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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06204939
Acronym
EXPANT
Enrollment
250
Registered
2024-01-12
Start date
2024-06-01
Completion date
2029-12-01
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

Keywords

bariatric, gastric bypass, extended pouch, one anastomosis

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.

Interventions

PROCEDURERandomizing 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.

PROCEDURERandomizing 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.

Sponsors

Rijnstate Hospital
CollaboratorOTHER
L. van Hogezand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patients will be randomized single blinded for one of two study arms/procedures. 3 years post-operative unblinding will be done for participants wishing this.

Intervention model description

Single blinded randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Weightloss short term1, 3 and 5 years postoperativelypercentage excess weight loss

Secondary

MeasureTime frameDescription
Complications short termup to 30 days postoperativelybleeding, leakage, infections, intra-abdominal abcess, readmission, mortality
Complications long termfrom 30 days until 10 years postoperativelyvitamin/electrolyte deficiencies, internal herniation, marginal ulceration
Revision of the bypassuntil 10 years postoperativelySurgical revision of bypass
Comorbiditiesuntil 10 years postoperativelyReduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome
Deficiencies in blood - red blood countuntil 10 years postoperativelyBlood samples: red blood count
Weightloss long term5-10 years postoperativelypercentage excess weight loss
Deficiencies in blood - electrolytesuntil 10 years postoperativelyBlood samples: electrolytes
Reflux/dumping questionnaireuntil 10 years postoperativelyQuestionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome
Health related quality of life questionnaireuntil 10 years postoperativelyQuestionnaires on HrQoL and patient satisfaction of procedure, scales 0-5 and 0-10, higher is worse outcome
Peroperative complicationsuntil 10 years postoperativelyPeroperative complications: bleeding, iatrogenic complications
Number of patients with peroperative conversion to sleeveuntil 10 years postoperativelyConversion to sleeve when bypass not feasible
Deficiencies in blood - vitaminsuntil 10 years postoperativelyBlood samples vitamins

Contacts

Primary ContactLilian van Hogezand, MD
l.van.hogezand@antoniusziekenhuis.nl+31883206151
Backup ContactWetenschapsloket St. Antonius Ziekenhuis
wetenschapsloket@antoniusziekenhuis.nl+31883208761

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026