Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI≥45
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Randomizing for EPGB procedure, Randomizing for OAGB procedure.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher: a Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Randomizing for EPGB procedure
Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires. - Procedure Randomizing for OAGB procedure
Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires.
Primary outcome measures
- Weightloss short term [Time frame: 1, 3 and 5 years postoperatively]
Secondary outcome measures (12)
- Weightloss long term [Time frame: 5-10 years postoperatively]
- Complications short term [Time frame: up to 30 days postoperatively]
- Complications long term [Time frame: from 30 days until 10 years postoperatively]
- Revision of the bypass [Time frame: until 10 years postoperatively]
- Comorbidities [Time frame: until 10 years postoperatively]
- Deficiencies in blood - red blood count [Time frame: until 10 years postoperatively]
- Deficiencies in blood - vitamins [Time frame: until 10 years postoperatively]
- Deficiencies in blood - electrolytes [Time frame: until 10 years postoperatively]
- Reflux/dumping questionnaire [Time frame: until 10 years postoperatively]
- Health related quality of life questionnaire [Time frame: until 10 years postoperatively]
- Peroperative complications [Time frame: until 10 years postoperatively]
- Number of patients with peroperative conversion to sleeve [Time frame: until 10 years postoperatively]
Eligibility criteria
Inclusion criteria
- BMI≥45
- Bariatric guidelines Fried
- Age 18-65
- Dedication to guided preoperative program
- Intention to follow full postoperative program
Exclusion criteria
- Secondary bariatric procedure
- Medical(-related) cause for morbid obesity or fast weight gain (e.g. Cushing or medication related)
- Inflammatory Bowel Disease (M. Crohn or Colitis Ulcerosa)
- Renal function disorder (MDRD <30) or liver disease
- Anticipated absence of yearly medical follow up
- Does not speak Dutch language
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06204939 · 1