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1.  Management of gastro-bronchial fistula complicating a subtotal esophagectomy: a case report 
BMC Surgery  2009;9:20.
Background
The development of a fistula between the tracheobronchial tree and the gastric conduit post esophagectomy is a rare and often fatal complication.
Case presentation
A 68 year old man underwent radical esophagectomy for esophageal adenocarcinoma. On postoperative day 14 the nasogastric drainage bag dramatically filled with air, without deterioration in respiratory function or progressive sepsis. A fiberoptic bronchoscopy was performed which demonstrated a gastro-bronchial fistula in the posterior aspect of the left main bronchus. He was managed conservatively with antibiotics, enteral nutrition via jejunostomy, and non-invasive respiratory support. A follow- up bronchoscopy 60 days after the diagnostic bronchoscopy, confirmed spontaneous closure of the fistula
Conclusions
This is the first such case where a conservative approach with no surgery or endoprosthesis resulted in a successful outcome, with fistula closure confirmed at subsequent bronchoscopy. Our experience would suggest that in very carefully selected cases where bronchopulmonary contamination from the fistula is minimal or absent, there is no associated inflammation of the tracheobronchial tree and the patient is stable from a respiratory point of view without evidence of sepsis, there may be a role for a trial of conservative management.
doi:10.1186/1471-2482-9-20
PMCID: PMC2803445  PMID: 20030856
2.  Laparoscopic retrograde (fundus first) cholecystectomy 
BMC Surgery  2009;9:19.
Background
Retrograde ("fundus first") dissection is frequently used in open cholecystectomy and although feasible in laparoscopic cholecystectomy (LC) it has not been widely practiced. LC is most simply carried out using antegrade dissection with a grasper to provide cephalad fundic traction. A series is presented to investigate the place of retrograde dissection in the hands of an experienced laparoscopic surgeon using modern instrumentation.
Methods
A prospective record of all LCs carried out by an experienced laparoscopic surgeon following his appointment in Bristol in 2004 was examined. Retrograde dissection was resorted to when difficulties were encountered with exposure and/or dissection of Calot's triangle.
Results
1041 LCs were carried out including 148 (14%) emergency operations and 131 (13%) associated bile duct explorations. There were no bile duct injuries although conversion to open operation was required in six patients (0.6%). Retrograde LC was attempted successfully in 11 patients (1.1%). The age ranged from 28 to 80 years (mean 61) and there were 7 males. Indications were; fibrous, contracted gallbladder 7, Mirizzi syndrome 2 and severe kyphosis 2. Operative photographs are included to show the type of case where it was needed and the technique used. Postoperative stay was 1/2 to 5 days (mean 2.2) with no delayed sequelae on followup. Histopathology showed; chronic cholecystitis 7, xanthogranulomatous cholecystitis 3 and acute necrotising cholecystitis 1.
Conclusions
In this series, retrograde laparoscopic dissection was necessary in 1.1% of LCs and a liver retractor was needed in 9 of the 11 cases. This technique does have a place and should be in the armamentarium of the laparoscopic surgeon.
doi:10.1186/1471-2482-9-19
PMCID: PMC2801662  PMID: 20003333
3.  Risk factors for early recurrence after inguinal hernia repair 
BMC Surgery  2009;9:18.
Background
Family history, male gender and age are significant risk factors for inguinal hernia disease. Family history provides evidence for a genetic trait and could explain early recurrence after inguinal hernia repair despite technical advance at least in a subgroup of patients. This study evaluates if age and family history can be identified as risk factors for early recurrence after primary hernia repair.
Methods
We performed an observational cohort study for 75 patients having at least two recurrent hernias. The impact of age, gender and family history on the onset of primary hernias, age at first recurrence and recurrence rates was investigated.
Results
44% (33/75) of recurrent hernia patients had a family history and primary as well as recurrent hernias occurred significantly earlier in this group (p = 0.04). The older the patients were at onset the earlier they got a recurrent hernia. Smoking could be identified as on additional risk factor for early onset of hernia disease but not for hernia recurrence.
Conclusion
Our data reveal an increased incidence of family history for recurrent hernia patients when compared with primary hernia patients. Patients with a family history have their primary hernias as well as their recurrence at younger age then patients without a family history. Though recurrent hernia has to be regarded as a disease caused by multiple factors, a family history may be considered as a criterion to identify the risk for recurrence before the primary operation.
doi:10.1186/1471-2482-9-18
PMCID: PMC2795732  PMID: 20003183
4.  Increased incidence of postoperative infections during prophylaxis with cephalothin compared to doxycycline in intestinal surgery 
BMC Surgery  2009;9:17.
