Unexplained abdominal pain in morbidly obese patients after bariatric surgery.

BACKGROUND: There is an overall complication rate of 6.3%-10% after bariatric surgery. After ruling out anatomic/physical causes, there is a substantial group of patients who develop unexplained postsurgical abdominal pain. OBJECTIVES: To inventory the prevalence of unexplained abdominal pain after laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy and to determine predictive factors for unexplained abdominal pain. SETTING: Obesity Center Amsterdam, Amsterdam, the Netherlands. METHODS: A retrospective study in a prospective database was performed. Baseline characteristics and postoperative course were evaluated. RESULTS: A total of 1788 patients underwent laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy between November 2007 and April 2015. The average follow-up consisted of 33.5 months, without loss to follow-up. Abdominal pain was presented in 387 patients (21.6%). The study population consisted of 337 women (87.1%) and 50 men (12.9%); the mean age was 43.3 years (standard deviation 10.1) and the median preoperative body mass index was 43.7 kg/m². An explanation for abdominal pain was found in 246 of 387 patients (63.6%), whereas no explanation was found in 133 patients (34.4%). Revisional surgery was a significant predictor for unexplained pain (odds ratio 1.7; confidence interval 1.0-2.8; P = 0.037). CONCLUSION: A total of 133 patients (7.4%) experienced unexplained abdominal pain after laparoscopic bariatric surgery. Revisional surgery was found to be a significant predictive factor for this outcome. Present study results suggest that postoperative unexplained abdominal pain is a significant morbidity and should be part of the informed consent. More research is needed regarding further diagnosis and management and treatment.

Predicting postoperative complications after bariatric surgery: the Bariatric Surgery Index for Complications, BASIC.

BACKGROUND: Around 20% of bariatric surgery patients develop a short- or long-term complication. OBJECTIVE: Aim of this study was to develop a risk model predicting complications: the Bariatric Surgery Index for Complications (BASIC). SETTING: The Obesity Center Amsterdam, located in a large teaching hospital, in Amsterdam, The Netherlands. METHODS: A prospective consecutive database including patients operated between November 2007 and February 2015 was used. For the BASIC, analysis according to the TRIPOD statement was performed to identify risk factors for complications. Class I included patients with zero to one risk factor, class II patients with two risk factors, and class III patients with three or more risk factors. RESULTS: Of 1709 analyzed patients, mean age was 45 years (±SD 10.7), 1393 (81.5%) were female; mean body mass index was 44.5 kg/m2 (6.8). Overall, 271 (15.9%) patients developed a complication of which 197 (72.5%) occurred within 30 days. Predictors in multivariable analysis were use of anticoagulants (odd's ratio (OR) 1.5); chronic obstructive pulmonary disease (OR 2.3); dyslipidemia (OR 1.4); gender (OR 1.4); psychiatric history (OR 1.3); and revisional surgery (OR 1.5). In class I, 13.5% (181 out of 1338) experienced complications, in class II 58 (21.6%) of the 269 patients and in class III 32 (31.4%) of the 102 patients, respectively. There was a significant difference (p < 0.001) in both overall and 30 day complications. CONCLUSION: The BASIC uses six preoperative variables to classify patients in a low-, intermediate-, or high-risk group for postoperative complications after bariatric surgery.

Evaluation of the obesity surgery mortality risk score for the prediction of postoperative complications after primary and revisional laparoscopic Roux-en-Y gastric bypass.

BACKGROUND: The Obesity Surgery Mortality Risk Score (OS-MRS) is a validated instrument for mortality risk prediction in patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures classifying patients into low risk (class A), intermediate risk (class B), and high risk (class C). OBJECTIVES: The primary aim of this study was to evaluate the accuracy of the OS-MRS in predicting postoperative complications after LRYGB. Secondarily, the postoperative complication rate between primary and revisional LRYGB was systematically analyzed. SETTING: The Obesity Center Amsterdam, located in a large teaching hospital, in Amsterdam, The Netherlands. METHODS: The OS-MRS was applied to a consecutive database of patients who underwent LRYGB from November 2007 onwards. Postoperative complications were scored according to the Clavien-Dindo classification. Revisional LRYGB was separately analyzed. RESULTS: LRYGB was performed in 1667 patients either as a primary (81.5%) or revisional (18.5%) procedure. The majority (n = 1371, 82.2%) were female, mean age 44.6 (standard deviation 14.4) years and mean body mass index 44.2 (6.5) kg/m2. Nine hundred and four (54.2%) were OS-MRS class A, 642 class B (38.5%), and 121 (7.3%) class C. Complications occurred in 143 (10.5%) and 44 (14.2%) patients after primary and revisional surgery, respectively. In both primary and revisional LRYGB, there was no association between complications and the OS-MRS classification. Subanalysis comparing primary with revisional LRYGB found a significant association between revisional surgery and the development of severe complications (Clavien-Dindo≥3) (P = .003) and mortality (P = .017). CONCLUSION: The OS-MRS was not an accurate predictor for postoperative complications in patients who underwent primary or revisional LRYGB. As in other studies, revisional surgery is an independent risk factor for the development of severe complications.

