Bariatric surgery for spontaneous ovulation in women living with polycystic ovary syndrome: the BAMBINI multicentre, open-label, randomised controlled trial.

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. Obesity exacerbates the reproductive complications of PCOS; however, the management of obesity in women with PCOS remains a large unmet clinical need. Observational studies have indicated that bariatric surgery could improve the rates of ovulatory cycles and prospects of fertility; however, the efficacy of surgery on ovulation rates has not yet been compared with behavioural modifications and medical therapy in a randomised trial. The aim of this study was to compare the safety and efficacy of bariatric surgery versus medical care on ovulation rates in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. METHODS: In this multicentre, open-label, randomised controlled trial, 80 women older than 18 years, with a diagnosis of PCOS based on the 2018 international evidence-based guidelines for assessing and managing PCOS, and a BMI of 35 kg/m2 or higher, were recruited from two specialist obesity management centres and via social media. Participants were randomly assigned at a 1:1 ratio to either vertical sleeve gastrectomy or behavioural interventions and medical therapy using a computer-generated random sequence (PLAN procedure in SAS) by an independent researcher not involved with any other aspect of the clinical trial. The median age of the entire cohort was 31 years and 79% of participants were White. The primary outcome was the number of biochemically confirmed ovulatory events over 52 weeks, and was assessed using weekly serum progesterone measurements. The primary endpoint included the intention-to-treat population and safety analyses were per-protocol population. This study is registered with the ISRCTN registry (ISRCTN16668711). FINDINGS: Participants were recruited from Feb 20, 2020 to Feb 1, 2021. 40 participants were assigned to each group and there were seven dropouts in the medical group and ten dropouts in the surgical group. The median number of ovulations was 6 (IQR 3·5-10·0) in the surgical group and 2 (0·0-4·0) in the medical group. Women in the surgical group had 2.5 times more spontaneous ovulations compared with the medical group (incidence rate ratio 2·5 [95% CI 1·5-4·2], p<0·0007). There were more complications in the surgical group than the medical group, although without long-term sequelae. There were 24 (66·7%) adverse events in the surgical group and 12 (30·0%) in the medical group. There were no treatment-related deaths. INTERPRETATION: Bariatric surgery was more effective than medical care for the induction of spontaneous ovulation in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. Bariatric surgery could, therefore, enhance the prospects of spontaneous fertility in this group of women. FUNDING: The Jon Moulton Charity Trust.

Risk Factors for Chronic Abdominal Pain After RYGB: Are Patients Adequately Selected Beforehand?

PURPOSE: Chronic abdominal pain after RYGB is a known issue. Identifying the potential patient-related and modifiable risk factors might contribute to diminish the risk for this undesirable outcome. METHODS: A single-center retrospective cohort study with prospective data collection was conducted with inclusion of all patients who underwent RYGB surgery between 2015 and 2021. Data from the NBSR and medical records were used. Patients with chronic abdominal pain were defined when pain lasting or recurring for more than 3 to 6 months. RESULTS: Six hundred sixty-four patients who underwent RYGB surgery were included with a median follow-up of 60.5 months. Forty-nine patients (7.3%) presented with chronic abdominal pain. Postoperative complications (OR 13.376, p = 0.020) and diagnosis of depression (OR 1.971, p = 0.037) were associated with developing abdominal pain. On the other hand, ex-smokers (OR 0.222, p = 0.040) and older age (0.959, p = 0.004) presented as protective factors. CONCLUSION: Postoperative complications and diagnosis of depression are risk factors for chronic pain after RYGB. The role of the bariatric MDT remains crucial to select these patients adequately beforehand.

Patient perspectives on surgeon-specific outcome reports in bariatric surgery.

BACKGROUND: Surgeon specific outcome reports (SSOR) in the UK can be accessed freely by the general public to promote transparency and informed decision-making. However, the views amongst bariatric patients concerning these data are unknown. OBJECTIVES: The aims of this study were to determine patient awareness, views and priorities for outcome reporting in bariatric surgery, and to provide recommendations for future surgeon-specific outcome reporting through the United Kingdom National Bariatric Surgery Registry. SETTING: Bariatric surgical unit in a UK university teaching hospital. METHODS: We adapted a previously validated questionnaire and surveyed the views of 150 patients in a single bariatric surgical unit. We collected data concerning awareness, views, and future priorities for outcome reporting. RESULTS: A full 73% of participants were unaware they could access SSOR. Of the participants that were unaware, 75% stated that they would have accessed SSOR had they been aware they could. Of the participants that had previously accessed SSOR, 86% stated they understood the data, although 61% indicated it did not influence their choice of surgeon. The majority of participants favored public release of outcome reports at the surgeon-level (75%) and hospital-level (83%). The 3 main priorities indicated by participants for future outcome reporting were complication rates (91%), patient reported outcome measures (90%), and reoperation rate (89%), all at the surgeon level. CONCLUSION: Patient awareness of outcome reporting is poor. Efforts must be made to increase awareness of SSOR. Patients should be incorporated as key stakeholders in determining future outcome reporting in bariatric surgery.

