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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2028
  • participants needed
    381
  • sponsor
    Rijnstate Hospital
Updated on 10 May 2022

Summary

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.

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.

Details
Condition Morbid Obesity
Treatment Standard RYGB, Extended Pouch RYGB, Banded extended pouch RYGB
Clinical Study IdentifierNCT05357807
SponsorRijnstate Hospital
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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