Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI≥45

NCT ID: NCT06204939

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2029-12-01

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.

Conditions

Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Extended Pouch gastric bypass (EPGB)

Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm.

Group Type: OTHER

Randomizing for EPGB procedure

Intervention Type: 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.

One Anastomosis gastric bypass (OAGB)

Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm.

Group Type: OTHER

Randomizing for OAGB procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

L. van Hogezand

OTHER

Sponsor Role: lead

Responsible Party

L. van Hogezand

Coordinating investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wouter Derksen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Central Contacts

Lilian van Hogezand, MD

Role: CONTACT

l.van.hogezand@antoniusziekenhuis.nl

+31883206151

Wetenschapsloket St. Antonius Ziekenhuis

Role: CONTACT

wetenschapsloket@antoniusziekenhuis.nl

+31883208761

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id