Assurance of surgical quality within multicenter randomized controlled trials for bariatric and metabolic surgery: a systematic review.

BACKGROUND: Surgical quality assurance methods aim to ensure standardization and high quality of surgical techniques within multicenter randomized controlled trials (RCTs), thereby diminishing the heterogeneity of surgery and reducing biases due to surgical variation. This study aimed to establish the measures undertaken to ensure surgical quality within multicenter RCTs investigating bariatric and metabolic surgery, and their influence upon clinical outcomes. METHODS: An electronic literature search was performed from the Embase, Medline, and Web of Science databases to identify multicenter RCTs investigating bariatric and metabolic surgery. Each RCT was evaluated against a checklist of surgical quality measures within 3 domain: (1) standardization of surgical techniques; (2) credentialing of surgical experience; and (3) monitoring of performance. Outcome measures were postoperative weight change and complications. RESULTS: Nineteen multicenter RCTs were included in the analysis. Three studies undertook pretrial education of surgical standard. Fourteen studies described complete standardization of surgical techniques. Four studies credentialed surgeons by case volume prior to enrollment. Two studies used intraoperative or video evaluation of surgical technique prior to enrollment. Only two studies monitored performance during the study. Although there were limited quality assurance methods undertaken, utilization of these techniques was associated with reduced overall complications. Standardization of surgery was associated with reduced re-operation rates but did not influence postoperative weight loss. CONCLUSION: The utilization of methods for surgical quality assurance are very limited within multicenter RCTs of bariatric and metabolic surgery. Future studies must implement surgical quality assurance methods to reduce variability of surgical performance and potential bias within RCTs.

Caecal volvulus: untwisting the mystery.

Caecal volvulus is an infrequent cause of acute surgical abdomen, where an abnormally mobile cecum twists on its own axis. It can lead to the development of closed-loop obstruction, small bowel ischaemia and perforation. Early recognition and prompt treatment is key; however, due to the rarity of this pathology, it is seldom listed as a differential diagnosis. Here, we present a single-centre case series of two patients presenting with caecal volvulus to an Emergency Surgery Unit at a University Hospital.

Citation classics in general medical journals: assessing the quality of evidence; a systematic review.

AIM: This review provides a comprehensive overview of more than 100 of the most cited studies in general medical journals and evaluates whether citations predict the quality of a scientific article. BACKGROUND: The number of citations is commonly used as a measure of the quality and impact of a scientific article. However, it is often criticised that the number of citations is in fact a poor indicator of the true quality, as it can be influenced by different factors such as current trends. METHODS: This review was conducted in line with the PRISMA guidelines. The Journal Citation Report (JCR) within Incites allowed the evaluation and comparison of articles, published in general medical journals, using far-reaching citation data drawn from scholarly and technical journals and conference proceedings. All steps of the review were performed in duplicate and conflicts were resolved through consensus. RESULTS: The 100 most cited articles published from 1963 until the end of 2018 were identified. The number of citations ranged from 4012 to 31853. Most of the articles were published in the 2000's, followed by the 1990's, 1980's, 1970's and 1960's, respectively. All of the articles were published in five journals. There were 50 studies at level II, 28 at level V, 10 at level IV, 7 at level III, and 5 at Level I. CONCLUSION: This systematic review provides an overview of the most cited articles, published in general medical journals. The number of citations provides an indication of the quality of evidence. However, researchers and clinicians should use standardized assessment tools rather than solely rely on the number of citations in order to judge the quality of published articles.

Candy cane revision after Roux-en-Y gastric bypass.