Background
The antibiotics used for prophylaxis during surgery may influence the rate of surgical site infections. Tetracyclines are attractive having a long half-life and few side effects when used in a single dose regimen. We studied the rate of surgical site infections during changing regimens of antibiotic prophylaxis in medium and major size surgery.
Methods
Prospective registration of surgical site infection following intestinal resections and hysterectomies was performed. Possible confounding procedure and patient related factors were registered. The study included 1541 procedures and 1489 controls. The registration included time periods when the regimen was changed from doxycycline to cephalothin and back again.
Results
The SSI in the colorectal department increased from 19% to 30% (p = 0.002) when doxycycline was substituted with cephalothin and decreased to 17% when we changed back to doxycycline (p = 0.005). In the gynaecology department the surgical site infection rate did not increase significantly. Subgroup analysis showed major changes in infections in rectal resections from 20% to 35% (p = 0.02) and back to 12% (p = 0.003).
Conclusion
Doxycycline combined with metronidazole, is an attractive candidate for antibiotic prophylaxis in medium and major size intestinal surgery.
doi:10.1186/1471-2482-9-17
PMCID: PMC2796642  PMID: 19968872
5.  Internal sphincterotomy reduces postoperative pain after Milligan Morgan haemorrhoidectomy 
BMC Surgery  2009;9:16.
Background
Over the last few years, there has been increasing attention on surgical procedures to treat haemorrhoids. The Milligan-Morgan haemorrhoidectomy is still one of the most popular surgical treatments of haemorrhoids. The aim of the present work is to assess postoperative pain, together with other early and late complications, after Milligan-Morgan haemorrhoidectomy as we could observe in our experience before and after performing an internal sphincterotomy.
Methods
from January 1980 to May 2007, we operated 850 patients, but only 699 patients (median age 53) were included in the present study because they satisfied our inclusion criteria. The patients were divided into two groups: all the patients operated on before 1995 (group A); all the patients operated on after 1995 (group B). Since 1995 an internal sphincterotomy of about 1 cm has been performed at the end of the procedure. The data concerning the complications of these two groups were compared. All the patients received a check-up at one and six months after operation and a telephone questionnaire three years after operation to evalue medium and long term results.
Results
after one month 507 patients (72.5%) did not have any postoperative complication. Only 192 patients (27.46%) out of 699 presented postoperative complication and the most frequent one (23.03%) was pain. The number of patients who suffered from postoperative pain decreased significantly when performing internal sphincterotomy, going from 28.8% down to 10.45% (χ2: 10,880; p = 0,0001); 95% Confidence Interval (CI) 24.7 to 28.9 (group A) and 10.17 to 10.72 (group B). In 51 cases (7.29%) urinary retention was registered. Six cases of bleeding (0.85%) were registered. Medium and long term follow up did not show any difference among the two groups.
Conclusion
internal sphincterotomy: reduces significantly pain only in the first postoperative period, but not in the medium-long term follow up; does not increase the incidence of continence impairment when performed; does not influence the incidence of the other postoperative complications especially as regard medium and long term results.
doi:10.1186/1471-2482-9-16
PMCID: PMC2774293  PMID: 19852840
6.  Evolution of breast cancer management in Ireland: a decade of change 
BMC Surgery  2009;9:15.
Background
Over the last decade there has been a paradigm shift in the management of breast cancer, subsequent to revised surgical oncology guidelines and consensus statements which were derived in light of landmark breast cancer clinical trials conducted throughout the latter part of the 20th century. However the sheer impact of this paradigm shift upon all modalities of treatment, and the current trends in management of the disease, are largely unknown. We aimed to assess the changing practices of breast cancer management over the last decade within a specialist tertiary referral Breast Cancer Centre.
Methods
Comparative analysis of all aspects of the management of breast cancer patients, who presented to a tertiary referral Breast Cancer Centre in 1995/1996 and 2005/2006, was undertaken and measured against The European Society for Surgical Oncology guidelines for the surgical management of mammographically detected lesions [1998].
