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1.  TGFBR1 Signaling and Breast Cancer 
Over the past decade mutations discovered in genes such as BRCA1, BRCA2, TP53 and PTEN, have emerged as high-penetrance susceptibility genes and are clinically relevant for determination of breast cancer risk. Genetic counseling and subsequent screening for mutations and gene rearrangement has improved patient outcome through early detection and prophylactic interventions in patients with familial breast cancer syndromes. However, these high-penetrance genes only account for a small fraction of the hereditary linked breast cancers. It is currently believed that low-penetrance susceptibility alleles and/or environmental factors may play an important role in the remaining cases. TGFBR1*6A (*6A) is a common hypomorphic variant of the type I TGF-β receptor gene (TGFBR1) that has been associated with risk for several forms of cancer, in particular breast cancer. Several epidemiological studies have suggested that patients who carry the *6A allele have an increased risk of breast cancer. Furthermore, functional analysis suggests that this mutation alters TGF-β signaling and promotes tumorigenesis. Although a decade of research has provided basic information in regards to the prevalence of this mutation in several cancer types and populations the molecular underpinning of its functional effects are poorly understood. A better understanding of the molecular mechanism of TGFBR1 signaling in breast cancer may have an impact on breast cancer risk assessment and breast cancer prevention.
PMCID: PMC4753062  PMID: 21461994
TGFBR1; Breast cancer; TGF-β; Cancer genetics; Low-penetrance susceptibility alleles; BRCA1/2; TP53; PTEN; CHEK2; Li Fraumeni syndrome; Cowden’s disease; Hereditary breast and ovarian syndrome
2.  Failure of available scoring systems to predict ongoing infection in patients with abdominal sepsis after their initial emergency laparotomy 
BMC Surgery  2011;11:38.
To examine commonly used scoring systems, designed to predict overall outcome in critically ill patients, for their ability to select patients with an abdominal sepsis that have ongoing infection needing relaparotomy.
Data from a RCT comparing two surgical strategies was used. The study population consisted of 221 patients at risk for ongoing abdominal infection. The following scoring systems were evaluated with logistic regression analysis for their ability to select patients requiring a relaparotomy: APACHE-II score, SAPS-II, Mannheim Peritonitis Index (MPI), MODS, SOFA score, and the acute part of the APACHE-II score (APS).
The proportion of patients requiring a relaparotomy was 32% (71/221). Only 2 scores had a discriminatory ability in identifying patients with ongoing infection needing relaparotomy above chance: the APS on day 1 (AUC 0.61; 95%CI 0.52-0.69) and the SOFA score on day 2 (AUC 0.60; 95%CI 0.52-0.69). However, to correctly identify 90% of all patients needing a relaparotomy would require such a low cut-off value that around 80% of all patients identified by these scoring systems would have negative findings at relaparotomy.
None of the widely-used scoring systems to predict overall outcome in critically ill patients are of clinical value for the identification of patients with ongoing infection needing relaparotomy. There is a need to develop more specific tools to assist physicians in their daily monitoring and selection of these patients after the initial emergency laparotomy.
Trial registration number
PMCID: PMC3268736  PMID: 22196238
3.  Bovine pericardium retail preserved in glutaraldehyde and used as a vascular patch 
BMC Surgery  2011;11:37.
In this study we evaluated the performance of bovine pericardium preserved in glutaraldehyde used as a vascular patch.
Fourteen young pigs, six females and eight males, weighting 10.3 - 18.4 kg were used in our study. We implanted three remnants in each pig, two in the abdominal aorta and one was juxtaposed to the peritoneum. The smooth face (SF) and rough face (RF) of each remnant were implanted turned to the vessel inner portion and one remnant was juxtaposed to the peritoneum. The animals were sacrificed in 4.5 - 8 months after surgery (75 - 109 kg). The remnants were assessed for aorta wall, fibroses formation in inner apposition and calcification related to the face turned to the vessel inner portion.
The rough face showed a lower dilatation level compared to the face implanted in adjacent aorta. There was no difference between intensity and/or incidence of graft calcification when the superficies were compared. The bovine pericardium preserved in glutaraldehyde did not show alterations in its structure when implanted with different faces turned to the inner portion of vessel.
When turned to the inner portion of the vessel, the rough face of the remnant presented a lower dilatation in relation to the adjacent aorta and a better quality of endothelium layer and did not show a difference between intensity and/or incidence of graft calcification.
PMCID: PMC3258210  PMID: 22192162
4.  Tension of knotted surgical sutures shows tissue specific rapid loss in a rodent model 
BMC Surgery  2011;11:36.