BACKGROUND: An excessively long-blind end of the alimentary limb following a Roux-en-Y gastric bypass (RYGB), known as a 'candy cane' (CC), may cause symptoms including abdominal pain, regurgitation and vomiting. Very few studies have examined the efficacy of surgical resection of the CC. OBJECTIVES: The aim of this study was to assess sensitivity of preoperative diagnostic tools for CC, as well as perioperative outcomes and symptom resolution after CC revision surgery. SETTING: High volume bariatric centre of excellence, United Kingdom. METHODS: Observational study of CC revisions from 2010 to 2017. RESULTS: Twenty-eight CC revision cases were identified (mean age 45 ± 9 years, female preponderance 9:1). Presenting symptoms were abdominal pain (86%), regurgitation/vomiting (43%), suboptimal weight loss (36%) and acid reflux (21%). Preoperative tests provided correct diagnosis in 63% of barium contrast swallows, 50% of upper gastrointestinal endoscopies and 29% computed tomographies. Patients presenting with pain had significantly higher CC size as compared with pain-free group (4.2 vs. 2 cm, p = 0.001). Perioperative complications occurred in 25% of cases. Complete or partial symptom resolution was documented in 73% of patients undergoing CC revision. Highest success rates were recorded in the regurgitation/vomiting group (67%). CONCLUSION: Surgical revision of CC is associated with good symptom resolution in the majority of patients, especially those presenting with regurgitation/vomiting. However, it carries certain risk of complications. CC diagnosis may frequently be missed; hence more than one diagnostic tool should be considered when investigating symptomatic patients after RYGB.

Metabolic Changes and Diabetes Microvascular Complications 5 Years After Obesity Surgery.

BACKGROUND: Obesity surgery has pronounced effects on metabolic profile of patients with type 2 diabetes mellitus (T2DM); however, reports on long-term remission rates based on the standardised and holistic criteria by the International Diabetes Federation (IDF) and effects on T2DM microvascular complications are scarce in the literature. In this retrospective clinical trial, our objectives were to assess these variables 5 years after surgery. METHODS: Clinical data and direct measurements of renal and retinal damage were collected prospectively and analysed retrospectively for 82 patients with T2DM who underwent obesity surgery and were followed up for 5 years. RESULTS: The cohort of 82 patients with T2DM that were followed up 5 years after obesity surgery was predominantly female (71%) with a median age of 51 years, weight of 133.5 kg, BMI of 46.8 kg/m2 and pre-operative duration of T2DM of 8 years; 6% of patients had diet-controlled T2DM, 57% were on non-insulin treatment and 37% were on insulin treatment pre-operatively. Of the total 82 patients, 59 patients underwent Roux-en-Y gastric bypass, 15 sleeve gastrectomy and 8 patients underwent gastric band operations. At 5 years, 5% and 15% patients achieved optimisation and improvement of the metabolic state based on the IDF criteria respectively. Surgery was associated with almost halving of the albumin-creatinine ratio in 22 patients with pre-existing albuminuria (follow-up data available for 64 patients) and an overall stabilisation of retinopathy in 24 patients with retinal images available at 5 years. CONCLUSION: Whilst the findings on microvascular complications are encouraging, the rates of metabolic remission were lower than expected and raise the need for validated protocols to assist clinicians in managing these patients more aggressively post-operatively to achieve optimum cardio-metabolic risk factor control and hopefully further reduction in microvascular and macrovascular complications.

Systematic review on citation classics in minimally invasive gastrointestinal surgery.

BACKGROUND: The impact an article has on a specific field is manifested by its number of citations. The aim of this systematic review was to perform a citation analysis and identify the 100 most-cited articles in the field of minimally invasive (MI) gastrointestinal (GI) surgery. METHODS: The Institute for Scientific Information Web of Knowledge (1945-2017) was utilised to identify the top 100 most-cited articles in the field of MI GI surgery, using 19 distinct keywords. The data extracted were number of citations, time of publication, research topic, level of evidence, authorship and country of origin. RESULTS: Of the 100 most-cited articles, the number of citations ranged from 3331 to 317 citations. Most publications reported on bariatric surgery (n = 36), followed by oncology (n = 26) and hepatobiliary surgery (n = 15). The studies were published in 26 different journals with the top three journals being Annals of Surgery (n = 30), New England Journal of Medicine (n = 10) and Obesity Surgery (n = 9). The studies were conducted in 17 different countries led by the USA (n = 51), the UK (n = 9) and France (n = 6). Articles were published on all levels of evidence: level I (n = 20), Level II (n = 29), Level III (n = 8), Level IV (n = 29) and Level V (n = 14). CONCLUSION: The study revealed citation classics in the field of MI surgery. Interestingly, a high level of evidence was not significantly associated with an increased citation number.

Gallbladder perforation into the greater omentum following sleeve gastrectomy: A case report study.

