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

Bariatric Surgery Candidate Clinical Trial

— EXPANT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06204939
• Other study ID #: 1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 1, 2029

Study information

• Verified date: January 2024
• Source: St. Antonius Hospital
• Contact: Lilian van Hogezand, MD
• Phone: +31883206151
• Email: l.van.hogezand[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
L. van Hogezand	Rijnstate Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weightloss short term	percentage excess weight loss	1, 3 and 5 years postoperatively
Secondary	Weightloss long term	percentage excess weight loss	5-10 years postoperatively
Secondary	Complications short term	bleeding, leakage, infections, intra-abdominal abcess, readmission, mortality	up to 30 days postoperatively
Secondary	Complications long term	vitamin/electrolyte deficiencies, internal herniation, marginal ulceration	from 30 days until 10 years postoperatively
Secondary	Revision of the bypass	Surgical revision of bypass	until 10 years postoperatively
Secondary	Comorbidities	Reduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome	until 10 years postoperatively
Secondary	Deficiencies in blood - red blood count	Blood samples: red blood count	until 10 years postoperatively
Secondary	Deficiencies in blood - vitamins	Blood samples vitamins	until 10 years postoperatively
Secondary	Deficiencies in blood - electrolytes	Blood samples: electrolytes	until 10 years postoperatively
Secondary	Reflux/dumping questionnaire	Questionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome	until 10 years postoperatively
Secondary	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
Secondary	Peroperative complications	Peroperative complications: bleeding, iatrogenic complications	until 10 years postoperatively
Secondary	Number of patients with peroperative conversion to sleeve	Conversion to sleeve when bypass not feasible	until 10 years postoperatively