A study of preoperative factors associated with a poor outcome following laparoscopic bile duct exploration.

BACKGROUND: The aim of this study was to identify preoperative factors associated with poor outcome following laparoscopic bile duct exploration. METHODS: Data regarding potential preoperative factors were collected prospectively and from a review of patient records of 436 patients who had undergone a laparoscopic bile duct exploration. A multivariate analysis was performed to identify significant predictors of five adverse outcomes: postoperative complication (stratified), conversion to open operation, prolonged hospital stay, bile leak following choledochotomy, and failure of surgical clearance of the duct. RESULTS: The mean age was 57 years (range = 18-91) and 74% were female. No complications were experienced by 66.5% and 17% had a minor Clavien Grade I complication. There was one death. Clinically significant Clavien Grade II-V complications occurred more frequently in those of increasing age [OR = 1.03 (CI = 1.01-1.05), p = 0.02]. Increasing serum bilirubin [OR = 1.01 (CI = 1.00-1.01), p = 0.01] was associated with conversion to an open operation. Male sex [OR = 0.52 (CI = 0.27-0.99), p = 0.05], previous upper abdominal surgery [OR = 4.89 (CI = 1.10-21.74), p = 0.04], immunosuppressants [OR = 9.75 (CI = 1.06-89.93), p = 0.05], and a larger preoperative common bile duct diameter [OR = 1.16 (CI = 1.08-1.25), p < 0.001] were predictors of a prolonged hospital stay. No factors were identified as predictors of a controlled bile leak. Previous failed ERCP was not associated with adverse outcome. CONCLUSION: Laparoscopic exploration of the bile duct is safe but age, comorbidity, and degree of jaundice increase the risk slightly.

Effect of Preoperative Weight Loss and Baseline Comorbidity on Short-Term Complications and Reoperations After Laparoscopic Roux-en-Y Gastric Bypass in 2,067 Patients.

PURPOSE: Decreasing popularity of Roux-en-Y gastric bypass (RYGB) in bariatric-metabolic surgery may be due to higher perceived peri-operative complications. There are few studies on whether preoperative weight loss can reduce complications or reoperations following RYGB. We investigated this using a standardised operative technique. MATERIALS AND METHODS: Retrospective single-centre study of RYGB from 2004 to 2019 using a prospective database. Preoperative behavioural management included intentional weight loss. Maximum preoperative weight, weight on the day of operation, and Obesity-Surgery Mortality Risk Score (OS-MRS) class were recorded. Short-term outcomes (post-operative stay, 30-day complication and reoperation rates) were analysed. RESULTS: In 2,067 RYGB patients (1,901 primary and 166 revisional), median preoperative total body weight loss (TWL) was 6.2% (IQR: 2.5-10.7%). The median age was 46 (interquartile range (IQR) 38-54) and 80.4% were female (n=1,661). For primary surgery, the median body mass index (BMI) was 47.6 kg/m2 (IQR: 43.1-53.3). Excluding the 100-procedure learning curve, the complication rate for primary cases was 4.4% and reoperation rate of 2.8% and one peri-operative mortality (0.06%). OS-MRS ≥2 (class B or C) predicted higher risk of complications (6.1%) compared to those with a score <2 (class A) (3.8%, p=0.021), but not reoperations. Five percent preoperative TWL did not decrease complications compared to <5% TWL. Patients with ≥10% TWL had greater baseline risk and had an increased risk of complications (6.6% vs 3.7%, p=0.017) and reoperations (4.5% vs 2.7%, p<0.001). CONCLUSIONS: RYGB performed using a standardised technique has low overall risk. The influence of preoperative weight loss on outcomes was inconsistent.

Laparoscopic-Assisted Endoscopic Retrograde Cholangiopancreatography (ERCP) for Bile Duct Stones After Roux-en-Y-Gastric Bypass: Single-Centre Experience.