INTRODUCTION: Obesity is considered a major risk factor for gallstone formation and is important due to its increasing prevalence worldwide. Many studies have reported an increased incidence of gallstone formation following bariatric surgery. This report documents a rare case of a complicated cholecystitis following sleeve gastrectomy and describes our management of the case and the management options for gallbladder disease in bariatric patients. PRESENTATION OF CASE: A 60-year-old male was diagnosed with asymptomatic cholelithiasis at the time of sleeve gastrectomy for obesity treatment. Two months after the procedure, he presented to the emergency department with symptoms of acute cholecystitis, which were initially managed conservatively. Six weeks later, he underwent a laparoscopic cholecystectomy. Intra-operative findings revealed a rare case of a complicated cholecystitis where the gallstone was half-eroded into the greater omentum. DISCUSSION: A notable proportion of bariatric patients develop symptomatic complicated cholecystitis following laparoscopic sleeve gastrectomy, compared to the normal population. Furthermore, complications develop quickly and technical difficulties are associated with subsequent surgeries. Thus, early cholecystectomy is justified. CONCLUSION: Patients with asymptomatic cholelithiasis, undergoing sleeve gastrectomy, may benefit from concomitant cholecystectomy. The question is yet controversial. This highlights the need for more clinical research in the field.

An Endoscopic Strategy Combining Mega Stents and Over-The-Scope Clips for the Management of Post-Bariatric Surgery Leaks and Fistulas (with video).

BACKGROUND AND AIMS: Endoscopic stenting has proved effective in the management of post-surgical leaks but is strongly hampered by the high rate of stent migration. In this study, we evaluate our experience with a new approach involving the use of novel ultra-large expandable stents tailored for bariatric surgery leaks (Mega stents), combined with the use of the innovative over-the-scope clips (OTSC). METHODS: Retrospective analysis of patients with post-bariatric surgery leaks managed at our institution by an approach combining Mega stents and over-the-scope clips. RESULTS: Twenty-two patients were treated for post-bariatric surgery leaks; 13 (59%) had a sleeve gastrectomy while nine (41%) had a RYGB. A total of 30 stents were inserted. Successful endoscopic insertion and removal were achieved in all patients. OTSC clips were applied in 12 patients (55%); five simultaneously with stents and seven after stent removal. Primary closure (after one endoscopic procedure) was achieved in 13 patients (59%) and in a total of 18 patients after multiple endoscopic procedures (82%). An average of 1.4 stents and 2.8 endoscopic procedures were required per patient. Stent migration occurred in four patients (18%), and all were retrievable endoscopically. Other complications included retrosternal pain and vomiting in 20 patients (91%) including one necessitating early removal, bleeding in two patients (9%), and perforation and esophageal stricture in one patient each (5%). Two mortalities were encountered, and one of them was stent-related (bleeding). CONCLUSION: Mega stents are effective in the management of post-bariatric surgery leaks. The combined use of Mega stents and OTSC clips is associated with a low incidence of migration and a low number of stents and procedures required per patient.

The impact of obesity surgery on musculoskeletal disease.

Obesity is an important modifiable risk factor for musculoskeletal disease. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant systematic review of bariatric surgery on musculoskeletal disease symptoms was performed. One thousand nineteen papers were identified, of which 43 were eligible for data synthesis. There were 79 results across 24 studies pertaining to physical capacity, of which 53 (67 %) demonstrated statistically significant post-operative improvement. There were 75 results across 33 studies pertaining to musculoskeletal pain, of which 42 (56 %) demonstrated a statistically significant post-operative improvement. There were 13 results across 6 studies pertaining to arthritis, of which 5 (38 %) demonstrated a statistically significant post-operative improvement. Bariatric surgery significantly improved musculoskeletal disease symptoms in 39 of the 43 studies. These changes were evident in a follow-up of 1 month to 10 years.

Ventricular remodelling post-bariatric surgery: is the type of surgery relevant? A prospective study with 3D speckle tracking.

