes in a gene's DNA sequence; combinations of SNPs that are inherited as a block are called haplotypes) in CRP in each study participant. Common haplotypes of CRP were related to blood serum CRP levels and, as previously reported, increased blood CRP levels were associated with diabetes and with HOMA-IR and HbA1c values indicative of insulin resistance and poor blood sugar control, respectively. By contrast, CRP haplotypes were not related to HOMA-IR or HbA1c values. Similarly, pooled analysis of CRP haplotypes and diabetes in Whitehall II and another large study on health determinants (the Northwick Park Heart Study II) showed no association between CRP variants and diabetes risk. Finally, data from the Wellcome Trust Case Control Consortium also showed no association between CRP haplotypes and diabetes risk.
What Do These Findings Mean?
Together, these findings suggest that increased blood CRP levels are not responsible for the development of insulin resistance or diabetes, at least in European populations. It may be that there is a causal relationship between CRP levels and diabetes risk in other ethnic populations—further Mendelian randomization studies are needed to discover whether this is the case. For now, though, these findings suggest that drugs targeted against CRP are unlikely to prevent or delay the onset of diabetes. However, they do not discount the possibility that proteins involved earlier in the inflammatory process might cause diabetes and might thus represent good drug targets for diabetes prevention.
Additional Information.
Please access these Web sites via the online version of this summary at
This study is further discussed in a PLoS Medicine Perspective by Bernard Keavney
The MedlinePlus encyclopedia provides information about diabetes and about C-reactive protein (in English and Spanish)
US National Institute of Diabetes and Digestive and Kidney Diseases provides patient information on all aspects of diabetes, including information on insulin resistance (in English and Spanish)
The International Diabetes Federation provides information about diabetes, including information on the global diabetes epidemic
The US Centers for Disease Control and Prevention provides information for the public and professionals on all aspects of diabetes (in English and Spanish)
Wikipedia has a page on Mendelian randomization (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
PMCID: PMC2504484  PMID: 18700811
13.  Outcomes of Laparoscopic Cholecystectomy in Octogenarians 
Laparoscopic cholecystectomy in octogenarians appears to be safe with acceptable morbidity.
Background and Objectives:
Extremely elderly patients usually present with complicated gallstone disease and are less likely to undergo definitive treatment. The purpose of this study was to evaluate the results of laparoscopic cholecystectomy in octogenarians, with an interest in patients presenting initially with complicated gallstone disease and pancreatitis who underwent laparoscopic cholecystectomy during the same hospitalization.
Data for 42 patients ≥80 years who underwent an elective laparoscopic cholecystectomy between January 2007 and August 2011 were retrospectively reviewed. Indications for the procedure were stratified into 2 groups: Outpatients, who were admitted electively to undergo cholecystectomy, and Inpatients, who came to our Emergency Room due to complicated biliary diseases. Data analysis included age, sex, ASA score, conversion to open surgery, time spent under general anesthesia, and length of hospital stay.
Mean age was 83.9 years; 19 (45.2%) were men. Thirteen patients (30.9%) were in the outpatient group, and 13 (30.9%) had a preoperative ASA of 3. Fourteen patients (33.3%) needed ICU. Two patients (4.8%) had their surgery converted. There were 7 (16.7%) postoperative complications, all of them classified as Dindo-Clavien I or II. No differences were noted between groups regarding conversion rates or complications. We had no mortalities in this series. There was no difference in hospital length of stay between the groups.
Laparoscopic cholecystectomy in the extremely elderly is safe, with acceptable morbidity. Patients with complicated gallstone disease seem not to have worse postoperative outcomes once the initial diagnosis is properly treated and would benefit from definitive therapy during the same hospitalization.
PMCID: PMC3481239  PMID: 23477177
Laparoscopic cholecystectomy; Elderly; Gallstone disease; Octogenarians
14.  Cholecystectomy, Conversion and Complications 
HPB Surgery  2000;11(6):373-378.
