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1.
Trials ; 23(1): 900, 2022 Oct 22.
Article in English | MEDLINE | ID: mdl-36273149

ABSTRACT

BACKGROUND: Metabolic surgery induces rapid remission of type 2 diabetes mellitus (T2DM). There is a paucity of high level evidence comparing the efficacy of the laparoscopic Roux-en-Y gastric bypass (RYGB) and the laparoscopic one-anastomosis gastric bypass (OAGB) in glycemic control. Also, the mechanisms that drive the conversion of T2DM in severe obese subjects to euglycemia are poorly understood. METHODS: The DIABAR-trial is an open, multi-center, randomized controlled clinical trial with 10 years follow-up which will be performed in 220 severely obese patients, diagnosed with T2DM and treated with glucose-lowering agents. Patients will be randomized in a 1:1 ratio to undergo RYGB or OAGB. The primary outcome is glycemic control at 12 months follow-up. Secondary outcome measures are diverse and include weight loss, surgical complications, psychologic status and quality of life, dietary behavior, gastrointestinal symptoms, repetitive bloodwork to identify changes over time, glucose tolerance and insulin sensitivity as measured by mixed meal tests, remission of T2DM, presence of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis in liver biopsy, oral and fecal microbiome, cardiovascular performance, composition of bile acids, and the tendency to develop gallstones. DISCUSSION: The DIABAR-trial is one of the few randomized controlled trials primarily aimed to evaluate the glycemic response after the RYGB and OAGB in severe obese patients diagnosed with T2DM. Secondary aims of the trial are to contribute to a deeper understanding of the mechanisms that drive the remission of T2DM in severe obese patients by identification of microbial, immunological, and metabolic markers for metabolic response and to compare complications and side effects of RYGB and OAGB. TRIAL REGISTRATION: ClinicalTrials.gov NCT03330756 ; date first registered: October 13, 2017.


Subject(s)
Diabetes Mellitus, Type 2 , Gastric Bypass , Obesity, Morbid , Humans , Bile Acids and Salts , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/surgery , Gastric Bypass/adverse effects , Gastric Bypass/methods , Glycemic Control , Laparoscopy , Multicenter Studies as Topic , Obesity, Morbid/surgery , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome
2.
Obes Surg ; 31(6): 2380-2390, 2021 06.
Article in English | MEDLINE | ID: mdl-33813682

ABSTRACT

PURPOSE: There is considerable evidence on short-term outcomes after laparoscopic Roux-en-Y gastric bypass (LRYGB), but data on long-term outcome is scarce, especially on postoperative emergency department (ED) visits and readmissions. We aim to systematically review evidence on the incidence, indications, and risk factors of ED visits and readmissions beyond 30 days after LRYGB. MATERIALS AND METHODS: A systematic search in PubMed, Scopus, Embase.com , Cochrane Library, and PsycINFO was performed. All studies reporting ED visits and readmissions > 30 days after LRYGB, with ≥ 50 patients, were included. PRISMA statement was used and the Newcastle-Ottawa Scale for quality assessment. RESULTS: Twenty articles were included. Six studies reported on ED visits (n = 2818) and 19 on readmissions (n = 276,543). The rate of patients with an ED visit within 90 days after surgery ranged from 3.9 to 32.6%. ED visits at 1, 2, and 3 years occurred in 25.6%, 30.0%, and 31.1% of patients. Readmissions within 90 days and at 1-year follow-up ranged from 4.1 to 20.5% and 4.75 to 16.6%, respectively. Readmission was 29% at 2 years and 23.9% at 4.2 years of follow-up. The most common reason for ED visits and readmissions was abdominal pain. CONCLUSION: Emergency department visits and readmissions have been reported in up to almost one in three patients on the long-term after LRYGB. Both are mainly indicated for abdominal pain. The report on indications and risk factors is very concise. A better understanding of ED visits and readmissions after LRYGB is warranted to improve long-term care, in particular for patients with abdominal pains.


Subject(s)
Gastric Bypass , Laparoscopy , Obesity, Morbid , Emergency Service, Hospital , Gastric Bypass/adverse effects , Humans , Obesity, Morbid/surgery , Patient Readmission , Postoperative Complications/epidemiology , Retrospective Studies , Treatment Outcome
3.
J Intern Med ; 289(3): 340-354, 2021 03.
Article in English | MEDLINE | ID: mdl-32640105

ABSTRACT

INTRODUCTION: Prevalence of obesity and associated diseases, including type 2 diabetes mellitus, dyslipidaemia and non-alcoholic fatty liver disease (NAFLD), are increasing. Underlying mechanisms, especially in humans, are unclear. Bariatric surgery provides the unique opportunity to obtain biopsies and portal vein blood-samples. METHODS: The BARIA Study aims to assess how microbiota and their metabolites affect transcription in key tissues and clinical outcome in obese subjects and how baseline anthropometric and metabolic characteristics determine weight loss and glucose homeostasis after bariatric surgery. We phenotype patients undergoing bariatric surgery (predominantly laparoscopic Roux-en-Y gastric bypass), before weight loss, with biometrics, dietary and psychological questionnaires, mixed meal test (MMT) and collect fecal-samples and intra-operative biopsies from liver, adipose tissues and jejunum. We aim to include 1500 patients. A subset (approximately 25%) will undergo intra-operative portal vein blood-sampling. Fecal-samples are analyzed with shotgun metagenomics and targeted metabolomics, fasted and postprandial plasma-samples are subjected to metabolomics, and RNA is extracted from the tissues for RNAseq-analyses. Data will be integrated using state-of-the-art neuronal networks and metabolic modeling. Patient follow-up will be ten years. RESULTS: Preoperative MMT of 170 patients were analysed and clear differences were observed in glucose homeostasis between individuals. Repeated MMT in 10 patients showed satisfactory intra-individual reproducibility, with differences in plasma glucose, insulin and triglycerides within 20% of the mean difference. CONCLUSION: The BARIA study can add more understanding in how gut-microbiota affect metabolism, especially with regard to obesity, glucose metabolism and NAFLD. Identification of key factors may provide diagnostic and therapeutic leads to control the obesity-associated disease epidemic.