Every surgical suture compresses the enclosed tissue with a tension that depends from the knotting force and the resistance of the tissue. The aim of this study was to identify the dynamic change of applied suture tension with regard to the tissue specific cutting reaction.
In rabbits we placed single polypropylene sutures (3/0) in skin, muscle, liver, stomach and small intestine. Six measurements for each single organ were determined by tension sensors for 60 minutes. We collected tissue specimens to analyse the connective tissue stability by measuring the collagen/protein content.
We identified three phases in the process of suture loosening. The initial rapid loss of the first phase lasts only one minute. It can be regarded as cutting through damage of the tissue. The percentage of lost tension is closely related to the collagen content of the tissue (r = -0.424; p = 0.016). The second phase is characterized by a slower decrease of suture tension, reflecting a tissue specific plastic deformation. Phase 3 is characterized by a plateau representing the remaining structural stability of the tissue. The ratio of remaining tension to initial tension of phase 1 is closely related to the collagen content of the tissue (r = 0.392; p = 0.026).
Knotted non-elastic monofilament sutures rapidly loose tension. The initial phase of high tension may be narrowed by reduction of the surgeons' initial force of the sutures' elasticity to those of the tissue. Further studies have to confirm, whether reduced tissue compression and less local damage permits improved wound healing.
PMCID: PMC3275509  PMID: 22188826
suture tension; cutting reaction; collagen; suture material; polypropylene; tension sensor
5.  Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol 
BMC Surgery  2011;11:35.
Peritoneal dialysis (PD) is an effective treatment for end-stage renal disease. It allows patients more freedom to perform daily activities compared to haemodialysis. Key to successful PD is the presence of a well-functioning dialysis catheter. Several complications, such as in- and outflow obstruction, peritonitis, exit-site infections, leakage and migration, can lead to catheter removal and loss of peritoneal access. Currently, different surgical techniques are in practice for PD-catheter placement. The type of insertion technique used may greatly influence the occurrence of complications. In the literature, up to 35% catheter failure has been described when using the open technique and only 13% for the laparoscopic technique. However, a well-designed randomized controlled trial is lacking.
The LOCI-trial is a multi-center randomized controlled, single-blind trial (pilot). The study compares the laparoscopic with the open technique for PD catheter insertion. The primary objective is to determine the optimum placement technique in order to minimize the incidence of catheter malfunction at 6 weeks postoperatively. Secondary objectives are to determine the best approach to optimize catheter function and to study the quality of life at 6 months postoperatively comparing the two operative techniques.
This study will generate evidence on any benefits of laparoscopic versus open PD catheter insertion.
Trial registration
Dutch Trial Register NTR2878
PMCID: PMC3266194  PMID: 22185091
6.  The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery 
BMC Surgery  2011;11:34.
The CARTS study is a multicenter feasibility study, investigating the role of rectum saving surgery for distal rectal cancer.
Patients with a clinical T1-3 N0 M0 rectal adenocarcinoma below 10 cm from the anal verge will receive neoadjuvant chemoradiation therapy (25 fractions of 2 Gy with concurrent capecitabine). Transanal Endoscopic Microsurgery (TEM) will be performed 8 - 10 weeks after the end of the preoperative treatment depending on the clinical response.
Primary objective is to determine the number of patients with a (near) complete pathological response after chemoradiation therapy and TEM. Secondary objectives are the local recurrence rate and quality of life after this combined therapeutic modality. A three-step analysis will be performed after 20, 33 and 55 patients to ensure the feasibility of this treatment protocol.
The CARTS-study is one of the first prospective multicentre trials to investigate the role of a rectum saving treatment modality using chemoradiation therapy and local excision. The CARTS study is registered at (NCT01273051)
PMCID: PMC3295682  PMID: 22171697
7.  Laparoscopic gastric pouch and remnant resection: a novel approach to refractory anastomotic ulcers after Roux-en-Y Gastric Bypass: Case report 
BMC Surgery  2011;11:33.
Anastomotic or marginal ulcers occur in 0.6 to 16% of patients after laparoscopic Roux-en-Y-Gastric Bypass. Initial therapy aims at eliminating known risk factors including smoking, Helicobacter pylori infection, use of non-steroidal anti-inflammatory drugs and inhibition of gastric acid secretion. While this approach is successful in 68 to 88% of the cases, up to one third of patients need a subsequent surgical revision. However, marginal ulcers still recur in up to 10% of cases after revisional surgery, thus constituting a serious challenge for bariatric surgeons.