Results
613 patients' case profiles were analysed. Over the last decade we observed a dramatic increase in incidence of breast cancer [>100%], a move to less invasive diagnostic and surgical therapeutic techniques, as well as increased use of adjuvant therapies. We also witnessed the introduction of immediate breast reconstruction as part of routine practice
Conclusion
We demonstrate that radical changes have occurred in the management of breast cancer in the last decade, in keeping with international guidelines. It remains incumbent upon us to continue to adapt our practice patterns in light of emerging knowledge and best evidence.
doi:10.1186/1471-2482-9-15
PMCID: PMC2753567  PMID: 19765289
7.  Laparoscopic versus open left lateral segmentectomy 
BMC Surgery  2009;9:14.
Background
Laparoscopic liver surgery is becoming increasingly common. This cohort study was designed to directly compare perioperative outcomes of the left lateral segmentectomy via laparoscopic and open approach.
Methods
Between 2002 and 2006 43 left lateral segmentectomies were performed at King's College Hospital. Those excluded from analysis included previous liver resections, polycystic liver disease, liver cirrhosis and synchronous operations. Of 20 patients analysed, laparoscopic (n = 10) were compared with open left lateral segmentectomy (n = 10). Both groups had similar patient characteristics.
Results
Morbidity rates were similar with no wound or chest infection in either group. The conversion rate was 10% (1/10). There was no difference in operating time between the groups (median time 220 minutes versus 179 minutes, p = 0.315). Surgical margins for all lesions were clear. Less postoperative opiate analgesics were required in the laparoscopic group (median 2 days versus 5 days, p = 0.005). The median postoperative in-hospital stay was less in the laparoscopic group (6 days vs 9 days, p = 0.005). There was no mortality.
Conclusion
Laparoscopic left lateral segmentectomy is safe and feasible. Laparoscopic patients may benefit from requiring less postoperative opiate analgesia and a shorter post-operative in-hospital stay.
doi:10.1186/1471-2482-9-14
PMCID: PMC2742511  PMID: 19735573
8.  Prediction of conversion of laparoscopic cholecystectomy to open surgery with artificial neural networks 
BMC Surgery  2009;9:13.
Background
The intent of this study was to predict conversion of laparoscopic cholecystectomy (LC) to open surgery employing artificial neural networks (ANN).
Methods
The retrospective data of 793 patients who underwent LC in a teaching university hospital from 1997 to 2004 was collected. We employed linear discrimination analysis and ANN models to examine the predictability of the conversion. The models were validated using prospective data of 100 patients who underwent LC at the same hospital.
Results
The overall conversion rate was 9%. Conversion correlated with experience of surgeons, emergency LC, previous abdominal surgery, fever, leukocytosis, elevated bilirubin and alkaline phosphatase levels, and ultrasonographic detection of common bile duct stones. In the validation group, discriminant analysis formula diagnosed the conversion in 5 cases out of 9 (sensitivity: 56%; specificity: 82%); the ANN model diagnosed 6 cases (sensitivity: 67%; specificity: 99%).
Conclusion
The conversion of LC to open surgery is effectively predictable based on the preoperative health characteristics of patients using ANN.
doi:10.1186/1471-2482-9-13
PMCID: PMC2745364  PMID: 19698100
9.  Development of a clinical decision model for thyroid nodules 
BMC Surgery  2009;9:12.
Background
Thyroid nodules represent a common problem brought to medical attention. Four to seven percent of the United States adult population (10–18 million people) has a palpable thyroid nodule, however the majority (>95%) of thyroid nodules are benign. While, fine needle aspiration remains the most cost effective and accurate diagnostic tool for thyroid nodules in current practice, over 20% of patients undergoing FNA of a thyroid nodule have indeterminate cytology (follicular neoplasm) with associated malignancy risk prevalence of 20–30%. These patients require thyroid lobectomy/isthmusectomy purely for the purpose of attaining a definitive diagnosis. Given that the majority (70–80%) of these patients have benign surgical pathology, thyroidectomy in these patients is conducted principally with diagnostic intent. Clinical models predictive of malignancy risk are needed to support treatment decisions in patients with thyroid nodules in order to reduce morbidity associated with unnecessary diagnostic surgery.