Background Faced with a difficult laparoscopic cholecystectomy the surgeon may feel that conversion to open operation would risk greater complications because of the laparotomy. Information on the effect of conversion is lacking. The purpose of this study is to measure the complications of laparoscopic cholecystectomy and observe the effect of the conversion rate.
Methods A total of 957 patients were studied. There were three consecutive series of patients; the first undergoing open cholecystectomy (384 patients), the second laparoscopic cholecystectomy with a 5.8% conversion rate (412 patients) and the third laparoscopic cholecystectomy with a 1.3% conversion rate (161 patients). Data was collected prospectively using a continuous audit, and the complication rate compared on an intention to treat basis. In addition a panel of experienced surgeons was asked to score the complications depending on their severity and a composite complication score calculated. Comparison between the 3 groups was then undertaken. Results Open cholecystectomy produced a postoperative complication rate of 6%. Initially this appeared to fall to 3.1% with the introduction of laparoscopic cholecystectomy, but when the complications occurring in the converted patients were included (i.e., on an intention to treat basis) the rate increased to 5.6% in the first group of laparoscopically- treated patients and 3.1% in the second. These differences were not statistically significant. A similar pattern emerged when scoring the severity of the complications as judged by the expert panel. The inclusion of intra-operative complications appears to remove any small advantage for laparoscopic cholecystectomy. The reduction in the conversion rate between the two laparoscopic groups from 5.8% to 1.2% was statistically significant.
Conclusion When considered on an intention to treat basis laparoscopic cholecystectomy offers no advantage over open operation in terms of the frequency or severity of complications. Reducing the frequency of conversion from a laparoscopic to an open procedure also has no significant effect on the complications encountered. We conclude, therefore, that the complication rate is independent of the conversion rate and that the surgeon, when faced with difficulty at laparoscopic cholecystectomy, should not be deterred from converting to open operation for fear of the post-operative consequences.
PMCID: PMC2424007  PMID: 10977115
15.  The comparison of analgesic effects of various administration methods of diclofenac sodium, transdermal, oral and intramuscular, in early postoperative period in laparoscopic cholecystectomy operations 
Objective: The aim of this study was to compare the efficacy of oral, intra muscular and transdermal diclofenac sodium for pain treatment in patients undergoing laparoscopic cholecystectomy, and their effect on postoperative opioid consumption.
Methods: Following informed consent, 90 ASA I-II patients scheduled for laparoscopic cholecystectomy were randomized into three groups. Group PO got oral diclofenac sodium 1 hour before the operation, Group IM 75 mg diclofenac sodium intra muscular and Group TD diclofenac sodium patch 6 hours before the operation. Patients were not premedicated. Routine anaesthesia induction was used. After the operation in post anaesthesia care unit tramadol HCl infusion was delivered by intravenous patient controlled analgesia (iv PCA). Ramsey Sedation Score (RSS), Modified Aldrete’s Score System(MASS) and Visual Analog Scale Pain Score (VAS) was used for postoperative evaluation. Postoperative opioid consumption was recorded.
Results: Demographic characteristics, intraoperative and postoperative hemodynamics of the patients were similar between groups. Postoperative VAS were lower at all time points in Group IM and Group TD than in Group PO. Lowest Postoperative RSS were in Group IM and the highest were in Group PO, and the difference between groups was significant. There was no significant difference in Postoperative MASS between groups. Postoperative tramadol consumption was statistically different between groups. Tramadol consumption in Group IM and Group TD was lower than Group PO. Postoperative nausea and vomiting was not observed. Local complications related to transdermal and intra muscular applications was not reported.
Conclusion: In patients undergoing ambulatory laparoscopic cholecystectomy, a noninvasive application transdermal diclofenac sodium is as effective as intramuscular diclofenac sodium and can be preferred in postoperative pain treatment.
