Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI≥45
- Conditions
- Bariatric Surgery Candidate
- Interventions
- Procedure: Randomizing for EPGB procedureProcedure: Randomizing for OAGB procedure
- Registration Number
- NCT06204939
- Lead Sponsor
- L. van Hogezand
- Brief Summary
The classic RYGB is in most patients with a BMI ≥45 technically not feasible. Two alternatives are the Extended Pouch Gastric Bypass and the One Anastomosis gastric bypass. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
- Detailed Description
Obesity is of increasing incidence worldwide. With it come major social-economical, medical and psychological problems which lead to high healthcare costs. Bariatric surgery is the most efficient treatment for morbid obesity, with the Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (GS) being the most performed.
The RYGB is preferable since this technique seems to lead to more reduction of obesity related comorbidities (DM2) and more weightloss in the long term. However, the RYGB is technically less feasible in patients with a BMI ≥45, due to less intra-abdominal space (excess fat in mesenterium) to connect the anastomosis tension-free.
An alternative for the RYGB are the Extended Pouch gastric bypass (EPGB) and the One-Anastomosis gastric bypass (OAGB). These techniques both involve an extended pouch which makes it easier to connect the anastomosis tension-free.
Furthermore, the extended pouch in the EPGB and OAGB could provide slower passage of food and stretches less on the longer term than the 'normal size'pouch in the RYGB, possibly leading to more weightloss (1,2).
Previous studies comparing the EPGB and RYGB showed more weightloss in patient undergoing EPGB and less weight gain in the long term (3). Other studies comparing the OAGB, RYGB and GS showed non-inferiority or even superiority of the OAGB for weightloss and remission of obesity related comorbidities as diabetes mellitus type 2 (DM2) and obstructive sleep apnea syndrome (OSAS) (4,5,6,7).
Theoretically the OAGB is a simpler procedure which reduces the risk of internal herniation and anastomotic leakage, since only one anastomosis is made (6,8) Only performing one anastomosis leads to less operating time, shorter time of anesthesia, and less usage of staple material. Which possibly makes this a safer and cheaper procedure.
Both techniques, EPGB and OAGB, seem to be adequate alternatives for the RYGB in patients with a BMI of 45 or higher. As of yet, the two techniques haven't been compared one to one. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended Pouch gastric bypass (EPGB) Randomizing for EPGB procedure Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. One Anastomosis gastric bypass (OAGB) Randomizing for OAGB procedure Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm.
- Primary Outcome Measures
Name Time Method Weightloss short term 1, 3 and 5 years postoperatively percentage excess weight loss
- Secondary Outcome Measures
Name Time Method Weightloss long term 5-10 years postoperatively percentage excess weight loss
Health related quality of life questionnaire until 10 years postoperatively Questionnaires on HrQoL and patient satisfaction of procedure, scales 0-5 and 0-10, higher is worse outcome
Deficiencies in blood - red blood count until 10 years postoperatively Blood samples: red blood count
Deficiencies in blood - electrolytes until 10 years postoperatively Blood samples: electrolytes
Number of patients with peroperative conversion to sleeve until 10 years postoperatively Conversion to sleeve when bypass not feasible
Complications short term up to 30 days postoperatively bleeding, leakage, infections, intra-abdominal abcess, readmission, mortality
Complications long term from 30 days until 10 years postoperatively vitamin/electrolyte deficiencies, internal herniation, marginal ulceration
Revision of the bypass until 10 years postoperatively Surgical revision of bypass
Comorbidities until 10 years postoperatively Reduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome
Deficiencies in blood - vitamins until 10 years postoperatively Blood samples vitamins
Reflux/dumping questionnaire until 10 years postoperatively Questionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome
Peroperative complications until 10 years postoperatively Peroperative complications: bleeding, iatrogenic complications