Case presentation
We herein report a case of an insidious marginal ulcer refractory to both medical therapy with high-dosed proton pump inhibitors and sucralfate as well as surgical therapy consisting of the lengthening of a short alimentary limb and later resection of the gastroenterostomy and construction of a new tension-free anastomosis. Only after gastrectomy by laparoscopic en-bloc resection of the gastrojejunostomy, the gastric pouch and resection of the gastric remnant with reconstruction by esophagojejunostomy the patient remained free of symptoms.
By laparoscopic resection of the entire gastric pouch and the gastric remnant the risk to leave a suboptimally vascularised or even ischemic pouch in situ was avoided. The esophagojejunostomy was then created in healthy, good vascularised tissue. In our case this novel approach was effective in the management of a refractory anastomotic ulcer and might represent a rescue option when simple revision of the gastrojejunostomy fails.
PMCID: PMC3247190  PMID: 22136170
Roux-en-Y-Gastric Bypass; bariatric surgery; anastomotic ulcer; marginal ulcer; obesity
8.  Acute effects of remote ischemic preconditioning on cutaneous microcirculation - a controlled prospective cohort study 
BMC Surgery  2011;11:32.
Therapeutic strategies aiming to reduce ischemia/reperfusion injury by conditioning tissue tolerance against ischemia appear attractive not only from a scientific perspective, but also in clinics. Although previous studies indicate that remote ischemic intermittent preconditioning (RIPC) is a systemic phenomenon, only a few studies have focused on the elucidation of its mechanisms of action especially in the clinical setting. Therefore, the aim of this study is to evaluate the acute microcirculatory effects of remote ischemic preconditioning on a distinct cutaneous location at the lower extremity which is typically used as a harvesting site for free flap reconstructive surgery in a human in-vivo setting.
Microcirculatory data of 27 healthy subjects (25 males, age 24 ± 4 years, BMI 23.3) were evaluated continuously at the anterolateral aspect of the left thigh during RIPC using combined Laser-Doppler and photospectrometry (Oxygen-to-see, Lea Medizintechnik, Germany). After baseline microcirculatory measurement, remote ischemia was induced using a tourniquet on the contralateral upper arm for three cycles of 5 min.
After RIPC, tissue oxygen saturation and capillary blood flow increased up to 29% and 35% during the third reperfusion phase versus baseline measurement, respectively (both p = 0.001). Postcapillary venous filling pressure decreased statistically significant by 16% during second reperfusion phase (p = 0.028).
Remote intermittent ischemic preconditioning affects cutaneous tissue oxygen saturation, arterial capillary blood flow and postcapillary venous filling pressure at a remote cutaneous location of the lower extremity. To what extent remote preconditioning might ameliorate reperfusion injury in soft tissue trauma or free flap transplantation further clinical trials have to evaluate.
Trial registration NCT01235286
PMCID: PMC3231986  PMID: 22111972
Remote ischemic preconditioning; cutaneous microcirculation; free flap; soft tissue
9.  Auto-aggressive metallic mercury injection around the knee joint: a case report 
BMC Surgery  2011;11:31.
Accidental or intentional subcutaneous and/or intramuscular injection of metallic mercury is an uncommon form of poisoning. Although it does not carry the same risk as mercury vapour inhalation, it may cause destructive early and late reactions.
Case Presentation
Herein we present the case of a 29-year-old male patient who developed an obsessive-compulsive disorder causing auto-aggressive behaviour with injection of elemental mercury and several other foreign bodies into the soft tissues around the left knee about 15 years before initial presentation. For clinical examination X-rays and a CT-scan of the affected area were performed. Furthermore, blood was taken to determine the mercury concentration in the blood, which showed a concentration 17-fold higher than recommended. As a consequence, the mercury depots and several foreign bodies were resected marginally.
Blood levels of mercury will decrease rapidly following surgery, especially in combination with chelating therapy. In case of subcutaneous and intramuscular injection of metallic mercury we recommend marginal or wide excision of all contaminated tissue to prevent migration of mercury and chronic inflammation. Nevertheless, prolonged clinical and biochemical monitoring should be performed for several years to screen for chronic intoxication.
PMCID: PMC3226429  PMID: 22093686
10.  Severe inflammatory reaction induced by peritoneal trauma is the key driving mechanism of postoperative adhesion formation 
BMC Surgery  2011;11:30.
Many factors have been put forward as a driving mechanism of surgery-triggered adhesion formation (AF). In this study, we underline the key role of specific surgical trauma related with open surgery (OS) and laparoscopic (LS) conditions in postoperative AF and we aimed to study peritoneal tissue inflammatory reaction (TIR), remodelling specific complications of open surgery (OS) versus LS and subsequently evaluating AF induced by these conditions.