The influence of prophylactic proton pump inhibitor treatment on the development of symptomatic marginal ulceration in Roux-en-Y gastric bypass patients: a historic cohort study.

BACKGROUND: Marginal ulceration at the gastrojejunostomy is a serious complication after laparoscopic Roux-en-Y gastric bypass surgery (LRYGB) and occurs in 1%-16% of patients. Proton pump inhibitors (PPIs) might lower the occurrence of these ulcers. OBJECTIVES: The aim of the present study was to evaluate the effect of 6 months prophylactic usage of PPIs on the development of marginal ulceration and compare this with a historic patient control group. SETTING: A single institution cohort at a bariatric center of excellence, The Sint Lucas Andreas Zienkenhuis, Amsterdam METHODS: A consecutive database of patients who underwent LRYGB from November 2007 to September 2012 in a single institution was retrospectively reviewed. From August 2011, patients received a standard dose of pantozol 40 mg once daily directly postoperatively for 6 months. No standard PPI prophylaxis was administered before August 2011, and the patients not using PPIs in this historic cohort served as the control group. RESULTS: A total of 610 patients underwent LRYGB, of which 128 patients (21.0%) underwent revisional surgery. Postoperative PPIs were administered in the intervention group of 337 patients, compared with the historic control group consisting of 273 patients. Six patients (1.2%) who received postoperative PPIs versus 20 patients (7.3 %) in the historic control group developed marginal ulceration (P = .001). Patients using proton pump inhibitors developed fewer gastrointestinal complaints postoperatively (P< .001). CONCLUSIONS: Routine usage of PPIs reduced the occurrence of marginal ulceration after LRYGB.

Trocar Port Hernias After Bariatric Surgery.

BACKGROUND: Laparoscopic bariatric surgery is increasingly being performed worldwide. It is estimated that trocar port hernias occur more often in obese patients due to their obesity and because the ports are not closed routinely. The aim of the present study was to analyze the incidence, risk factors, and management of patients with trocar port hernias after laparoscopic bariatric surgery. METHODS: All patients who were operated between 2006 and 2013 were included. During the study period, the trocar ports were not closed routinely. All patients who had any symptomatic abdominal wall hernia during follow-up were included. RESULTS: Overall, 1524 laparoscopic bariatric procedures were performed. There were 1249 female (82 %) and 275 male (18 %) patients. The mean age was 44 years, and median body mass index was 43 kg/m(2). Patients underwent laparoscopic Roux-en-Y gastric bypass (LRYGB) (n = 859), laparoscopic adjustable gastric banding (LAGB) (n = 364), laparoscopic sleeve gastrectomy (LSG) (n = 68), revisional surgery (n = 226), and other procedures (n = 7). Three hundred and one patients (20 %) had one or more postoperative complications and the overall mortality was 0.3 % (four patients). There were 14 patients (0.9 %) with an abdominal wall hernia, of which eight (0.5 %) had a trocar port hernia, three (0.2 %) an incisional hernia from other previous surgery, and three (0.2 %) an umbilical hernia. Gender, age, BMI, smoking, type II diabetes, procedure type, complications, and weight loss were not associated with the occurrence of abdominal wall hernias. CONCLUSIONS: Trocar port hernias after bariatric surgery occur seldom if the trocar port is not routinely closed.

Predictive Factors for Insufficient Weight Loss After Bariatric Surgery: Does Obstructive Sleep Apnea Influence Weight Loss?

