Open label, prospective, randomized controlled trial of an endoscopic duodenal-jejunal bypass sleeve versus low calorie diet for pre-operative weight loss in bariatric surgery

Abstract Background Previous studies have investigated weight loss caused by exercise following bariatric surgery. However, in most cases, the training program is poorly reported; the exercise type, volume, and intensity are briefly mentioned; and the sample size, selection criteria, and follow-up time vary greatly across studies. Purpose The EFIBAR study aims to investigate over 1 year the effects of a 16-week supervised exercise program, initiated immediately after bariatric surgery, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, and quality of life in patients with severe/extreme obesity. Material and Methods The EFIBAR study is a parallel-group, superiority, randomized controlled trial (RCT), comprising 80 surgery patients. Half of the participants, randomly selected, perform a 16-week supervised exercise program, including both strength and aerobic training, starting immediately after the surgery (7–14 days). For each participant, all primary and secondary outcomes are measured at three different time points: (i) before the surgery, (ii) after the intervention (≈4 months), and (iii) 1 year after the surgery. Conclusion The EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery. Trial Registration EFIBAR randomized controlled trial was prospectively registered at Clinicaltrials.gov (NCT03497546) on April 13, 2018. Graphical abstract

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An Open-Label Prospective Randomized Controlled Trial of Mechanical Bowel Preparation vs Nonmechanical Bowel Preparation in Elective Colorectal Surgery: Personal Experience

Indian Journal of Surgery ◽

10.1007/s12262-015-1262-3 ◽

2015 ◽

Vol 77 (S3) ◽

pp. 1233-1236 ◽

Cited By ~ 5

Author(s):

Prosanta Kumar Bhattacharjee ◽

Saibal Chakraborty

Keyword(s):

Randomized Controlled Trial ◽

Colorectal Surgery ◽

Bowel Preparation ◽

Personal Experience ◽

Controlled Trial ◽

Mechanical Bowel Preparation ◽

Open Label ◽

Elective Colorectal Surgery ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial

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Different Limb Lengths in Gastric Bypass Surgery: Study Protocol for A Swiss Multicenter Randomized Controlled Trial (SLIM)

10.21203/rs.3.rs-31539/v1 ◽

2020 ◽

Author(s):

Marko Kraljević ◽

Romano Schneider ◽

Bettina Wölnerhanssen ◽

Marco Bueter ◽

Tarik Delko ◽

...

Keyword(s):

Bariatric Surgery ◽

Body Mass Index ◽

Weight Loss ◽

Randomized Controlled Trial ◽

Gastric Bypass ◽

Body Mass ◽

Controlled Trial ◽

Morbidly Obese ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

Abstract Background Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions. In morbidly obese patients, bariatric operations lead to sustained weight loss and relief of comorbidities in the majority of patients. Laparoscopic Roux-Y-gastric bypass (RYGB) is one of the most frequently performed operations, but it is still unknown why some patients respond better than others. Therefore, a number of variations of this operation have been introduced. Recent evidence suggests that a longer bypassed biliopancreatic limb (BPL) has the potential to be more effective compared to the standard RYGB with a shorter BPL length. This article describes the design and protocol of a randomized controlled trial comparing the outcome of a RYGB operation with a long versus short BPL.Methods/Design The trial is designed as a multicenter, randomized, patient and observer blinded trial. The relevant ethics committee has approved the trial protocol. To demonstrate that long BPL RYGB is superior compared to short BPL RYGB in terms of weight loss and resolution of T2DM the study is conducted as a superiority trial. Postoperative percent excess body mass index loss (%EBMIL) is the primary endpoint, whereas morbidity, mortality, remission of obesity related comorbidities and quality of life are secondary endpoints. Eight hundred patients, between 18 and 65 years and with a body mass index (BMI) from 35 to 60 kg/m2 who meet the regulatory rules for bariatric surgery in Switzerland will be randomized. The endpoints and baseline measurements will be assessed pre-, intra- and postoperatively.Discussion With its high number of patients and a 5-year follow-up this study will answer questions about effectiveness and safety of long BPL RYGB and provide level I evidence for improvement of the standard RYGB. These findings might therefore potentially influence global bariatric surgery guidelines.Trial registration This trial was registered on ClinicalTrials.gov under the identifier NCT04219787, on January 7th, 2020.

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