Consistency of patient-reported outcomes after cholecystectomy and their implications on current surgical practice: a prospective multicenter cohort study.

BACKGROUND: Persistent postoperative pain (up to 41 %) and significant practice variation necessitate better patient selection for cholecystectomy. Patient-reported outcome measures (PROMs) are nowadays known to serve as a tool for better patient selection, although variability within these subjective outcomes may be a point for debate. This study determines associations of both the preoperative pain and patient characteristics with PROMs at 24 weeks after cholecystectomy. In order to evaluate variability of PROMs, we also determined consistency of these outcomes in time. METHODS: This prospective multicenter cohort study included adult patients diagnosed with uncomplicated symptomatic cholecystolithiasis. Twenty-four weeks after surgery, a questionnaire study was carried out, containing Gastrointestinal Quality of Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire. Results were compared to preoperative data and results 12 weeks post-cholecystectomy. Logistic regression analyses were performed to determine associations. Additional post hoc analysis on associations between preoperative selection criteria and PROMs was done. RESULTS: A total of 360 patients (85 %) responded. Postoperative absence of pain was reported by 59.2 %. Associated characteristics were symptoms ≤1 year prior to surgery [OR 1.85 (95 % CI 1.11-3.09)] and high baseline GIQLI score [OR 1.04 (95 % CI 1.02-1.05)]. General improvement in abdominal symptoms and positive result of surgery were found in 90 %; no preoperative variables were significantly associated. PROMs showed consistency at 12 and 24 weeks postoperatively. Post hoc analysis showed no significant associations. CONCLUSION: PROM-based preoperative selection criteria need to be considered to select those patients who achieve freedom of pain after surgical treatment of uncomplicated symptomatic cholecystolithiasis. Other patients might consider cholecystectomy as successful, but are less likely to be free of pain. Usefulness of PROMs is underscored as they proved to be consistent in time in evaluating surgical outcome.

Episodic Abdominal Pain Characteristics Are Not Associated with Clinically Relevant Improvement of Health Status After Cholecystectomy.

BACKGROUND: Cholecystectomy is the therapy of first choice in patients with uncomplicated symptomatic cholecystolithiasis, but it remains unclear which patients truly benefit in terms of health status improvement. Patients generally present with episodic abdominal pain of varying frequency, duration, and intensity. We assessed whether characteristics of abdominal pain episodes are determinants of clinically relevant improvement of health status after cholecystectomy. METHODS: In a post hoc analysis of a prospective multicenter cohort study, patients of ≥18 years of age with uncomplicated symptomatic cholecystolithiasis subjected to cholecystectomy were included. Preoperatively, patients received a structured interview and a questionnaire consisting of the visual analogue scale (VAS; range 0-100) and gastrointestinal quality of life index (GIQLI). At 12 weeks after cholecystectomy, the GIQLI was again administered. Logistic regression analyses were performed to determine significant associations. RESULTS: Questionnaires were sent to 261 and returned by 166 (63.6 %) patients (128 females, mean age at surgery 49.5 ± 13.8). A total of 131 (78.9 %) patients reported a clinically relevant improvement of health status. The median (interquartile range) frequency, duration, and intensity of abdominal pain episodes were 0.38 (0.18-0.75) a week, 4.00 (2.00-8.00) hours, and 92 (77-99), respectively. None of the characteristics was associated with a clinically relevant improvement of health status at 12 weeks after cholecystectomy. CONCLUSIONS: Characteristics of abdominal pain episodes cannot be used to inform patients with symptomatic cholecystolithiasis who are skeptic about the timing of cholecystectomy for optimal benefit. Timing of cholecystectomy should therefore be based on other characteristics and preferences.

Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial.