A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups. Specific traumatic OS conditions were induced by midline incision line (MIL) extension and tissue drying and specific LS conditions were remodelled by intraperitoneal CO2 insufflation at the 10 cm of water. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale. Statistical analysis was performed by the non-parametric t test and two-way ANOVA using Bonferroni post-tests.
More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p < 0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p < 0.05 at the 24th and 72nd; p < 0.01 - 120th and p < 0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p > 0.05). However larger adhesion size (41.67 ± 33.63) was observed after OS in comparison with LS (20.31 ± 16.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p = 0.03). Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.
MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences. CO2 insufflation however, led to moderate inflammation and less adhesion formation.
PMCID: PMC3266192  PMID: 22082071
11.  Efficacy of tranexamic acid in reducing blood loss in posterior lumbar spine surgery for degenerative spinal stenosis with instability: a retrospective case control study 
BMC Surgery  2011;11:29.
Degenerative spinal stenosis and instability requiring multilevel spine surgery has been associated with large blood losses. Factors that affect perioperative blood loss include time of surgery, surgical procedure, patient height, combined anterior/posterior approaches, number of levels fused, blood salvage techniques, and the use of anti-fibrinolytic medications. This study was done to evaluate the efficacy of tranexamic acid in reducing blood loss in spine surgery.
This retrospective case control study includes 97 patients who had to undergo surgery because of degenerative lumbar spinal stenosis and instability. All operations included spinal decompression, interbody fusion and posterior instrumentation (4-5 segments). Forty-six patients received 1 g tranexamic acid intravenous, preoperative and six hours and twelve hours postoperative; 51 patients without tranexamic acid administration were evaluated as a control group. Based on the records, the intra- and postoperative blood losses were measured by evaluating the drainage and cell saver systems 6, 12 and 24 hours post operation. Additionally, hemoglobin concentration and platelet concentration were reviewed. Furthermore, the number of red cell transfusions given and complications associated with tranexamic acid were assessed.
The postoperative hemoglobin concentration demonstrated a statistically significant difference with a p value of 0.0130 showing superiority for tranexamic acid use (tranexamic acid group: 11.08 g/dl, SD: 1.68; control group: 10.29 g/dl, SD: 1.39). The intraoperative cell saver volume and drainage volume after 24 h demonstrated a significant difference as well, which indicates a less blood loss in the tranexamic acid group than the control group. The postoperative drainage volume at12 hours showed no significant differences; nor did the platelet concentration Allogenic blood transfusion (two red cell units) was needed for eight patients in the tranexamic acid group and nine in the control group because of postoperative anemia. Complications associated with the administration of tranexamic acid, e.g. renal failure, deep vein thrombosis or pulmonary embolism did not occur.
This study suggests a less blood loss when administering tranexamic acid in posterior lumbar spine surgery as demonstrated by the higher postoperative hemoglobin concentration and the less blood loss. But given the relatively small volume of blood loss in the patients of this study it is underpowered to show a difference in transfusion rates.
PMCID: PMC3234174  PMID: 22047046
12.  The natural history of pedal puncture wounds in diabetics: a cross-sectional survey 
BMC Surgery  2011;11:27.
Surgeons usually witness only the limb-threatening stages of infected, closed pedal puncture wounds in diabetics. Given that this catastrophic outcome often represents failure of conservative management of pre-infected wounds, some suggest consideration of invasive intervention (coring or laying-open) for pre-infected wounds in hope of preventing contamination from evolving into infection, there being no evidence based guidelines. However, an invasive pre-emptive approach is only justifiable if the probability of progression to catastrophic infection is very high. Literature search revealed no prior studies on the natural history of closed pedal puncture wounds in diabetics.
A survey was conducted via an interviewer-administered questionnaire on 198 adult diabetics resident in the parish of St. James, Jamaica. The sample was selected using a purposive technique designed to mirror the social gradient and residential distribution of the target population and is twice the number needed to detect a prevalence of puncture wounds of 14% with a range of 7-21% in a random sample of the estimated adult diabetic population.
The prevalence of a history of at least one closed pedal puncture wound since diagnosis of diabetes was 25.8% (CI; 19.6-31.9%). The only modifiable variable associated at the 5% level of significance with risk of pedal puncture wound, after adjustment by multivariable logistic regression, was site of interview/paying status, a variable substantially reflective of income more so than quality-of-care.
Of 77 reported episodes of closed pedal puncture wound among 51 participants, 45.4% healed without medical intervention, 27.3% healed after non-surgical treatment by a doctor and 27.3% required surgical intervention ranging from debridement to below-knee amputation. Anesthetic foot (failure to feel the puncture) and sole of the forefoot as site of puncture were the variables significantly associated with risk of requiring surgical intervention.
