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

Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Randomizing for EPGB procedure; Procedure: Randomizing for OAGB procedure

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lilian van Hogezand, MD; Phone Number: +31883206151; Email: l.van.hogezand@antoniusziekenhuis.nl
• Study Contact Backup: Name: Wetenschapsloket St. Antonius Ziekenhuis; Phone Number: +31883208761; Email: wetenschapsloket@antoniusziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Other: One Anastomosis gastric bypass (OAGB); Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weightloss short term	percentage excess weight loss	1, 3 and 5 years postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weightloss long term	percentage excess weight loss	5-10 years postoperatively
Complications short term	bleeding, leakage, infections, intra-abdominal abcess, readmission, mortality	up to 30 days postoperatively
Complications long term	vitamin/electrolyte deficiencies, internal herniation, marginal ulceration	from 30 days until 10 years postoperatively
Revision of the bypass	Surgical revision of bypass	until 10 years postoperatively
Comorbidities	Reduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome	until 10 years postoperatively
Deficiencies in blood - red blood count	Blood samples: red blood count	until 10 years postoperatively
Deficiencies in blood - vitamins	Blood samples vitamins	until 10 years postoperatively
Deficiencies in blood - electrolytes	Blood samples: electrolytes	until 10 years postoperatively
Reflux/dumping questionnaire	Questionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome	until 10 years postoperatively
Health related quality of life questionnaire	Questionnaires on HrQoL and patient satisfaction of procedure, scales 0-5 and 0-10, higher is worse outcome	until 10 years postoperatively
Peroperative complications	Peroperative complications: bleeding, iatrogenic complications	until 10 years postoperatively
Number of patients with peroperative conversion to sleeve	Conversion to sleeve when bypass not feasible	until 10 years postoperatively

Collaborators and Investigators

• Sponsor: L. van Hogezand
• Collaborators: Rijnstate Hospital
• Investigators: Principal Investigator: Wouter Derksen, MD PhD, St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: gastric bypass; bariatric; extended pouch; one anastomosis
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No