Methods
Data were analyzed from a completed prospective cohort trial conducted over a 4-year period involving 216 patients with thyroid nodules undergoing ultrasound (US), electrical impedance scanning (EIS) and fine needle aspiration cytology (FNA) prior to thyroidectomy. A Bayesian model was designed to predict malignancy in thyroid nodules based on multivariate dependence relationships between independent covariates. Ten-fold cross-validation was performed to estimate classifier error wherein the data set was randomized into ten separate and unique train and test sets consisting of a training set (90% of records) and a test set (10% of records). A receiver-operating-characteristics (ROC) curve of these predictions and area under the curve (AUC) were calculated to determine model robustness for predicting malignancy in thyroid nodules.
Results
Thyroid nodule size, FNA cytology, US and EIS characteristics were highly predictive of malignancy. Cross validation of the model created with Bayesian Network Analysis effectively predicted malignancy [AUC = 0.88 (95%CI: 0.82–0.94)] in thyroid nodules. The positive and negative predictive values of the model are 83% (95%CI: 76%–91%) and 79% (95%CI: 72%–86%), respectively.
Conclusion
An integrated predictive decision model using Bayesian inference incorporating readily obtainable thyroid nodule measures is clinically relevant, as it effectively predicts malignancy in thyroid nodules. This model warrants further validation testing in prospective clinical trials.
doi:10.1186/1471-2482-9-12
PMCID: PMC2731077  PMID: 19664278
10.  APACHE III outcome prediction in patients admitted to the intensive care unit after liver transplantation: a retrospective cohort study 
BMC Surgery  2009;9:11.
Background
The Acute Physiology and Chronic Health Evaluation (APACHE) III prognostic system has not been previously validated in patients admitted to the intensive care unit (ICU) after orthotopic liver transplantation (OLT). We hypothesized that APACHE III would perform satisfactorily in patients after OLT
Methods
A retrospective cohort study was performed. Patients admitted to the ICU after OLT between July 1996 and May 2008 were identified. Data were abstracted from the institutional APACHE III and liver transplantation databases and individual patient medical records. Standardized mortality ratios (with 95% confidence intervals) were calculated by dividing the observed mortality rates by the rates predicted by APACHE III. The area under the receiver operating characteristic curve (AUC) and the Hosmer-Lemeshow C statistic were used to assess, respectively, discrimination and calibration of APACHE III.
Results
APACHE III data were available for 918 admissions after OLT. Mean (standard deviation [SD]) APACHE III (APIII) and Acute Physiology (APS) scores on the day of transplant were 60.5 (25.8) and 50.8 (23.6), respectively. Mean (SD) predicted ICU and hospital mortality rates were 7.3% (15.4) and 10.6% (18.9), respectively. The observed ICU and hospital mortality rates were 1.1% and 3.4%, respectively. The standardized ICU and hospital mortality ratios with their 95% C.I. were 0.15 (0.07 to 0.27) and 0.32 (0.22 to 0.45), respectively.
There were statistically significant differences in APS, APIII, predicted ICU and predicted hospital mortality between survivors and non-survivors. In predicting mortality, the AUC of APACHE III prediction of hospital death was 0.65 (95% CI, 0.62 to 0.68). The Hosmer-Lemeshow C statistic was 5.288 with a p value of 0.871 (10 degrees of freedom).
Conclusion
APACHE III discriminates poorly between survivors and non-survivors of patients admitted to the ICU after OLT. Though APACHE III has been shown to be valid in heterogenous populations and in certain groups of patients with specific diagnoses, it should be used with caution – if used at all – in recipients of liver transplantation.
doi:10.1186/1471-2482-9-11
PMCID: PMC2726122  PMID: 19640303
11.  Radical Prostatectomy: Hospital volumes and surgical volumes – does practice make perfect? 
BMC Surgery  2009;9:10.
Background
Between the years 1993 and 2003, more than 140,000 men underwent radical prostatectomy (RP), thus making RP one of the most common treatment options for localized prostate cancer in the United States.
Discussion
Localized prostate cancer treated by RP is one of the more challenging procedures performed by urologic surgeons. Studies suggest a definite learning curve in performing this procedure with optimal results noted after performing >500 RPs. But is surgical volume everything? How do hospital volumes of RP weigh in? Could fellowship training in RP reduce the critical volume needed to reach an 'experienced' level?
Summary
As we continue to glean data as to how to optimize outcomes after RP, we must not only consider surgeon and hospital volumes of RP, but also consider training of the individual surgeon.
doi:10.1186/1471-2482-9-10
PMCID: PMC2701919  PMID: 19500401
12.  Diagnostic problems with parasitic and non-parasitic splenic cysts 
BMC Surgery  2009;9:9.