That 72.7% of wounds healed either spontaneously or after non-surgical treatment means that routine, non-selective surgical intervention for pre-infected closed pedal puncture wounds in diabetics is not justifiable. However the subset of patients with an anesthetic foot and a wound on the sole of the forefoot should be marked for intensive surveillance and early surgical intervention if infection occurs.
Trial Registration NCT01151891
PMCID: PMC3209435  PMID: 22004373
13.  Sleep study, respiratory mechanics, chemosensitive response and quality of life in morbidly obese patients undergoing bariatric surgery: a prospective, randomized, controlled trial 
BMC Surgery  2011;11:28.
Obesity is a major public health problem in both developed and developing countries alike and leads to a series of changes in respiratory physiology. There is a strong correlation between obesity and cardiopulmonary sleep disorders. Weight loss among such patients leads to a reduction in these alterations in respiratory physiology, but clinical treatment is not effective for a long period of time. Thus, bariatric surgery is a viable option.
The present study involves patients with morbid obesity (BMI of 40 kg/m2 or 35 kg/m2 to 39.9 kg/m2 with comorbidities), candidates for bariatric surgery, screened at the Santa Casa de Misericórdia Hospital in the city of Sao Paulo (Brazil). The inclusion criteria are grade III morbid obesity, an indication for bariatric surgery, agreement to participate in the study and a signed term of informed consent. The exclusion criteria are BMI above 55 kg/m2, clinically significant or unstable mental health concerns, an unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment. Bariatric surgery candidates who meet the inclusion criteria will be referred to Santa Casa de Misericórdia Hospital and will be reviewed again 30, 90 and 360 days following surgery. Data collection will involve patient records, personal data collection, objective assessment of HR, BP, neck circumference, chest and abdomen, collection and analysis of clinical preoperative findings, polysomnography, pulmonary function test and a questionnaire on sleepiness.
This paper describes a randomised controlled trial of morbidly obese patients. Polysomnography, respiratory mechanics, chemosensitive response and quality of life will be assessed in patients undergoing or not undergoing bariatric surgery.
Trial Registration
The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-9k9hhv).
PMCID: PMC3213198  PMID: 22004426
14.  Will emergency and surgical patients participate in and complete alcohol interventions? A systematic review 
BMC Surgery  2011;11:26.
In the everyday surgical life, staff may experience that patients with Alcohol Use Disorders (AUDs) seem reluctant to participate in alcohol intervention programs. The objective was therefore to assess acceptance of screening and intervention as well as adherence to the intervention program among emergency department (ED) and surgical patients with AUDs.
A systematic literature search was followed by extraction of acceptance and adherence rates in ED and surgical patients. Numbers needed to screen (NNS) were calculated. Subgroup analyses were carried out based on different study characteristics.
The literature search revealed 33 relevant studies. Of these, 31 were randomized trials, 28 were conducted in EDs and 31 evaluated the effect of brief alcohol intervention. Follow-up was mainly conducted after six and/or twelve months.
Four in five ED patients accepted alcohol screening and two in three accepted participation in intervention. In surgical patients, two in three accepted screening and the intervention acceptance rate was almost 100%. The adherence rate was above 60% for up to twelve months in both ED and surgical patients. The NNS to identify one eligible AUD patient and to get one eligible patient to accept participation in alcohol intervention varied from a few up to 70 patients.
The rates did not differ between randomized and non-randomized trials, brief and intensive interventions or validated and self-reported alcohol consumption. Adherence rates were not affected by patients' group allocation and type of follow-up.
Most emergency and surgical patients with AUD accept participation in alcohol screening and interventions and complete the intervention program.
PMCID: PMC3189859  PMID: 21943382
15.  Long term outcome and quality of life after open incisional hernia repair - light versus heavy weight meshes 
BMC Surgery  2011;11:25.
Mesh repair of incisional hernia is superior to the conventional technique. From all available materials for open surgery polypropylene (PP) is the most widely used. Development resulted in meshes with larger pore size, decreased mesh surface and lower weight. The aim of this retrospective non randomized study was to compare the quality of life in the long term follow up (> 72 month) after incisional hernia repair with "light weight"(LW) and "heavy weight"(HW) PP meshes.