PMCID: PMC3955550  PMID: 24639839
Diclofenac sodium; Laparoscopic cholecystectomy; Tramadol; Postoperative pain; Transdermal
16.  Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes 
BMC Surgery  2006;6:17.
Laparoscopic cholecystectomy is now considered the first option for gallbladder surgery. However, 20% to 30% of cholecystectomies are completed as open operations often on elderly and fragile patients. The external validity of randomised trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy has not been studied. The aim of this study is to analyse characteristics, procedures, and outcomes for all patients who underwent cholecystectomy without being included in such a trial.
Characteristics (age, sex, co-morbidity, and ASA-score), operation time, hospital stay, and mortality were compared for patients who underwent cholecystectomy outside and within a randomised controlled trial comparing mini-laparotomy and laparoscopic cholecystectomy.
During the inclusion period 1719 patients underwent cholecystectomy. 726 patients were randomised and 724 of them completed the trial; 993 patients underwent cholecystectomy outside the trial. The non-randomised patients were older – and had more complications from gallstone disease, higher co-morbidity, and higher ASA – score when compared with trial patients. They were also more likely to undergo acute surgery and they had a longer postoperative hospital stay, with a median 3 versus 2 days (p < 0.001 for all comparisons). Standardised mortality ratio within 90 days of operation was 3.42 (mean) (95% CI 2.17 to 5.13) for non-randomised patients and 1.61 (mean) (95%CI 0.02 to 3.46) for trial patients. For non-randomised patients, operation time did not differ significantly between mini-laparotomy and open cholecystectomy in multivariate analysis. However, the operation for laparoscopic cholecystectomy lasted 20 minutes longer than open cholecystectomy. Hospital stay was significantly shorter for both mini-laparotomy and laparoscopic cholecystectomy compared to open cholecystectomy.
Non-randomised patients were older and more sick than trial patients. The assignment of healthier patients to trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy limits the external validity of conclusions reached in such trials.
PMCID: PMC1769514  PMID: 17190587
17.  Laparoscopic Cholecystectomy as a Day Surgery Procedure: Is it Safe?—An Egyptian Experience 
Major surgery performed as a day surgery procedure is not uncommon. The aim of this study is to evaluate the feasibility of day surgery procedures in laparoscopic cholecystectomy (LC).
Patients and Methods:
A total of 210 patients scheduled for elective LC between 2006 and 2008 were included in our study. The mean age was 40.63 years (range, 25 - 70 years). The indication for surgery was symptomatic cholelithiasis confirmed by ultrasonography without clinical or radiological evidence of acute cholecystitis. All patients were informed about the same-day discharge policy and received the postoperative instruction form on discharge. Preoperative work-up included history taking and physical examination in addition to standard laboratory and radiological tests. Patients above 35 years of age had an ECG done. All patients were examined in the outpatient clinic by a consultant anesthesiologist the night before surgery. Operative time, hospital stay, and complications were recorded. Telephonic feedback, on the morning after surgery was routinely done as an early follow-up.
Out of the total number of patients, 140 patients were ASA (I) and 70 were ASA (II) (40 patients were controlled hypertensives and 30 were controlled diabetics). Conversion rate was 1.4%. The mean hospital stay was 6.7 hours (range, 6 - 8 hours). The mean operative time was 31.2 minutes (range, 20 - 60 minutes). None of the patients required an abdominal drain. No morbidities or mortalities were reported in this series.
LC may be done as a day surgery procedure with optimal patient satisfaction and without complications.
PMCID: PMC3133987  PMID: 21727736
Cholecystectomy; day surgery; laparoscopic
18.  The outcomes of SILS cholecystectomy in comparison with classic four-trocar laparoscopic cholecystectomy 
General approval of laparoscopy as well as persistent urge to minimize operative trauma with still existing difficulties in putting natural orifice transluminal endoscopic surgery (NOTES) into practice have contributed to the introduction of laparoscopic operations through one incision in the umbilicus named single incision laparoscopic surgery (SILS).