AIMS: The aim of the study was to examine ventricular remodelling in patients free of cardiac risk factors, before, and 6 months post-bariatric surgery with the new imaging modality of three-dimensional (3D) strain and the comparison of two surgical techniques: sleeve gastrectomy vs. gastric bypass. METHODS AND RESULTS: Fifty-two consecutive patients referred to the Bariatric Services of Imperial College NHS Trust were examined with conventional 2D and 3D strain echocardiography, prior to and 6 months after bariatric surgery. They were all free from cardiac disease. The study cohort's mean age was 44.2 ± 8.7 years and body mass index of 42.4 ± 4.6 g/m(2) prior to surgery. Eighteen patients (34.6%) underwent laparoscopic sleeve gastrectomy, and 34 laparoscopic gastric bypass. On 3D speckle tracking, there was significant reverse remodelling post-bariatric surgery [left ventricular (LV) ejection fraction (EF): pre-surgery: 59 ± 8% vs. post-surgery: 67 ± 7%, P < 0.001 and right ventricular (RV) EF: pre-surgery: 60 ± 9% vs. post-surgery: 68 ± 8.2%, P = 0.0001]. Furthermore, there was significant regression of mass (LV mass: pre-surgery: 111 ± 23.5 g vs. post-surgery: 92.8 ± 15.5 g and RV mass: pre-surgery: 95.2 ± 19.8 vs. post-surgery: 67.3 ± 16.3, P < 0.001). RV and LV global strain improved 6 months post-bariatric surgery: global RV strain: pre-surgery -11.7 ± 4 vs. post-surgery -17.52 ± 3.7, P < 0.001; global LV strain: pre-surgery: -20.2 ± 1.7 vs. post-surgery: -26.5 ± 1.86, P < 0.001. Sleeve gastrectomy and gastric bypass had comparable effects. CONCLUSION: Bariatric surgery has an important effect in reverse LV and RV remodelling and it substantially improves RV longitudinal strain.

Enhanced recovery after bariatric surgery (ERABS): clinical outcomes from a tertiary referral bariatric centre.

There is paucity of data on Enhanced Recovery After Bariatric Surgery (ERABS) protocols. This feasibility study reports outcomes of this protocol utilized within a tertiary-referral bariatric centre. Data on consecutive primary procedures (laparoscopic gastric bypasses, sleeve gastrectomies and gastric bands) performed over 9 months within an ERABS protocol were prospectively recorded. Interventions utilized included shortened preoperative fasts, intra-operative humidification, early mobilization and feeding, avoidance of fluid overload, incentive spirometry, use of prokinetics and laxatives. Data collected included demographics, co-morbidities, morbidity, mortality, length of stay (LOS) and re-admissions. A total of 226 procedures (age [mean ± SD], 45 ± 11 years, median [interquartile range] BMI 44.9 [41.0-49.0] kg/m2) were undertaken: 150 (66%) bypasses, 47 (21%) sleeves and 29 (13%) bands. Hypertension, diabetes mellitus, sleep apnea and limited mobility were present in 40%, 34%, 24% and 9% of patients, respectively. No anastomotic or staple line leaks/bleeds were encountered. Ten (4.4%) patients developed postoperative morbidity (mainly respiratory complications). One death occurred from massive pulmonary embolus in a high-risk patient (despite insertion of preoperative-IVC filter). Respective mean ± SD LOS for bypasses, sleeves and bands were 1.88 ± 1.12, 2.30 ± 1.69 and 0.69 ± 0.81 days. Successful discharge on the first postoperative day was achieved in 37% and 28% of bypasses and sleeves, respectively. Day-case gastric bands were performed in 48%. Thirty-day hospital re-admission occurred in six (2.7%) patients. Applying an ERABS protocol was feasible, safe, associated with low morbidity, acceptable LOS and low 30-day re-admission rates. The presence of multiple medical co-morbidities should not preclude use of an ERABS protocol within bariatric patients.

The effect of bariatric surgery on echocardiographic indices: a review of the literature.

Obesity is the new epidemic and is associated with an increased risk of diastolic and systolic heart failure. Effective treatment options with drastic results such as bariatric surgery have raised interest in the possible reversal of some of the cardiovascular sequelae. Many studies have assessed individually the effect of weight loss on specific echocardiographic indices, mostly employing nonhomogeneous groups. The purpose of this narrative review is to summarise the effect of bariatric surgery on echocardiographic indices of biventricular function and to help in the understanding of the expected echocardiographic changes in bariatric patients after weight-loss surgery.

The use of multimedia consent programs for surgical procedures: a systematic review.

OBJECTIVE: To compare multimedia and standard consent, in respect to patient comprehension, anxiety, and satisfaction, for various surgical/interventional procedures. DATA SOURCES: Electronic searches of PubMed, MEDLINE, Ovid, Embase, and Google Scholar were performed. Relevant articles were assessed by 2 independent reviewers. STUDY SELECTION: Comparative (randomized and nonrandomized control trials) studies of multimedia and standard consent for a variety of surgical/interventional procedures were included. Studies had to report on at least one of the outcome measures. DATA EXTRACTION: Studies were reviewed by 2 independent investigators. The first investigator extracted all relevant data, and consensus of each extraction was performed by a second investigator to verify the data. CONCLUSION: Overall, this review suggests that the use of multimedia as an adjunct to conventional consent appears to improve patient comprehension. Multimedia leads to high patient satisfaction in terms of feasibility, ease of use, and availability of information. There is no conclusive evidence demonstrating a significant reduction in preoperative anxiety.