12 patients who underwent midline open incisional hernia repair with a HW-PP mesh (Prolene® 109 g/m2 pore size 1.6 mm) between January 1996 and December 1997 were compared with 12 consecutive patients who underwent the same procedure with a LW-PP mesh (Vypro® 54 g/m2, pore size 4-5 mm) from January 1998. The standard technique was the sublay mesh-plasty with the retromuscular positioning of the mesh. The two groups were equal in BMI, age, gender and hernia size. Patients were routinely seen back in the clinic.
In the long term run (mean follow up 112 ± 22 months) patients of the HW mesh group revealed no significant difference in the SF-36 Health Survey domains compared to the LW group (mean follow up 75 ± 16 months).
In this study the health related quality of life based on the SF 36 survey after open incisional hernia repair with light or heavy weight meshes is not related to the mesh type in the long term follow up.
PMCID: PMC3180243  PMID: 21917180
incisional hernia repair; heavy weight; low weight polypropylene mesh; quality of life
16.  Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial) 
BMC Surgery  2011;11:24.
Emerging attempts have been made to reduce operative trauma and improve cosmetic results of laparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural transluminal endoscopic surgery (NOTES) and single-port laparoscopic cholecystectomy (SPLC). Many retrospective case series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a randomized controlled trial, patient's satisfaction on cosmesis is still controversially debated.
The SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study comparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC) in elective surgery. The hypothesis and primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image 12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type questionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks after surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by a visual analogue scale and the use of analgesics. Operative time, surgeon's experience with SPLC and 4PLC, use of additional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intra- and postoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned either to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th postoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05 and beta = 0.90, drop out rate of 10%) resulted in a number of 55 randomized patients per arm.
The SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess cosmesis and body image after SPLC.
Trial registration
( NCT 01278472
PMCID: PMC3189390  PMID: 21910897
17.  A three-dimensional model of error and safety in surgical health care microsystems. Rationale, development and initial testing 
BMC Surgery  2011;11:23.
Research estimates of inadvertent harm to patients undergoing modern healthcare demonstrate a serious problem. Much attention has been paid to analysis of the causes of error and harm, but researchers have typically focussed either on human interaction and communication or on systems design, without fully considering the other components. Existing models for analysing harm are principally derived from theory and the analysis of individual incidents, and their practical value is often limited by the assumption that identifying causal factors automatically suggests solutions. We suggest that new models based on observation are required to help analyse healthcare safety problems and evaluate proposed solutions. We propose such a model which is directed at "microsystem" level (Ward and operating theatre), and which frames problems and solutions within three dimensions.
We have developed a new, simple, model of safety in healthcare systems, based on analysis of real problems seen in surgical systems, in which influences on risk at the "microsystem" level are described in terms of only 3 dimensions - technology, system and culture. We used definitions of these terms which are similar or identical to those used elsewhere in the safety literature, and utilised a set of formal empirical and deductive processes to derive the model. The "3D" model assumes that new risks arise in an unpredictable stochastic manner, and that the three defined dimensions are interactive, in an unconstrained fashion. We illustrated testing of the model, using analysis of a small number of incidents in a surgical environment for which we had detailed prospective observational data.
The model appeared to provide useful explanation and categorisation of real events. We made predictions based on the model, which are experimentally verifiable, and propose further work to test and refine it.
We suggest that, if calibrated by application to a large incident dataset, the 3D model could form the basis for a quantitative statistical method for estimating risk at microsystem levels in many acute healthcare settings.
PMCID: PMC3178466  PMID: 21892929
Patient safety; surgery; medical error; theory, system; culture
18.  Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607) 
BMC Surgery  2011;11:22.
Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique.
The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention.
The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection.
Trial Registration NCT01049607
PMCID: PMC3177759  PMID: 21888669
19.  Predictors of surgical site infections among patients undergoing major surgery at Bugando Medical Centre in Northwestern Tanzania 
BMC Surgery  2011;11:21.
Surgical site infection (SSI) continues to be a major source of morbidity and mortality in developing countries despite recent advances in aseptic techniques. There is no baseline information regarding SSI in our setting therefore it was necessary to conduct this study to establish the prevalence, pattern and predictors of surgical site infection at Bugando Medical Centre Mwanza (BMC), Tanzania.
This was a cross-sectional prospective study involving all patients who underwent major surgery in surgical wards between July 2009 and March 2010. After informed written consent for the study and HIV testing, all patients who met inclusion criteria were consecutively enrolled into the study. Pre-operative, intra-operative and post operative data were collected using standardized data collection form. Wound specimens were collected and processed as per standard operative procedures; and susceptibility testing was done using disc diffusion technique. Data were analyzed using SPSS software version 15 and STATA.