The main aim of this study was to assess the benefits to patients of applying SILS cholecystectomy as a method of gallbladder removal based on the comparison with classic four-port laparoscopic cholecystectomy.
Material and methods
Between 18.03.2009 and 09.12.2009, 100 patients were included in the study and they underwent elective gallbladder removal by applying the laparoscopic technique. All patients were divided into two equal groups: qualified for SILS cholecystectomy (group I) and qualified for classic four-trocar laparoscopic cholecystectomy (group II), whose ASA physical status was I and II. BMI was limited to 35 kg/m2. Outcome measures included operative time, intensity of postoperative pain and consumption of painkillers, hospital stay, need for conversion, complications, and cosmetic effects.
Mean operating time in group I was 66 min and in group II 47.2 min. Intensity of pain evaluated by using the visual analogue scale (VAS) 6 h after the operation in group I was 3.49 and in group II 4.53, whereas 24 h after the operation in group I it was 1.18 and in group II 1.55. The painkiller requirement in group I was smaller than in group II. Mean hospital stay after the operation in group I was 1.33 days and in group II 1.96 days. There were 4 conversions in group I and one conversion in group II. Among the complications in group I there were noted 2 cases of right pneumothorax, 1 case of choleperitonitis and 4 complications connected with wound healing. There was one injury of the duodenum and one wound infection in group II.
Single-incision laparoscopic surgery cholecystectomy can be an alternative to classic laparoscopic cholecystectomy, especially with reference to young people with body mass index less than 35 kg/m2, without serious systemic diseases, operated on electively due to benign gallbladder diseases.
PMCID: PMC3557736  PMID: 23362429
single-incision laparoscopic surgery; laparoscopy; cholecystectomy
19.  Efficacy and safety of B-mode ultrasound-guided percutaneous transhepatic gallbladder drainage combined with laparoscopic cholecystectomy for acute cholecystitis in elderly and high-risk patients 
BMC Gastroenterology  2015;15:81.
Standards in treatment of acute cholecystitis (AC) in the elderly and high-risk patients has not been established. Our study evaluated the efficacy and safety of B-mode ultrasound-guided percutaneous transhepatic gallbladder drainage (PTGD) in combination with laparoscopic cholecystectomy (LC) for acute cholecystitis (AC) in elderly and high-risk patients.
Our study enrolled 35 elderly and high-risk AC patients, hospitalized between January 2010 and April 2014 at the Wenzhou People's Hospital. The patients underwent B-mode ultrasound-guided PTGD and LC (PTGD + LC group). As controls, a separate group of 35 elderly and high-risk AC patients who underwent LC alone (LC group) during the same period at the same hospital were randomly selected from a pool of 186 such cases. The volume of bleeding, surgery time, postoperative length of stay, conversion rate to laparotomy and complication rates (bile leakage, bleeding, incisional hernia, incision infection, pulmonary infarction and respiratory failure) were recorded for each patient in the two groups.
All patients in the PTGD + LC group successfully underwent PTGD. In the PTGD + LC group, abdominal pain in patients was relieved and leukocyte count, alkaline phosphatase level, total bilirubin and carbohydrate antigen 19-9 (CA19-9) decreased to normal range, and alanine aminotransferase and aspartate aminotransferase levels improved significantly within 72 h after treatment. All patients in the PTGD + LC group underwent LC within 6–10 weeks after PTGD. Our study revealed that PTGD + LC showed a significantly higher efficacy and safety compared to LC alone in AC treatment, as measured by the following parameters: duration of operation, postoperative length of hospital stay, volume of bleeding, conversion rate to laparotomy and complication rate (operation time of LC: 55.6 ± 23.3 min vs. 91.35 ± 25.1 min; hospitalized period after LC: 3.0 ± 1.3 d vs. 7.0 ± 1.7 d; intraoperative bleeding: 28.7 ± 15.2 ml vs. 60.38 ± 16.4 ml; conversion to laparotomy: 3 cases vs. 10 cases; complication: 3 cases vs. 8 cases; all P < 0.05 ).
