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Which revision surgery works best for weight regain after gastric bypass?

NCT ID NCT04894838

Disease control Sponsor: St. Antonius Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two types of distal gastric bypass surgery for people who regained weight or didn't lose enough after an initial Roux-en-Y gastric bypass. About 150 participants will be randomly assigned to one of the two procedures and followed for three years. The main goals are weight loss and checking for malnutrition or diarrhea.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Distal gastric bypass (revision surgery)
What this could lead to
If successful, this could identify the better surgical technique for helping people lose weight again after a failed gastric bypass.
What could go wrong
This is a surgical trial with risks like malnutrition and diarrhea. It is not a cure for obesity, and results may vary by patient.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-65 years; * BMI ≥40 kg/m2 or BMI ≥35 kg/m2 with obesity related comorbidity; * Weight regain or insufficient weight loss (EWL\<50% or TWL\<20%)15,16 following RYGB; * Multidisciplinary team screening at one of the bariatric centres; * Informed consent and willing to enter the follow-up program. Exclusion Criteria: * Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric pouch dilatation \>50 mL, gastro-gastric fistula, gastro-jejunostomy); * Distalisation of RYGB is technical infeasible (judgment by surgeon); * Inflammatory bowel disease, celiac disease, irritable bowel syndrome and other causes of chronic diarrhea; * Severe concomitant disease (such as carcinomas and neurodegenerative disorders); * Pregnant women; * Noncompliance in follow-up or unwilling to undergo surgery; * Inability of reading/understanding and filling out questionnaires.

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Conditions

The condition(s) this trial relates to.

morbid obesity Obesity Weight Gain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity, morbid Weight gain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bravis Hospital

    RECRUITING

    Roosendaal, North Brabant, 4708 AE, Netherlands

    Contact Email: •••••@•••••

  • Catharina Ziekenhuis

    NOT_YET_RECRUITING

    Eindhoven, North Brabant, 5623 EJ, Netherlands

  • Elisabeth-Tweesteden Hospital

    RECRUITING

    Tilburg, North Brabant, 5022 GC, Netherlands

  • Groene Hart Hospital

    NOT_YET_RECRUITING

    Gouda, South Holland, 2803 HH, Netherlands

  • Medisch Centrum Leeuwarden

    RECRUITING

    Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

  • OLVG

    RECRUITING

    Amsterdam, North Holland, 1061 AE, Netherlands

  • Rijnstate Hospital

    RECRUITING

    Arnhem, Gelderland, 6815 AD, Netherlands

  • St. Antonius hospital

    RECRUITING

    Nieuwegein, Utrecht, 3435 CM, Netherlands

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