BACKGROUND: In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy of interval cholecystectomy. However, evidence to support same-admission cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare same-admission and interval cholecystectomy, with the hypothesis that same-admission cholecystectomy would reduce the risk of recurrent gallstone-related complications without increasing the difficulty of surgery. METHODS: For this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, inpatients recovering from mild gallstone pancreatitis at 23 hospitals in the Netherlands (with hospital discharge foreseen within 48 h) were assessed for eligibility. Adult patients (aged ≥18 years) were eligible for randomisation if they had a serum C-reactive protein concentration less than 100 mg/L, no need for opioid analgesics, and could tolerate a normal oral diet. Patients with American Society of Anesthesiologists (ASA) class III physical status who were older than 75 years of age, all ASA class IV patients, those with chronic pancreatitis, and those with ongoing alcohol misuse were excluded. A central study coordinator randomly assigned eligible patients (1:1) by computer-based randomisation, with varying block sizes of two and four patients, to cholecystectomy within 3 days of randomisation (same-admission cholecystectomy) or to discharge and cholecystectomy 25-30 days after randomisation (interval cholecystectomy). Randomisation was stratified by centre and by whether or not endoscopic sphincterotomy had been done. Neither investigators nor participants were masked to group assignment. The primary endpoint was a composite of readmission for recurrent gallstone-related complications (pancreatitis, cholangitis, cholecystitis, choledocholithiasis needing endoscopic intervention, or gallstone colic) or mortality within 6 months after randomisation, analysed by intention to treat. The trial was designed to reduce the incidence of the primary endpoint from 8% in the interval group to 1% in the same-admission group. Safety endpoints included bile duct leakage and other complications necessitating re-intervention. This trial is registered with Current Controlled Trials, number ISRCTN72764151, and is complete. FINDINGS: Between Dec 22, 2010, and Aug 19, 2013, 266 inpatients from 23 hospitals in the Netherlands were randomly assigned to interval cholecystectomy (n=137) or same-admission cholecystectomy (n=129). One patient from each group was excluded from the final analyses, because of an incorrect diagnosis of pancreatitis in one patient (in the interval group) and discontinued follow-up in the other (in the same-admission group). The primary endpoint occurred in 23 (17%) of 136 patients in the interval group and in six (5%) of 128 patients in the same-admission group (risk ratio 0·28, 95% CI 0·12-0·66; p=0·002). Safety endpoints occurred in four patients: one case of bile duct leakage and one case of postoperative bleeding in each group. All of these were serious adverse events and were judged to be treatment related, but none led to death. INTERPRETATION: Compared with interval cholecystectomy, same-admission cholecystectomy reduced the rate of recurrent gallstone-related complications in patients with mild gallstone pancreatitis, with a very low risk of cholecystectomy-related complications. FUNDING: Dutch Digestive Disease Foundation.

Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial.

BACKGROUND: After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. METHODS/DESIGN: PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy), and uncomplicated biliary colics) occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. DISCUSSION: The PONCHO trial is designed to show that early laparoscopic cholecystectomy (within 72 hours) reduces the combined endpoint of mortality and re-admissions for biliary events as compared with interval laparoscopic cholecystectomy (between 25 and 30 days) after recovery of a first episode of mild biliary pancreatitis. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN72764151.

Long-term results of the cut-closed-reconnected Roux loop for enterogastric reflux.

BACKGROUND: The aim of this study was to present the long-term results of the cut-closed-reconnected (CCR)-Roux procedure for reflux gastritis. METHODS: A retrospective analysis was performed on 14 patients with proven reflux gastritis and/or esophagitis who were treated at our institution with a CCR-Roux procedure between 1992 and 1997. RESULTS: The closure of the afferent loop in the CCR-Roux procedure is effective and permanent. The CCR-Roux patients did not need a rest gastrectomy. No signs of Roux stasis syndrome were seen. There was a consistent weight gain at 2 and 5 years of follow-up. These results permit a comparison with those of the Roux-Y procedure and other alternative procedures as well. CONCLUSION: In the long run, the CCR-Roux procedure is effective in the treatment of reflux gastritis.

Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial.