Our results suggest that B-mode ultrasound-guided PTGD in combination with LC is superior to LC alone for treatment of AC in elderly and high-risk patients, showing multiple advantages of minimal wounding, accelerated recovery, higher safety and efficacy, and fewer complications.
PMCID: PMC4496925  PMID: 26156691
Percutaneous transhepatic gallbladder drainage; Laparoscopic cholecystectomy; Acute cholecystitis; B-mode ultrasound; Efficacy; Safety
20.  Outcome of Laparoscopic Cholecystectomy at a Secondary Level of Care in Saudi Arabia 
The first option for gallbladder surgery is laparoscopic cholecystectomy. The aim of this study is to analyze the outcomes for all patients who underwent laparoscopic cholecystectomy at a secondary level of care.
Patients and Methods:
Between 2005 and 2008, 968 consecutive laparoscopic cholecystectomies were performed at King Fahad Hospital. We collected and analyzed data including age, gender, body mass index (kg/m2), the American Society of Anesthesiologists (ASA) class, mode of admission (elective or emergency), indication for LC (chronic or acute cholecystitis [AC]), co-morbid disease, previous abdominal surgery, conversion to open cholecystectomy, complications, operation time, and length of postoperative hospital stay.
Nine hundred and sixty-eight patients had laparoscopic cholecystectomy at the center. There were 824 females and 144 males; the age range was 15-64 (mean 32.9± 12.7 years). The operating time was 45 to 180 min (median 85 min); the complication rate was 4.03% (39 patients).
Laparoscopic cholecystectomy could be performed safely in the majority of patients with cholelithiasis, by an experienced surgical team at a secondary level of care.
PMCID: PMC3099081  PMID: 21196653
Complications; laparoscopic cholecystectomy; morbidity
21.  Premedication with clonidine versus fentanyl for intraoperative hemodynamic stability and recovery outcome during laparoscopic cholecystectomy under general anesthesia 
Laparoscopic cholecystectomy under general anesthesia induced intraoperative hemodynamic responses which should be attenuated by appropriate premedication. The present study was aimed to compare the clinical efficacy of clonidine and fentanyl premedication during laparoscopic cholecystectomy for attenuation of hemodynamic responses with postoperative recovery outcome.
Subjects and Methods:
In this prospective randomized double blind study 64 adult consented patients of either sex with ASA I and II, scheduled for elective laparoscopic cholecystectomy under general anesthesia and met the inclusion criteria, were allocated into two groups of 32 patients. Group C patients have received intravenous clonidine 1μg kg-1 and Group F patients have received intravenous fentanyl 2μg kg-1 5 min before induction. Anesthetic and surgical techniques were standardized. All patients were assessed for intraoperative hemodynamic changes at specific time and postoperative recovery outcome.
Premedication with clonidine or fentanyl has attenuated the hemodynamic responses of laryngoscopy and laparoscopy. Clonidine was superior to fentanyl for intraoperative hemodynamic stability. No significant differences in the postoperative recovery outcome were observed between the groups. Nausea, vomiting, shivering and respiratory depression were comparable between groups.
Premedication with clonidine or fentanyl has effectively attenuated the intraoperative hemodynamic responses of laparoscopic cholecystectomy.
PMCID: PMC4173492  PMID: 25885716
Clonidine; fentanyl; hemodynamic response; laparoscopic cholecystectomy; laryngoscopy; pneumoperitoneum
22.  Percutaneous cholecystostomy in acute cholecystitis; a retrospective analysis of a large series of 104 patients 
BMC Surgery  2015;15:17.
The purpose of this study was to evaluate the clinical course and possible benefit of a percutaneous cholecystostomy in patients with acute cholecystitis.