Background
The splenic cysts constitute a very rare clinical entity. They may occur secondary to trauma or even being more seldom due to parasitic infestations, mainly caused by ecchinocccus granulosus. Literature lacks a defined concencus including the treatment plans and follow up strategies, nor long term results of the patients. In the current study, we aimed to evaluate the diagnosis, management of patients with parasitic and non-parasitic splenic cysts together with their long term follow up progresses.
Methods
Twenty-four patients with splenic cysts have undergone surgery in our department over the last 9 years. Data from eighteen of the twenty-four patients were collected prospectively, while data from six were retrospectively collected. All patients were assessed in terms of age, gender, hospital stay, preoperative diagnosis, additional disease, serology, ultrasonography, computed tomography (CT), cyst recurrences and treatment.
Results
In this study, the majority of patients presented with abdominal discomfort and palpable swelling in the left hypochondrium. All patients were operated on electively. The patients included 14 female and 10 male patients, with a mean age of 44.77 years (range 20–62). Splenic hydatid cysts were present in 16 patients, one of whom also had liver hydatid cysts (6.25%). Four other patients were operated on for a simple cyst (16%) two patients for an epithelial cyst, and the last two for splenic lymphangioma. Of the 16 patients diagnosed as having splenic hydatit cysts, 11 (68.7%) were correctly diagnosed. Only two of these patients were administered benzimidazole therapy pre-operatively because of the risk of multicystic disease The mean follow-up period was 64 months (6–108). There were no recurrences of splenic cysts.
Conclusion
Surgeons should keep in mind the possibility of a parasitic cyst when no definitive alternative diagnosis can be made. In the treatment of splenic hydatidosis, benzimidazole therapy is not necessary, although it is crucial to perform splenectomy without rupturing and spilling the cysts.
doi:10.1186/1471-2482-9-9
PMCID: PMC2701920  PMID: 19476658
13.  Current practice of abdominal wall closure in elective surgery – Is there any consensus? 
BMC Surgery  2009;9:8.
Background
Development of incisional hernia after open abdominal surgery remains a major cause of post-operative morbidity. The aim of this study was to determine the current practice of surgeons in terms of access to and closure of the abdominal cavity in elective open surgery.
Methods
Twelve surgical departments of the INSECT-Trial group documented the following variables for 50 consecutive patients undergoing abdominal surgery: fascial closure techniques, applied suture materials, application of subcutaneous sutures, subcutaneous drains, methods for skin closure. Descriptive analysis was performed and consensus of treatment variables was categorized into four levels: Strong consensus >95%, consensus 75–95%, overall agreement 50–75%, no consensus <50%.
Results
157 out of 599 patients were eligible for analysis (85 (54%) midline, 54 (35%) transverse incisions). After midline incisions the fascia was closed continuously in 55 patients (65%), using slowly absorbable (n = 47, 55%), braided (n = 32, 38%) sutures with a strength of 1 (n = 48, 57%). In the transverse setting the fascia was closed continuously in 39 patients (72%) with slowly absorbable (n = 22, 41%) braided sutures (n = 27, 50%) with a strength of 1 (n = 30, 56%).
Conclusion
In the present evaluation midline incision was the most frequently applied access in elective open abdominal surgery. None of the treatments for abdominal wall closure (except skin closure in the midline group) is performed on a consensus level.
doi:10.1186/1471-2482-9-8
PMCID: PMC2687428  PMID: 19442311
14.  Intraoperative angiography should be standard in cerebral aneurysm surgery 
BMC Surgery  2009;9:7.
Intraoperative angiography (IOA) has proven to be a safe and effective adjunct to surgical repair of cerebral aneurysms. Substantial practice variation exists regarding use of this modality in different centers, including use of IOA routinely, selectively, or rarely. In this editorial, we discuss our experience and review the existing literature to develop an argument for routine use of IOA during cerebral aneurysm surgery.
doi:10.1186/1471-2482-9-7
PMCID: PMC2683796  PMID: 19405979
15.  Long-term recurrence and complication rates after incisional hernia repair with the open onlay technique 
BMC Surgery  2009;9:6.