BACKGROUND: Mechanical bowel preparation is a common practice before elective colorectal surgery. We aimed to compare the rate of anastomotic leakage after elective colorectal resections and primary anastomoses between patients who did or did not have mechanical bowel preparation. METHODS: We did a multicentre randomised non-inferiority study at 13 hospitals. We randomly assigned 1431 patients who were going to have elective colorectal surgery to either receive mechanical bowel preparation or not. Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with either polyethylene glycol or sodium phosphate. The primary endpoint was anastomotic leakage, and the study was designed to test the hypothesis that patients who are given mechanical bowel preparation before colorectal surgery do not have a lower risk of anastomotic leakage than those who are not. The median follow-up was 24 days (IQR 17-34). We analysed patients who were treated as per protocol. This study is registered with ClinicalTrials.gov, number NCT00288496. FINDINGS: 77 patients were excluded: 46 who did not have a bowel resection; 21 because of missing outcome data; and 10 who withdrew, cancelled, or were excluded for other reasons. The rate of anastomotic leakage did not differ between both groups: 32/670 (4.8%) patients who had mechanical bowel preparation and 37/684 (5.4%) in those who did not (difference 0.6%, 95% CI -1.7% to 2.9%, p=0.69). Patients who had mechanical bowel preparation had fewer abscesses after anastomotic leakage than those who did not (2/670 [0.3%] vs 17/684 [2.5%], p=0.001). Other septic complications, fascia dehiscence, and mortality did not differ between groups. INTERPRETATION: We advise that mechanical bowel preparation before elective colorectal surgery can safely be abandoned.

Anterior resection of rectal cancer without bowel preparation and diverting stoma.

PURPOSE: Since the introduction of total mesorectal excision (TME) as the standard operation technique for rectal cancer, anastomotic leakage percentages of up to 18% have been reported. To prevent such leakage, the use of mechanical bowel preparation and also the construction of a diverting ileostoma or colostomy have been standard procedures for years. In our institute, however, all patients undergoing colorectal surgery are operated upon without these measures. The present study was undertaken to investigate the results of this strategy in terms of the occurrence of postoperative anastomotic leakage. METHODS: All patients who underwent an elective (low) anterior resection between January 1996 and December 2001 (n = 144) entered the study. The clinical and pathological records of these patients were reviewed retrospectively. The exclusion criteria were patients with fixed rectal carcinoma who received preoperative radiotherapy and/or a stoma only at operation, emergency operations, abdominoperoneal resections, and Hartmann's procedures. RESULTS: Anastomotic leakage occurred in 7 out of 144 patients (4.9%). There was a trend toward a higher leakage frequency in men, in patients with a distal anastomosis, in patients with a stapled anastomosis, and in patients with a T3-T4 tumor or with positive lymph nodes. None of these factors, however, had a significant prognostic value based on a univariate or multivariate analysis. Those who died after leakage tended to be older than those who did not (P < 0.05). CONCLUSION: A (low) anterior resection can be performed safely without mechanical bowel preparation or a diverting stoma, and results in an anastomotic leakage percentage of less than 5%. Appropriate selection of patients may be important, but none of the investigated patient- or tumor-related factors could be identified as decisive.

Local recurrence of rectal cancer after total mesorectal excision without preoperative radiotherapy.

BACKGROUND: At this moment, it is still debatable whether all patients with mobile rectal cancer who undergo surgical removal of the tumor should be treated with preoperative radiotherapy, since it is likely that only certain patients will benefit from this strategy. In this study, patients with mobile rectal cancer were immediately operated upon and only those with positive nodes or with incomplete resection received adjuvant radiotherapy. AIMS OF THE STUDY: To investigate the local recurrence rate after the use of a selective policy of adjuvant radiotherapy and to determine risk factors for local recurrence. METHODS: In a 5-yr-period, 178 patients with rectal cancer were referred to our institute. A total of 131 patients with mobile rectal cancer were treated with curative intent, which implied a microscopically radical resection and no signs of distant metastasis at operation. A retrospective analysis was undertaken to investigate the incidence of local recurrence in this curative group and to determine risk factors for local recurrence. RESULTS: The postoperative mortality in the curative group was 5.3%. Local recurrences were observed in 6 patients (4.6%) after a median period of 25 mo (range 11-37); two of them also had distant metastases detected at the same time. The highest local recurrence rates were seen in men (5.3%), in distal rectal cancers (6.9%), and in the node-positive group (8.7%). CONCLUSION: A low local recurrence rate can be achieved after total mesorectal excision (TME) without preoperative radiotherapy. Our results suggest using preoperative radiotherapy only for those patients who are at a higher risk for local recurrence. Staging techniques for selection of these patients are at this moments till inappropriate.