PURPOSE: Gallstones are common in bariatric patients due to obesity and rapid weight loss. Bile duct stones after Roux-en-Y gastric bypass (RYGB) pose a technical challenge. We present our experience in management of bile duct stones following RYGB using laparoscopic-assisted endoscopic retrograde cholangiopancreatography (LA-ERCP). MATERIALS AND METHODS: Retrospective review of RYGB patients who had endoscopic intervention for bile duct stones between 2010 and 2019. We assessed demographic and clinical outcomes. RESULTS: There were 12 patients: 9 females, median age 64 years (range 34-73), median ASA score 3 (range 2-3), and median body mass index (BMI) 30 kg/m2 (range 24.4-46). Median time of presentation since RYGB was 5 years (range 6-96 months). Clinical presentations were biliary pain with deranged liver function tests (n = 8, 67%) and cholangitis (n = 4, 33%). Ten patients (83%) had cholecystectomy prior to presentation. LA-ERCP was performed in all 12 patients. It was successful in 10 patients (83%) of which 7 were performed as a primary intervention for bile duct stones and 3 were for residual stones following previous bile duct exploration. Two out of 12 LA-ERCPs (17%) were converted to open duct clearance. Median overall hospital stay was 2.5 days (range 1-10). One patient developed post-ERCP pancreatitis; one had chronic pain. There was no major complication or mortality. CONCLUSION: LA-ERCP is feasible for bile duct stones after RYGB and can clear the duct primarily or following previous surgical exploration. It also provides an opportunity to perform cholecystectomy and diagnostic laparoscopy.

Influence of social deprivation on provision of bariatric surgery: 10-year comparative ecological study between two UK specialist centres.

OBJECTIVE: To investigate the effect of residential location and socioeconomic deprivation on the provision of bariatric surgery. DESIGN: Retrospective cross-sectional ecological study. SETTING: Patients resident local to one of two specialist bariatric units, in different regions of the UK, who received obesity surgery between 2003 and 2013. METHODS: Demographic data were collected from prospectively collected databases. Index of Multiple Deprivation (IMD 2010) was used as a measure of socioeconomic status. Obesity prevalences were obtained from Public Health England (2006). Patients were split into three IMD tertiles (high, median, low) and also tertiles of time. A generalised linear model was generated for each time period to investigate the effect of socioeconomic deprivation on the relationship between bariatric case count and prevalence of obesity. We used these to estimate surgical intervention provided in each population in each period at differing levels of deprivation. RESULTS: Data were included from 1163 bariatric cases (centre 1-414, centre 2-749). Incidence rate ratios (IRRs) were calculated to measure the associations between predictor and response variables. Associations were highly non-linear and changed over the 10-year study period. In general, the relationship between surgical case volume and obesity prevalence has weakened over time, with high volumes becoming less associated with prevalence of obesity. DISCUSSION: As bariatric services have matured, the associations between demand and supply factors have changed. Socioeconomic deprivation is not apparently a barrier to service provision more recently, but the positive relationships between obesity and surgical volume we would expect to find are absent. This suggests that interventions are not being taken up in the areas of need. We recommend a more detailed national analysis of the relationship between supply side and demand side factors in the provision of bariatric surgery.

The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase.

BACKGROUND: The prevalence of severe and complex obesity is increasing worldwide and surgery may offer an effective and lasting treatment. Laparoscopic adjustable gastric band and Roux-en-Y gastric bypass surgery are the two main surgical procedures performed. DESIGN: This open parallel-group randomised controlled trial will compare the effectiveness, cost-effectiveness and acceptability of gastric band (Band) versus gastric bypass (Bypass) in adults with severe and complex obesity. It has an internal pilot phase (in two centres) with integrated qualitative research to establish effective and optimal methods for recruitment. Adults with a body mass index (BMI) of 40 kg/m2 or more, or a BMI of 35 kg/m2 or more and other co-morbidities will be recruited. At the end of the internal pilot the study will expand into more centres if the pre-set progression criteria of numbers and rates of eligible patients screened and randomised are met and if the expected rates of retention and adherence to treatment allocation are achieved. The trial will test the joint hypotheses that Bypass is non-inferior to Band with respect to more than 50% excess weight loss and that Bypass is superior to Band with respect to health related quality of life (HRQOL, EQ-5D) at three years. Secondary outcomes include other weight loss measures, waist circumference and remission/resolution of co-morbidities; generic and symptom-specific HRQOL; nutritional blood test results; resource use; eating behaviours and adverse events. A core outcome set for reporting the results of obesity surgery will be developed and a systematic review of the evidence for sleeve gastrectomy undertaken to inform the main study design. DISCUSSION: By-Band is the first pragmatic study to compare the two most commonly performed bariatric surgical procedures for severe and complex obesity. The design will enable and empower surgeons to learn to recruit and participate in a randomised study. Early evidence shows that timely recruitment is possible. TRIAL REGISTRATION: Current Controlled Trials ISRCTN00786323.