Surgical site infection (SSI) was detected in 65 (26.0%) patients, of whom 56 (86.2%) and 9 (13.8%) had superficial and deep SSI respectively. Among 65 patients with clinical SSI, 56(86.2%) had positive aerobic culture. Staphylococcus aureus was the predominant organism 16/56 (28.6%); of which 3/16 (18.8%) were MRSA. This was followed by Escherichia coli 14/56 (25%) and Klebsiella pneumoniae 10/56 (17.9%). Among the Escherichia coli and Klebsiella pneumoniae isolates 9(64.3%) and 8(80%) were ESBL producers respectively. A total of 37/250 (14.8%) patients were HIV positive with a mean CD4 count of 296 cells/ml. Using multivariate logistic regression analysis, presence of pre-morbid illness (OR = 6.1), use of drain (OR = 15.3), use of iodine alone in skin preparation (OR = 17.6), duration of operation ≥ 3 hours (OR = 3.2) and cigarette smoking (OR = 9.6) significantly predicted surgical site infection (SSI)
SSI is common among patients admitted in surgical wards at BMC and pre-morbid illness, use of drain, iodine alone in skin preparation, prolonged duration of the operation and cigarette smoking were found to predict SSI. Prevention strategies focusing on factors associated with SSI is necessary in order to reduce the rate of SSI in our setting.
PMCID: PMC3175437  PMID: 21880145
20.  A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions 
BMC Surgery  2011;11:20.
The median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure.
The STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life.
A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratio's are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure.
The STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or for the commonly used large bites technique.
Trial registration NCT01132209
PMCID: PMC3182877  PMID: 21871072
21.  Early complications after biliary enteric anastomosis for benign diseases: A retrospective analysis 
BMC Surgery  2011;11:19.
Biliary-enteric anastomosis (BEA) is a common surgical procedure performed for the management of biliary obstruction or leakage that results from a variety of benign and malignant diseases. Complications following BEA are not rare. We aimed to determine the incidence and the factors associated with early complications occurring after BEA for benign diseases.
We reviewed the medical records of all patients who underwent BEA for benign diseases at our institution between January 1988 and December 2009. The primary outcome was early post operative complication. Logistic regression analysis was done to identify factors predicting the occurrence of complications.
Records of 79 patients were reviewed. There were 34 (43%) males and 45 (57% females). Majority (53%) had choledocholithiasis with impacted stone or distal stricture, followed by traumatic injury to the biliary system (33%). Thirty-four patients (43%) underwent a hepaticojejunostomy, 19 patients (24%) underwent a choledochojejunostomy, and choledochoduodenostomy was performed in 26 patients (33%). Early complications occurred in 39 (49%) patients - 41% had local complications and 25% had systemic complications. Most frequent complications were wound infection (23%) and bile leak (10%). Four (5%) patients died. On multivariate analysis, low serum albumin level (odds ratio = 16, 95% CI = 1.14-234.6) and higher ASA levels (odds ratio = 7, 95% CI: 1.22-33.34) were the independent factors predicting the early complications following BEA.
Half of the patients who underwent BEA for benign diseases had complications in our population. This high incidence may be explained by the high incidence of hypoalbuminemia and the high-risk group who underwent operation.
PMCID: PMC3176468  PMID: 21864413
22.  The impact of open versus closed format ICU admission practices on the outcome of high risk surgical patients: a cohort analysis 
BMC Surgery  2011;11:18.
In the year 2000, the organizational structure of the ICU in the Zaandam Medical Centre (ZMC) changed from an open to a closed format ICU. The objective of this study was to evaluate the effect of this organizational change on outcome in high risk surgical patients.
The medical records of all consecutive high risk surgical patients admitted to the ICU from 1996 to 1998 (open format) and from 2003 to 2005 (closed format), were reviewed. High-risk patients were defined according to the Identification of Risk in Surgical patients (IRIS) score. Parameters studied were: mortality, morbidity, ICU length of stay (LOS) and hospital LOS.
Mortality of ICU patients was 25.7% in the open format group and 15.8% in the closed format group (p = 0.01). Morbidity decreased from 48.6% to 46.1% (p = 0.6). The average length of hospital stay was 17 days in the open format group, and 21 days in the closed format group (p = 0.03).
High risk surgical patients in the ICU are patients that have undergone complex and often extensive surgery. These patients are in need of specialized treatment and careful monitoring for maximum safety and optimal care. Our results suggest that closed format is a more favourable setting than open format to minimize the effects of high risk surgery, and to warrant safe outcome in this patient group.
PMCID: PMC3176467  PMID: 21861878
23.  Impact of age on outcome after colorectal cancer surgery in the elderly - a developing country perspective 
BMC Surgery  2011;11:17.