BACKGROUND: Important endpoints of bariatric surgery are weight loss and improvement of comorbidities, of which obstructive sleep apnea (OSA) is the highest accompanying comorbidity (70%). This study aimed to evaluate the influence of OSA on weight loss after bariatric surgery and to provide predictive factors for insufficient weight loss (defined as ≤50% excess weight loss (EWL)) at 1 year follow-up. METHODS: All consecutive patients, who underwent primary laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy between 2006 and 2014 were retrospectively reviewed. Patients with data on preoperative apnea-hypopnea index (AHI) and pre- and postoperative body mass index (BMI) were included. After surgery, the percentage excess weight loss (%EWL) and BMI changes were compared between preoperatively diagnosed OSA-, subdivided in mild, moderate, and severe OSA, and non-OSA patients. Multivariable logistic regression analysis evaluated predictive factors for ≤50% EWL. RESULTS: A total of 816 patients, 522 (64%) with and 294 (36%) without OSA, were included. After 1 year, OSA patients achieved less %EWL than non-OSA patients (65.5 SD 20.7 versus 70.3 SD 21.0; p < 0.01). The lowest %EWL was seen in severe OSA patients (61.7 SD 20.2). However, when adjusted for waist circumference, BMI, and age, no effect of OSA was seen on %EWL or changes in BMI. Although AHI, gender, age, BMI, type of surgery, and type II diabetes were predictive factors for ≤50% EWL (area under the curve 0.778), the AHI as variable was of little importance. CONCLUSIONS: The presence of OSA does not individually impair weight loss after bariatric surgery.

Improving care after colon cancer treatment in The Netherlands, personalised care to enhance quality of life (I CARE study): study protocol for a randomised controlled trial.

BACKGROUND: It is expected that in 2020 more than 17,000 cases of colorectal cancer will be diagnosed in The Netherlands. To date, patients are included in a surgeon-led follow-up programme whose main focus is recurrence detection. However, patients often experience multiple physical and psychosocial problems. Currently, these problems are not always encountered. More care by a generalist is suggested as a solution. Furthermore, patients prefer to undergo rehabilitation in their own environment and to be more involved in their own health care. eHealth applications might enhance this. Oncokompas(2.0) is an online self-management application which facilitates access to supportive care. This study aims to evaluate primary care follow-up and aftercare in comparison with secondary care follow-up and aftercare for patients with colon cancer. Second, the added value of Oncokompas(2.0) to care will be assessed. METHODS/DESIGN: This is a multi-centre 2 × 2 factorial randomised controlled trial with a calculated sample size of 300 patients. Patients with stage I, II, or III colon carcinoma are eligible. Patients will be randomly assigned in four groups: (1) usual follow-up visits and aftercare provided in secondary care, (2) usual follow-up visits and aftercare provided in secondary care with additional use of Oncokompas(2.0), (3) follow-up and aftercare in primary care, and (4) follow-up and aftercare in primary care with additional use of Oncokompas(2.0). The primary outcome is quality of life. Secondary outcomes include physical outcomes, psychosocial outcomes, number of investigations, referrals and related communication between secondary and primary care, (time of) recurrence detection and protocol adherence, attention to preventive care, self-management of patients, patient satisfaction, and preference of care at the end of the trial. Data collection will be done by questionnaires and extractions from electronic medical records. DISCUSSION: The results of this study will provide evidence, which has been scarce to date, on prominent general practitioner involvement in care for colon cancer patients after initial treatment. Also, it evaluates the efficacy of an eHealth application to enhance patient empowerment. DUTCH TRIAL REGISTER: NTR4860 (registered on 2 October 2014).

Lymph Node Yield in Colon Cancer: Individuals Can Make the Difference.

AIM: To investigate the influence of individual surgeons and pathologists on examining an adequate (i.e. ≥10) number of lymph nodes in colon cancer resection specimens. PATIENTS AND METHODS: The number of lymph nodes was evaluated in surgically treated patients for colon cancer at our hospital from 2008 through 2010, excluding patients who had received neo-adjuvant treatment. The patient group consisted of 156 patients with a median age of 73 (interquartile range (IQR) 63-82 years) and a median of 12 lymph nodes per patient (IQR 8-15). In 106 patients (67.9%), 10 or more nodes were histopathologically examined. RESULTS: At univariate analysis, the examination of ≥10 nodes was influenced by tumour size (p = 0.05), tumour location (p = 0.015), type of resection (p = 0.034), individual surgeon (p = 0.023), and pathologist (p = 0.005). Neither individual surgeons nor pathologists did statistically and significantly influence the chance of finding an N+ status. Age (p = 0.044), type of resection (p = 0.007), individual surgeon (p = 0.012) and pathologist (p = 0.004) were independent prognostic factors in a multivariate model for finding ≥10 nodes. CONCLUSION: Though cancer staging was not affected in this study, individual efforts by surgeons and pathologists play a critical role in achieving optimal lymph node yield through conventional methods.