Assuring complete laparoscopic clearance of the bile duct.

BACKGROUND: The aim of this study was to evaluate and compare the use of choledochoscopy, cholangiography, and laparoscopic ultrasound in ensuring bile duct clearance and the prevention of missed stones after laparoscopic exploration. METHODS: Operative details of 439 consecutive patients who underwent laparoscopic bile duct exploration between April 1994 and February 2005 were collected prospectively. Thirty-six conversions, 8 failures, and 8 patients who had a biliary enteric drainage procedure were excluded. Follow-up was by postal questionnaire or via their GP if there was no response. RESULTS: One-year follow-up was complete in 95%. Patients underwent 253 transductal, 94 transcystic, and 29 radiological explorations. Laparoscopic ultrasound prompted immediate re-exploration of the bile ducts in six patients for stones missed by choledochoscopy. About 3.4% of patients presented with a missed stone within 1 year of surgery. The negative predictive values of choledochoscopy alone, choledochoscopy followed by postexploratory cholangiography and choledochoscopy followed by postexploratory laparoscopic ultrasound have been found to be 94.6%, 97.9%, and 97.4%, respectively. CONCLUSION: Double checking duct clearance with laparoscopic ultrasound after choledochoscopy is worthwhile, whereas cholangiography is not.

A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis.

INTRODUCTION: Outcomes after endoscopic sphincterotomy (ES) and subsequent laparoscopic cholecystectomy (LC) versus laparoscopic bile duct exploration (LBDE) during LC are comparable in fit patients with choledocholithiasis. This randomized, clinical trial aimed to determine the optimum treatment in patients with higher medical risk. MATERIALS AND METHODS: Ninety-one higher risk patients with evidence of bile duct stones were randomized to ES/LC (group A) or LBDE during LC (group B). The primary outcome measure was duct clearance. Secondary outcome measures were complications, number of procedures per patient, conversion, and postoperative hospital stay (POS). RESULTS: Forty-seven patients were randomized to ES/LC and 44 to LBDE. The median age was 74.56 years. On an intention-to-treat basis, duct clearance was achieved in 29 of 47 of group A and 44 of 44 of Group B patients (P < 0.001). Clavien Grade II-V complications occurred in 8 of 47 and 8 of 44 patients (P = 0.884), the median number of procedures was 2 (2-3) and 1 (1-1) (P < 0.001), 2 of 47 and 4 of 44 patients required conversion (P = 0.676), and the median POS was 3 (2-7) and 5 (2-7) days (P = 0.825), respectively. CONCLUSIONS: There was no difference between approaches to duct clearance in terms of postoperative stay, complications, or conversion in higher risk patients, but the laparoscopic approach was more effective and efficient and avoided unnecessary procedures.

Effect of fluid irrigation on core body temperature during laparoscopic common bile duct exploration.

BACKGROUND: Laparoscopic common bile duct exploration uses large volumes of intraperitoneal irrigation fluid. Much of this fluid crosses the peritoneal cavity. This study was performed to examine its effect on core body temperature. MATERIALS AND METHODS: Ten patients undergoing laparoscopic bile duct exploration were studied. Core temperature was measured intraoperatively. Patients were covered with a warming blanket. The volume of fluid irrigated, carbon dioxide used, and intravenous fluid infused were recorded. Ten patients having cholecystectomy alone were studied as a control group. RESULTS: There was a small but significant rise in core temperature in both the study (P = 0.010) and control (P = 0.002) groups. There was no significant difference in the change in core temperature between the groups (P = 0.706).The mean volume of irrigation fluid used was 2640 mL in the study group and 915 mL in the control group. Mean gas volume used was 162.9 L and 73.3 L and the volume of intravenous fluid infused was 1620 mL and 1190 mL in the study and control groups, respectively. CONCLUSION: The use of large volumes of irrigation fluid during laparoscopic bile duct exploration does not cause a fall in core temperature.