Colorectal cancer (CRC) is a major source of morbidity and mortality in the elderly population and surgery is often the only definitive management option. The suitability of surgical candidates based on age alone has traditionally been a source of controversy. Surgical resection may be considered detrimental in the elderly solely on the basis of advanced age. Based on recent evidence suggesting that age alone is not a predictor of outcomes, Western societies are increasingly performing definitive procedures on the elderly. Such evidence is not available from our region. We aimed to determine whether age has an independent effect on complications after surgery for colorectal cancer in our population.
A retrospective review of all patients who underwent surgery for pathologically confirmed colorectal cancer at Aga Khan University Hospital, Karachi between January 1999 and December 2008 was conducted. Using a cut-off of 70 years, patients were divided into two groups. Patient demographics, tumor characteristics and postoperative complications and 30-day mortality were compared. Multivariate logistic regression analysis was performed with clinically relevant variables to determine whether age had an independent and significant association with the outcome.
A total of 271 files were reviewed, of which 56 belonged to elderly patients (≥ 70 years). The gender ratio was equal in both groups. Elderly patients had a significantly higher comorbidity status, Charlson score and American society of anesthesiologists (ASA) class (all p < 0.001). Upon multivariate analysis, factors associated with more complications were ASA status (95% CI = 1.30-6.25), preoperative perforation (95% CI = 1.94-48.0) and rectal tumors (95% CI = 1.21-5.34). Old age was significantly associated with systemic complications upon univariate analysis (p = 0.05), however, this association vanished upon multivariate analysis (p = 0.36).
Older patients have more co-morbid conditions and higher ASA scores, but increasing age itself is not independently associated with complications after surgery for CRC. Therefore patient selection should focus on the clinical status and ASA class of the patient rather than age.
PMCID: PMC3175436  PMID: 21849062
24.  Safety of liver resection and effect on quality of life in patients with benign hepatic disease: Single center experience 
BMC Surgery  2011;11:16.
Although liver resection has long been established for selected patients with benign hepatic disease, the success of surgical treatment of these patients cannot be evaluated exclusively through postoperative morbidity and mortality. Therefore, the aim of the study was to prove the safety of liver resection in the treatment of benign liver tumors and to evaluate the effect of surgical treatment on the patients' qauality of life.
A total of 146 patients who underwent liver resection because of benign liver tumors were included in this study. Postoperative outcome was assessed and patients evaluated their quality of life before surgery and at the present time using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ C-30).
The rate of serious (> grade 2) complications was 4.1% with no postoperative death. The quality of life assessment revealed an overall improvement of general health status after resection (0.7 vs. 0.56, p < 0.001) and additionally a significant reduction of 6 out of 9 symptoms. Furthermore, compelling benefits in the patients' social and emotional coping could be detected after surgery.
Liver resection for benign liver disease is a safe procedure and leads to a significant improvement of quality of life in selected patients.
PMCID: PMC3163509  PMID: 21791063
25.  Topical haemostatic agents for skin wounds: a systematic review 
BMC Surgery  2011;11:15.
Various agents and techniques have been introduced to limit intra-operative blood loss from skin lesions. No uniformity regarding the type of haemostasis exists and this is generally based on the surgeon's preference. To study the effectiveness of haemostatic agents, standardized wounds like donor site wounds after split skin grafting (SSG) appear particularly suitable. Thus, we performed a systematic review to assess the effectiveness of haemostatic agents in donor site wounds.
We searched all randomized clinical trials (RCTs) on haemostasis after SSG in Medline, Embase and the Cochrane Library until January 2011. Two reviewers independently assessed trial relevance and quality and performed data analysis. Primary endpoint was effectiveness regarding haemostasis. Secondary endpoints were wound healing, adverse effects, and costs.
Nine relevant RCTs with a fair methodological quality were found, comparing epinephrine, thrombin, fibrin sealant, alginate dressings, saline, and mineral oil. Epinephrine achieved haemostasis significantly faster than thrombin (difference up to 2.5 minutes), saline or mineral oil (up to 6.5 minutes). Fibrin sealant also resulted in an up to 1 minute quicker haemostasis than thrombin and up to 3 minutes quicker than placebo, but was not directly challenged against epinephrine. Adverse effects appeared negligible. Due to lack of clinical homogeneity, meta-analysis was impossible.
According to best available evidence, epinephrine and fibrin sealant appear superior to achieve haemostasis when substantial topical blood loss is anticipated, particularly in case of (larger) SSGs and burn debridement.
PMCID: PMC3143913  PMID: 21745412

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