The anal fistula plug treatment compared with the mucosal advancement flap for cryptoglandular high transsphincteric perianal fistula: a double-blinded multicenter randomized trial.

BACKGROUND: The anal fistula plug was developed as an alternative treatment for perianal fistulas. OBJECTIVE: This study aimed to compare the anal fistula plug with the mucosal advancement flap for the treatment of high transsphincteric fistulas. DESIGN: This study was a double-blinded, multicenter, randomized trial. PATIENTS: Sixty patients with perianal fistulas were randomly assigned to receive an anal fistula plug or a mucosal advancement flap and were blinded for the type of treatment. MAIN OUTCOME MEASURES: The outcome measures comprised the closure rate, postoperative pain, continence (colorectal functional outcome, Vaizey, and Wexner scores), and quality of life. Closure was determined by clinical examination by a surgeon blinded for the intervention. RESULTS: At a follow-up of 11 months the recurrence rates were 71% (n = 22) in the anal fistula plug group and 52% (n = 15) in the mucosal advancement flap group, which was not significantly different. There were no significant differences in postoperative pain, in pre- and postoperative incontinence scores, soiling, and quality of life. CONCLUSIONS: The results of the anal fistula plug and advancement flap procedures are disappointing in the multicenter setting. There were no significant differences in recurrence, functional outcome, and quality of life between the plug and the advancement flap. Because the plug is simple to apply and minimally invasive, it can be considered as an initial treatment option for high transsphincteric fistulas.

[Effects of bariatric surgery not affected by psychiatric comorbidity: a systematic review of studies of morbidly obese patients]. / Psychiatrische stoornis beïnvloedt het effect van bariatrische chirurgie niet: een systematische review van onderzoek bij morbide obese patiënten.

OBJECTIVE: To review the literature on the predictive value of psychiatric comorbidity for weight loss following bariatric surgery in patients with morbid obesity. DESIGN: Systematic review. METHOD: PubMed databases were searched for literature comparing weight loss following bariatric surgery in morbidly obese patients with and without preoperative psychiatric symptoms. General psychiatric disorders were distinguished from eating disorders. RESULTS: The search yielded 204 references, 6 of which complied with inclusion criteria. 2 studies were retrospective (169 patients in total; the other 4 were prospective (1140 patients in total). The average follow-up period varied between 12 and 60 months. In 2 studies (n = 528 patients), the influence of eating disorders on the outcome of bariatric surgery was specifically studied. The quality of the studies was low. Psychiatric disorders and eating disorders did not influence the outcome of bariatric surgery. In 1 study, weight loss was less after surgery in patients diagnosed with more than 2 psychiatric disorders. CONCLUSION: In 5 of the 6 studies, psychiatric comorbidity was not related to the weight loss following bariatric surgery. In view of the differences in design and the poor quality of the studies, definite conclusions cannot be drawn. There is no indication that routine psychiatric screening should form part of the work-up for bariatric surgery. We advise that note should be taken of the psychiatric history and any current psychiatric treatment.

[Colonic obstruction due to volvulus of the sigmoid colon or caecum]. / Colon-obstructie door volvulus van sigmoïd of caecum.

3 patients, 2 women aged 41 and 47 and one man aged 75 years, presented with abdominal pain and distension. In 2 patients the diagnosis 'sigmoid volvulus' was reached following plain abdominal X-ray. Both patients underwent sigmoidal resection with primary anastomosis after endoscopic deflation. The third patient proved to have a caecal volvulus on emergency laparotomy and underwent ileocaecal resection. In 2/3 of the cases diagnosis can be made by history, physical examination and conventional X-ray. Delay in the diagnosis increases the risk of peritonitis and death due to ischaemia and perforation of the colon. In the absence of peritoneal tenderness, signs of ischaemia or sepsis, the initial treatment consists of endoscopic deflation, which is successful in 68-78% of cases. Resection of the sigmoid colon is recommended a few days after endoscopic decompression in order to prevent recurrence. Caecal volvulus is not suitable for treatment with endoscopic deflation and should be treated with ileocaecal resection.

