Extending and Banding the Roux-en-Y Gastric Bypass (UPGRADE)

Rijnstate Hospital

Status: Active, not recruiting

Conditions: Morbid Obesity

Treatments: Procedure: Extended Pouch RYGB; Procedure: Banded extended pouch RYGB; Procedure: Standard RYGB

Study type: Interventional

Funder types: Other

Identifiers

NCT05357807

NL62168.091.17

Details and patient eligibility

About

The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.

Full description

The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.

A prospective randomize controlled trial.

Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI > 40 kg/m2 without any comorbidities.

Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.

Enrollment: 375 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who are eligible for a primary RYGB

Exclusion criteria

• Bariatric surgery in medical history
• Patients with a language barrier which may affect the compliance with medical advice
• Patients with a disease not related to morbid obesity, such as Cushing or drug related.
• Chronic bowel disease for example Crohn's disease or colitis Colitis.
• Renal impairment (MDRD <30)
• Hepatic dysfunction (liver function twice the normal values)
• Pregnancy during follow-up
• Patients with treatment-resistant reflux symptoms.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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375 participants in 3 patient groups

Standard RYGB

Active Comparator group

Description:

127 patients undergo a standard Roux-en-Y gastric bypass

Treatment:

Procedure: Standard RYGB

Extended Pouch RYGB

Experimental group

Description:

127 patients undergo a Roux-en-Y gastric bypass with an extended pouch.

Treatment:

Procedure: Extended Pouch RYGB

Banded Extended RYGB

Experimental group

Description:

127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch.

Treatment:

Procedure: Banded extended pouch RYGB