Retrospective study of 104 patients with severe cholecystitis or cholecystitis not responding to antibiotic therapy treated with percutaneous drainage of the gall bladder (PC) during the period 2007 – 2013. Primary outcome was relief of cholecystitis, complications following the procedure and need for later cholecystectomy.
There were 57 men and 47 women with a median age of 73,5 years (range 22 – 96). 43% of the patients were ASA III or IV and 91% had cholecystitis Grade 2 or 3. About 60% of the patients had severe comorbidity (cardiovascular disease or active cancer). Drain insertion was successful in all but one patient and complications were mild, apart from two patients that needed percutaneous drainage of intraabdominal fluid collection due to bile leakage. The drain was left in place for 1 – 75 days (median 6,5). When evaluated clinically and by blood tests (CRP and white blood cell counts) we found resolution of symptoms in 101 patients (97,2%), whereas 2 patients had no obvious effect of drainage. Four patients died within 30 days, no deaths were related to the drainage procedure. Follow-up after drainage was median 12 months (range 0 – 78). During that time cholecystectomy was performed in 30 patients and 24 patients had died. Following cholecystectomy, two had died, both from cancer and more than one year after the operation.
Patients with acute cholecystitis were promptly relieved from their symptoms following PC. There were only minor complications following the procedure and only about 30% of the patients had a later cholecystectomy.
PMCID: PMC4357156  PMID: 25872885
Cholecystitis; Cholecystostomy; Percutaneous; Complications
23.  Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: A Prospective, Randomized Study 
International Surgery  2014;99(1):56-61.
We aimed to compare the clinical outcome and cost of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Sixty patients with acute cholecystitis were randomized into early (within 24 hours of admission) or delayed (after 6–8 weeks of conservative treatment) laparoscopic cholecystectomy groups. There was no significant difference between study groups in terms of operation time and rates for conversion to open cholecystectomy. On the other hand, total hospital stay was longer (5.2 ± 1.40 versus 7.8 ± 1.65 days; P = 0.04) and total costs were higher (2500.97 ± 755.265 versus 3713.47 ± 517.331 Turkish Lira; P = 0.03) in the delayed laparoscopic cholecystectomy group. Intraoperative and postoperative complications were recorded in 8 patients in the early laparoscopic cholecystectomy group, whereas no complications occurred in the delayed laparoscopic cholecystectomy group (P = 0.002). Despite intraoperative and postoperative complications being associated more with early laparoscopic cholecystectomy compared with delayed intervention, early laparoscopic cholecystectomy should be preferred for treatment of acute cholecystitis because of its advantages of shorter hospital stay and lower cost.
PMCID: PMC3897343  PMID: 24444271
Acute cholecystitis; Laparoscopic cholecystectomy; Outcome assessment; Cost and cost analysis
24.  Tolerability and feasibility of eptifibatide in acute coronary syndrome in patients at high risk for cardiovascular disease: A retrospective analysis* 
Despite the beneficial effects of glycoprotein (GP) IIb/IIIa antagonists in patients with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), GP IIb/IIIa antagonists are rarely administered in general internal medicine wards in Israel, where most patients with UA/ NSTEMI are admitted, due to lack of adequate monitoring and safety concerns.
The aims of this study were to compare the prevalence of bleeding complications in patients with UA/NSTEMI receiving combination treatment with eptifibatide (a GP IIb/IIIa antagonist), the low-molecular-weight heparin enoxaparin, and acetylsalicylic acid (ASA) versus that in patients receiving enoxaparin and ASA in internal medicine wards in Israel, and to identify risk factors for bleeding complications.