The anal fistula plug versus the mucosal advancement flap for the treatment of anorectal fistula (PLUG trial).

BACKGROUND: Low transsphincteric fistulas less than 1/3 of the sphincter complex are easy to treat by fistulotomy with a high success rate. High transsphincteric fistulas remain a surgical challenge. Various surgical procedures are available, but recurrence rates of these techniques are disappointingly high. The mucosal flap advancement is considered the gold standard for the treatment of high perianal fistula of cryptoglandular origin by most colorectal surgeons. In the literature a recurrence rate between 0 and 63% is reported for the mucosal flap advancement. Recently Armstrong and colleagues reported on a new biologic anal fistula plug, a bioabsorbable xenograft made of lyophilized porcine intestinal submucosa. Their prospective series of 15 patients with high perianal fistula treated with the anal fistula plug showed promising results. The anal fistula plug trial is designed to compare the anal fistula plug with the mucosal flap advancement in the treatment of high perianal fistula in terms of success rate, continence, postoperative pain, and quality of life. METHODS/DESIGN: The PLUG trial is a randomized controlled multicenter trial. Sixty patients with high perianal fistulas of cryptoglandular origin will be randomized to either the fistula plug or the mucosal advancement flap. Study parameters will be anorectal fistula closure-rate, continence, post-operative pain, and quality of life. Patients will be followed-up at two weeks, four weeks, and 16 weeks. At the final follow-up closure rate is determined by clinical examination by a surgeon blinded for the intervention. DISCUSSION: Before broadly implementing the anal fistula plug results of randomized trials using the plug should be awaited. This randomized controlled trial comparing the anal fistula plug and the mucosal advancement flap should provide evidence regarding the effectiveness of the anal fistula plug in the treatment of high perianal fistulas. TRIAL REGISTRATION: ISRCTN: 97376902.

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.

Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial).

BACKGROUND: Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay. The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst track multimodal management versus standard care) was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease. METHODS/DESIGN: The LAFA-trial is a double blinded, multicenter trial with a 2 x 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be randomized to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups; open colectomy with standard care (a), open colectomy with fast track program (b), laparoscopic colectomy with standard care (c), and laparoscopic surgery with fast track program (d). Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days. Secondary outcome parameters are quality of life two and four weeks after surgery, overall hospital costs, morbidity, patient satisfaction and readmission rate. Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the Short Form 36 (SF-36) questionnaire and social functioning can be detected. DISCUSSION: The LAFA-trial is a randomized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in patients having segmental colectomy for malignant disease.

Development and validation of a colorectal functional outcome questionnaire.

BACKGROUND: After colorectal surgery, patients often experience impaired functional outcome. Faecal incontinence grading systems and self-assessment questionnaires are frequently used to assess these complaints. The available faecal incontinence grading systems have been validated, but have a limited focus, while more comprehensive questionnaires, which have been developed, have not been validated. AIMS: To investigate the reliability and validity of a newly developed, colorectal functional outcome (COREFO) questionnaire and of Dutch translations of the Hallböök questionnaire and an adapted version of the Vaizey questionnaire. PATIENT/METHODS: Two hundred fifty-seven patients with and without impaired functional outcome after (colorectal) surgery received a booklet containing the three questionnaires in random order by mail. One hundred seventy-nine (70%) completed them, and 160 patients (90%) completed a retest within, on average, 18 days. RESULTS/FINDINGS: Reliability and validity were adequate for the COREFO and Hallböök questionnaire, with slight differences in the psychometric analyses in favour of the COREFO questionnaire. Significantly more patients found the COREFO questionnaire to reflect their problems best. The reliability of the Vaizey questionnaire was not sufficient. INTERPRETATION/CONCLUSIONS: The newly developed COREFO questionnaire and the previously unvalidated Hallböök questionnaire are both suitable instruments to evaluate functional outcome after colorectal surgery. The psychometric analyses showed a slight difference in favour of the COREFO questionnaire and significantly more patients preferred the COREFO questionnaire to the other questionnaires. Therefore, we prefer to use the COREFO questionnaire in future research.