Background
Incisional hernia after abdominal surgery is a well-known complication. Controversy still exists with respect to the choice of hernia repair technique. The objective of this study was to evaluate the long-term recurrence rate as well as surgical complications in a consecutive group of patients undergoing open repair using an onlay mesh technique.
Methods
Consecutive patients undergoing open incisional hernia repair with onlay-technique between 01/05/1995 and 01/09/2007 at a single institution were included in the study. For follow-up patients were contacted by telephone, and answered a questionnaire containing questions related to the primary operation, the hernia and general risk factors. Patients were examined by a consultant surgeon in the outpatient clinic or in the patient's home if there was suspicion of an incisional hernia recurrence.
Results
The study included 56 patients with 100% follow-up. The median follow-up was 35 months (range 4–151). Recurrent incisional hernia was found in 8 of 56 patients (15%, 95% CI: 6–24). The overall complication rate was 13% (95% CI, 4–22). All complications were minor and needed no hospital admission.
Conclusion
This study with a long follow-up showed low recurrence and complication rates in patients undergoing incisional hernia repair with the open onlay technique.
doi:10.1186/1471-2482-9-6
PMCID: PMC2684736  PMID: 19400934
16.  Direct intra-abdominal pressure monitoring via piezoresistive pressure measurement: a technical note 
BMC Surgery  2009;9:5.
Background
Piezoresistive pressure measurement technique (PRM) has previously been applied for direct IAP measurement in a porcine model using two different devices. Aim of this clinical study was to assess both devices regarding complications, reliability and agreement with IVP in patients undergoing elective abdominal surgery.
Methods
A prospective cohort study was performed in 20 patients randomly scheduled to receive PRM either by a Coach®-probe or an Accurate++®-probe (both MIPM, Mammendorf, Germany). Probes were placed on the greater omentum and passed through the abdominal wall paralleling routine drainages. PRM was compared with IVP measurement by t-testing and by calculating mean difference as well as limits of agreement (LA).
Results
There were no probe related complications. Due to technical limitations, data could be collected in 3/10 patients with Coach® and in 7/10 patients with Accurate++®. Analysis was carried out only for Accurate++®. Mean values did not differ to mean IVP values. Mean difference to IVP was 0.1 ± 2.8 mmHg (LA: -5.5 to 5.6 mmHg).
Conclusion
Direct IAP measurement was clinically uneventful. Although results of Accurate++® were comparable to IVP, the device might be too fragile for IAP measurements in the clinical setting. Local ethical committee trial registration: EK2024
doi:10.1186/1471-2482-9-5
PMCID: PMC2678082  PMID: 19383161
17.  Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study) 
BMC Surgery  2009;9:4.
Background
Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.
The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.
Methods/design
Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma ≥ 3 cm, located between 1–15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment.
Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures.
Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group.
Discussion
The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas.
Trial registration number
(trialregister.nl) NTR1422
doi:10.1186/1471-2482-9-4
PMCID: PMC2664790  PMID: 19284647
18.  Comparison of inpatient vs. outpatient anterior cervical discectomy and fusion: a retrospective case series 
BMC Surgery  2009;9:3.
Background
Spinal surgery is increasingly being done in the outpatient setting. We reviewed our experience with inpatient and outpatient single-level anterior cervical discectomy and fusion with plating (ACDF+P).
Methods
All patients undergoing single-level anterior cervical discectomy and fusion with plating between August 2005 and May 2007 by two surgeons (RPB or JAF) were retrospectively reviewed. All patients underwent anterior cervical microdiscectomy, arthrodesis using structural allograft, and titanium plating. A planned change from doing ACDF+P on an inpatient basis to doing ACDF+P on an outpatient basis was instituted at the midpoint of the study. There were no other changes in technique, patient selection, instrumentation, facility, or other factors. All procedures were done in full-service hospitals accommodating outpatient and inpatient care.
Results
64 patients underwent ACDF+P as inpatients, while 45 underwent ACDF+P as outpatients. When outpatient surgery was planned, 17 patients were treated as inpatients due to medical comorbidities (14), older age (1), and patient preference (2). At a mean follow-up of 62.4 days, 90 patients had an excellent outcome, 19 patients had a good outcome, and no patients had a fair or poor outcome. There was no significant difference in outcome between inpatients and outpatients. There were 4 complications, all occurring in inpatients: a hematoma one week post-operatively requiring drainage, a cerebrospinal fluid leak treated with lumbar drainage, syncope of unknown etiology, and moderate dysphagia.