This retrospective analysis included information from the database at Rambam Medical Center, Haifa, Israel. The database provided information from 4 of the 5 wards (the ward from which data were unavailable did not routinely use eptifibatide). Data were included from patients aged ≥l.8 years who were admitted to the center with a diagnosis of UA/NSTEMI, were at high risk for death and/or nonfatal ischemic events based on American College of Cardiology/American Heart Association guidelines, were to undergo coronary intervention, and who had a Thrombosis in Myocardial Infarction risk score ≥3 (moderate to high risk). Patients in the eptifibatide group received eptifibatide IV (180-μg/kg bolus followed by a continuous infusion of 2 μg/kg · min up to 72 hours), enoxaparin SC (2 mg/kg · d), and ASA (100 mg/d). Patients in the control group received enoxaparin SC (2 mg/kg - d up to 96 hours) and ASA (100 mg/d). The prevalence of bleeding events was assessed using data up to 24 hours after the end of study drug administration. Major bleeding was defined as life-threatening bleeding at any site, intracranial hemorrhage, or bleeding accompanied by a decrease in plasma hemoglobin concentration of 5 g/dL or more. Otherwise, bleeding was considered minor. The risk for bleeding events was assessed using multivariate regression analysis.
Data from 105 patients (64 men, 41 women) were included in the analysis. In the eptifibatide and control groups, the mean (SD) ages were 68.7 (11.1) and 74.8 (11.0) years, respectively. These characteristics were statistically similar between the 2 groups. The rates of major bleeding were similar between the eptifibatide and control groups (2 [3.8%] vs 0 patients). The rate of minor bleeding was significantly higher in the eptifibatide group compared with that in controls (11 [21.2%] vs 4 [7.5%] patients; P = 0.03). The incidence of thrombocytopenia was statistically similar between the eptifibatide and control groups (0 vs 2 [3.8%] patients). The risk for bleeding was found to be associated with eptifibatide use (odds ratio, 4.8; 95% CI, 1.29–17.80), whereas an association with treatment was not found in the control group.
The results of this retrospective analysis suggest that the risk for bleeding complications is higher with combination treatment with eptifibatide, enoxaparin, and ASA compared with that with enoxaparin and ASA in high-risk patients with UA/NSTEMI admitted to internal medicine wards in Israel.
PMCID: PMC3965992  PMID: 24678072
GP IIb/IIIa antagonists; eptifibatide; unstable angina and non-ST-segment elevation myocardial infarction; bleeding; Thrombosis in Myocardial Infarction risk score; aspirin; low-molecular-weight heparin; enoxaparin; anti-coagulation; combination
25.  Laparoscopic Cholecystectomy Under Spinal Anaesthesia vs. General Anaesthesia: A Prospective Randomised Study 
Introduction: Laparoscopic cholecystectomy (LC) is conventionally performed under general anaesthesia (GA) in our institution. There are multiple studies which have found spinal anaesthesia as a safe alternative. We have conducted this study of LC, performed under spinal anesthesia to assess its safety and feasibility in comparison with GA.
Materials and Methods: Fifty patients with symptomatic gallstone disease and American Society of Anesthesiologists status I or II were randomised to have LC under spinal (n = 25) or general (n = 25) anesthesia. Intraoperative vitals, postoperative pain, complications, recovery, and surgeon satisfaction were compared between the 2 groups.
Results: In the SA group six patients (24%) complained of shoulder pain, two patients required conversion to GA (8%) as the pain did not subside with Fentanyl. None of the patients in the SA group had immediate postoperative pain at operated site. Only two (8%) patients had pain score of 4 at the operative site within eight hours requiring rescue analgesic. One patient had nausea but no vomiting (4%). All the patients (100%) in the GA group had pain at operated site immediately after surgery and their pain score ranged from 4-7, all patients received rescue analgesic before shifting to the ward. In the first 24h tramadol required as rescue in the GA group was 82±24 mg which was significantly higher than the SA group requiring only 30±33.16 mg. Although, the GA group had more patients experiencing postoperative nausea & vomiting it was not statistically significant.
Conclusion: SA as the sole anaesthesia technique is feasible, safe and cost effective for elective LC.
PMCID: PMC4190755  PMID: 25302232
Cholecystectomy; Gallstone disease; Laparoscopic cholecys-tectomy; Laparoscopy; Regional anesthesia; Spinal anesthesia

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