Subject(s)
Bariatric Surgery , Gastrointestinal Microbiome , Obesity, Morbid/metabolism , Obesity, Morbid/surgery , Research Design , Systems Biology , Adult , Biomarkers/metabolism , Fatty Liver/metabolism , Female , Glucose/metabolism , Humans , Insulin/metabolism , Longitudinal Studies , Male , Middle Aged , Netherlands , Phenotype , Triglycerides/metabolism
4.
BJS Open ; 3(3): 274-281, 2019 06.
Article in English | MEDLINE | ID: mdl-31183442

ABSTRACT

Background: Enhanced recovery after surgery (ERAS) programmes have led to a decreased duration of hospital stay in several surgical fields, but have not been fully tested in patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) for obesity. This study aimed to investigate an ERAS programme versus standard care in these patients. Methods: Between January 2013 and July 2014, patients undergoing LRYGB were randomized to ERAS or conventional care. The primary outcome was functional hospital stay, defined as the time between end of surgery and when predefined discharge criteria (pain adequately controlled, fever and postoperative nausea and vomiting (PONV) absent, full liquid diet tolerated, mobilized and feeling fit for discharge) were met. Secondary outcomes were total length of hospital stay, 30-day complication and mortality rates, duration of surgery, time spent on the recovery ward and health-related quality of life. Results: A total 220 patients were randomized to ERAS (110 patients) or conventional (110) care. Patients in the ERAS group had shorter functional hospital stay (17·4 versus 20·5 h; P < 0·001), quicker pain control, tolerated liquid diet earlier, had earlier control of PONV, mobilized sooner and were comfortable with discharge sooner than those receiving conventional care. Total length of hospital stay, duration of surgery, time spent on the recovery ward, health-related quality of life, complication and readmission rates did not differ between the study groups. There were no deaths. Conclusion: Patients under ERAS care recovered faster after LRYGB surgery than those receiving conventional care, with no increase in readmission and postoperative morbidity rates. Registration number: NTR3853 (http://www.trialregister.nl/).


Subject(s)
Enhanced Recovery After Surgery/standards , Gastric Bypass/statistics & numerical data , Laparoscopy/trends , Obesity, Morbid/surgery , Adult , Female , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Mortality/trends , Operative Time , Patient Discharge/statistics & numerical data , Patient Readmission/statistics & numerical data , Postoperative Complications/epidemiology , Postoperative Complications/mortality , Postoperative Nausea and Vomiting/epidemiology , Postoperative Period , Quality of Life/psychology
5.
Ned Tijdschr Geneeskd ; 161: D1249, 2017.
Article in Dutch | MEDLINE | ID: mdl-28745245

ABSTRACT

- Bariatric surgery is performed in patients with a body mass index (BMI) > 40kg/m2, or BMI > 35 kg/m2 with obesity-related comorbidities. The Roux-en-Y gastric bypass and sleeve gastrectomy are the most frequently used procedures.- On average, patients have lost 25-27% of their original weight 10 years after surgery.- Obesity-related comorbidities improve dramatically in many patients following surgery. The effect is most noticeable in patients with diabetes mellitus type 2 and obstructive sleep apnoea syndrome. - The prevalence of 30-day complications is < 5%. Mortality is < 0.2% in centres with a lot of experience. - Commonly occurring long-term complications of bariatric surgery include deficiencies, particularly of iron and vitamin B12, along with gallstone disease and sagging skin. - Specific complications can arise following Roux-en-Y gastric bypass, such as internal herniation and hypoglycaemia, and these are often not recognised.


Subject(s)
Bariatric Surgery/methods , Obesity, Morbid/surgery , Weight Loss , Gastric Bypass , Humans , Laparoscopy
6.
Eur J Surg Oncol ; 29(8): 682-8, 2003 Oct.
Article in English | MEDLINE | ID: mdl-14511618

ABSTRACT

AIM: Pseudomyxoma peritonei (PMP) is a rare disease characterized by the abundance of mucus in the abdomen without extra-peritoneal growth. METHODS: Our patients with PMP have been treated with cytoreduction and hyperthermic intraperitoneal chemotherapy since 1996. The clinical and histopathological features of PMP and the relation of these features with disease-free interval and survival were assessed. RESULTS: Sixty-two patients with PMP (24 M/38 F) were studied. Adenomatous mucosal changes were present in 31 patients. In females, the ovaries were normal in 5 patients and pseudomyxoma ovarii was present in 20 patients. Patients with minimal atypia and with 1% focal proliferation or less (n=38) had a better survival (p=0.0008) than those with more focal proliferation (n=14). CONCLUSION: In most patients with PMP the appendix is affected; in females the ovaries are usually also involved. Focal proliferation appears to be a prognostic factor.


Subject(s)
Peritoneal Neoplasms , Pseudomyxoma Peritonei , Adenocarcinoma, Mucinous/diagnosis , Adenocarcinoma, Mucinous/surgery , Adult , Aged , Disease-Free Survival , Female , Humans , Male , Medical Records , Middle Aged , Peritoneal Neoplasms/diagnosis , Peritoneal Neoplasms/pathology , Peritoneal Neoplasms/surgery , Pseudomyxoma Peritonei/diagnosis , Pseudomyxoma Peritonei/pathology , Pseudomyxoma Peritonei/surgery , Retrospective Studies , Survival Analysis
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