Conclusion
In this series, outpatient ACDF+P was safe and was not associated with a significant difference in outcome compared with inpatient ACDF+P.
doi:10.1186/1471-2482-9-3
PMCID: PMC2657115  PMID: 19265540
19.  Sentinel lymph node biopsy for breast cancer using methylene blue dye manifests a short learning curve among experienced surgeons: a prospective tabular cumulative sum (CUSUM) analysis 
BMC Surgery  2009;9:2.
Background
The benefits of sentinel lymph node biopsy (SLNB) for breast cancer patients with histologically negative axillary nodes, in whom axillary lymph node dissection (ALND) is thereby avoided, are now established. Low false negative rate, certainly with blue dye technique, mostly reflects the established high inherent accuracy of SLNB and low axillary nodal metastatic load (subject to patient selection). SLN identification rate is influenced by volume, injection site and choice of mapping agent, axillary nodal metastatic load, SLN location and skill at axillary dissection. Being more subject to technical failure, SLN identification seems to be a more reasonable variable for learning curve assessment than false negative rate.
Methylene blue is as good an SLN mapping agent as Isosulfan blue and is much cheaper. Addition of radio-colloid mapping to blue dye does not achieve a sufficiently higher identification rate to justify the cost. Methylene blue is therefore the agent of choice for SLN mapping in developing countries.
The American Society of Breast Surgeons recommends that, for competence, surgeons should perform 20 SLNB but admits that the learning curve with a standardized technique may be "much shorter". One appropriate remedy for this dilemma is to plot individual learning curves.
Methods
Using methylene blue dye, experienced breast surgeons performed SLNB in selected patients with breast cancer (primary tumor < 5 cm and clinically negative ipsilateral axilla). Intraoperative assessment and completion ALND were performed for standardization on the first 13 of 24 cases. SLN identification was plotted for each surgeon on a tabular cumulative sum (CUSUM) chart with sequential probability ratio test (SPRT) limits based on a target identification rate of 85%.
Results
The CUSUM plot crossed the SPRT limit line after 8 consecutive, positively identified SLN, signaling achievement of an acceptable level of competence.
Conclusion
Tabular CUSUM charting, based on a justified choice of parameters, indicates that the learning curve for SLNB using methylene blue dye is completed after 8 consecutive, positively identified SLN. CUSUM charting may be used to plot individual learning curves for trainee surgeons by applying a proxy parameter for failure in the presence of a mentor (such as failed SLN identification within 15 minutes).
doi:10.1186/1471-2482-9-2
PMCID: PMC2640353  PMID: 19173714
20.  A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer 
BMC Surgery  2009;9:1.
Background
Pancreatic cancer is the fourth most common cause of cancer related death in Western countries. Advantages in surgical techniques, radiation and chemotherapy had almost no impact on the long term survival of affected patients. Therefore, the need for better treatment strategies is urgent. HER2, a receptor tyrosine kinase of the EGFR family, involved in signal transduction pathways leading to cell growth and differentiation is overexpressed in a number of cancers, including breast and pancreatic cancer. While in breast cancer HER2 has already been successfully used as a treatment target, there are only limited data evaluating the effects of inhibiting HER2 tyrosine kinases in patients with pancreatic cancer.
Methods
Here we report the design of a prospective, non-randomized multi-centered Phase II clinical study evaluating the effects of the Fluoropyrimidine-carbamate Capecitabine (Xeloda ®) and the monoclonal anti-HER2 antibody Trastuzumab (Herceptin®) in patients with non-resectable, HER2 overexpressing pancreatic cancer. Patients eligible for the study will receive Trastuzumab infusions on day 1, 8 and 15 concomitant to the oral intake of Capecitabine from day 1 to day 14 of each three week cylce. Cycles will be repeated until tumor progression. A total of 37 patients will be enrolled with an interim analysis after 23 patients.
Discussion
Primary end point of the study is to determine the progression free survival after 12 weeks of bimodal treatment with the chemotherapeutic agent Capecitabine and the anti-HER2 antibody Trastuzumab. Secondary end points include patient's survival, toxicity analysis, quality of life, the correlation of HER2 overexpression and clinical response to Trastuzumab treatment and, finally, the correlation of CA19-9 plasma levels and progression free intervals.
doi:10.1186/1471-2482-9-1
PMCID: PMC2661037  PMID: 19133157

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