Obesity, MorbidDISCOURSENCT04894838
DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
A study testing Distal gastric bypass in people with Obesity, Morbid and Weight Gain, run by St. Antonius Hospital at 8 sites in Netherlands.
Trial summary
This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Weight Gain
- What is being tested?
- Distal gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesNetherlands
- Study dates
- 1 May 2021to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Recruiting
OLVG
Amsterdam, North Holland, 1061 AE
R.N. Van Veen, PhD, MD, 0031 2051 08040, r.n.vanveen@olvg.nl
- Recruiting
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
E.J. Hazebroek, PhD, MD, 0031624242496, ehazebroek@rijnstate.nl
- Not yet recruiting
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Simon Nienhuijs, MD, PhD, 0031402399850, simon.nienhuijs@catharinaziekenhuis.nl
- Not yet recruiting
Groene Hart Hospital
Gouda, South Holland, 2803 HH
R.S.L. Liem, PhD, MD, 0031 7032 04703, ronald.liem@ghz.nl
- Recruiting
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
E.H. Jutte, PhD, MD, 0031 5828 66969, ewoud.jutte@mcl.nl
- Recruiting
St. Antonius hospital
Nieuwegein, Utrecht, 3435 CM
M.J. Wiezer, PhD, MD, 0031 6418 73500, r.wiezer@antoniusziekenhuis.nl
Lilian van Hogezand, MD, 0031648704498, l.van.hogezand@antoniusziekenhuis.nl
- Recruiting
Bravis Hospital
Roosendaal, North Brabant, 4708 AE
B. Torensma, PhD, MD, 0031 1642 78800, info@barttorensma.nl
- Recruiting
Elisabeth-Tweesteden Hospital
Tilburg, North Brabant, 5022 GC
B. Langenhoff, PhD, MD, 0031 1322 10310, b.langenhoff@etz.nl
About this study
This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.
Read the detailed description
Rationale: Up to 35% of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) fail to lose sufficient weight or regain excessive weight after initial weight loss. Currently, there is no standardized approach to revisional surgery after failed RYGB. Distalisation of the RYGB limbs (DGB), with shortening of the common channel and extending either the alimentary limb (AL) or biliopancreatic limb (BPL), can be performed as revisional surgery to induce additional weight loss. To date, there is no general consensus as to optimal surgical technique or limb lengths to be used in distalisation of RYGB in both literature as well as clinical practice.
Objective: The aim of this study is to investigate the effect of two distalisation techniques of a gastric bypass in revisional surgery with standardised limb lengths in total weight loss (TWL) and the need for treatment for protein calorie malnutrition (PCM). In this randomised controlled trial DGB with lengthening of the BPL (DGB type I) will be compared to DGB with extended AL (DGB type II) in order to conclude which surgical technique is the optimal therapeutic strategy as revision surgery following Roux-en-Y gastric bypass.
Study design: A multicentre randomised controlled trial.
Study population: Morbidly obese patients with insufficient weight loss or weight regain following primary RYGB, who are eligible for distalisation surgery.
Intervention: A total of 150 participants will be randomised over two treatment groups: group A will undergo DGB type I and group B will undergo DGB type II.
Main study endpoints: Primary endpoints: %TWL 1 year after treatment and need for treatment of PCM. Secondary endpoints: weight loss, co-morbidity remission, PCM grading (debilitating defecation patterns, temporary total parenteral nutrition treatment, revision, mortality), morbidity, nutritional deficiencies, quality of life and patient satisfaction.
- Conditions
- Obesity, Morbid, Weight Gain
- Being tested
- Distal gastric bypass
- Keywords
- Obesity, Weight regain, Failed RYGB, Distal gastric bypass
- Medical subject headings
- Obesity, Morbid, Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal gastric bypassProcedure or surgery
Distal gastric bypass, revisonal surgery after failed RYGB
| Study group | Role | What they receive |
|---|---|---|
| Distal gastric bypass type I | Experimental | Laparoscopic distalisation of RYGB type I. The RYGB is modified by dividing the Roux limb (AL) at the jejuno-jejunal anastomosis and re-anastomosed distally to 200 cm from the ileocecal valve using linear staplers, creating a long biliopancreatic limb (BPL). In cases of initial AL lengths shorter than 100 cm, the CC lengths should be adjusted to create a TALL of at least 300 cm. Receives: Procedure: Distal gastric bypass |
| Distal gastric bypass type II | Experimental | Laparoscopic distalisation of RYGB type II. The RYGB is modified by dividing the BPL at the jejuno-jejunal anastomosis and re-anastomosed distally to 200 cm from the ileocecal valve using linear staplers, creating a long AL. Receives: Procedure: Distal gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Percentage total weight loss (%TWL) 1 year after treatment
Measured: 1 year post-operative
Number of Participants with development of protein calorie malnutrition (PCM)
>6 times/day defecation patterns with diarrhea, assessed by fecal score questionnaire
Measured: 1 year postoperative
Secondary outcomes (9)
Weight loss
Patient weight in kilograms is collected preoperative up to 3 years follow-up to determine weight loss.
Measured: Up to 3 year follow up
TWL
Weight loss in kilograms at a follow-up time point divided by weight in kilograms measured at DGB
Measured: 3, 6, 12, 18, 24, 36 month follow up
Defecation pattern
Faecal score questionnaire to measure defecation frequencey and consistency
Measured: 3, 12 and 36 months postoperative
PCM grading
Information is collected about each patient who has undergone DGB to ascertain debilitating defecation patterns (grade I), requirement of f participants requiring temporary total parenteral nutrition (grade II, revision surgery (grade III), and mortality (grade IV) after DGB.
Measured: up to 3 year follow up
Complications
Information is collecting regarding the occurrence of one or more defined adverse events following DGB. Defined adverse events collected are: unplanned readmission to hospital, unplanned admission to the intensive care unit, unplanned return to the operating theatre, prolonged length of stay in hospital, and death. The reason for any of the events is also collected. If death occurs, the cause of death is collected to determine the likelihood of the death being caused by the DGB.
Measured: uo to 3 year follow up
Quality of life questionnaire
BODY-Q questionnaire
Measured: 3, 12 and 36 months postoperative
Impact defecation pattern questionnaire
Fecal incontinence quality of life scale FIQL questionnaires
Measured: 3, 12 and 36 months postoperative
Patient satisfaction questionnaire
Self-designed 5-point scale measuring instrument for patient satisfaction
Measured: 1 and 3 year postoperative
Eating behaviour questionnaire
Three factor earing questionnaire TFEQ R21
Measured: 3, 12 and 36 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 May 2021
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In total, 150 morbidly obese patients are eligible for distalisation surgery following RYGB. The participants will be randomised into DGB type I (group a) or DGB type II (group b). The study population consists of morbidly obese patients with insufficient weight loss or weight regain following primary Roux-en-Y gastric bypass, who are eligible for distalisation surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, M.J. Wiezer, St. Antonius Hospital
- Investigators
- M.J. Wiezer, PhD, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894838
- Sponsor's protocol ID
- NL75322.100.20/R20.093
- Acronym
- DISCOURSE
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
- ClinicalTrials.gov ID
- NCT04894838
- Acronym / sponsor ID
- DISCOURSE / NL75322.100.20/R20.093
- Conditions
- Obesity, Morbid, Weight Gain
- Keywords
- Obesity, Weight regain, Failed RYGB, Distal gastric bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 May 2021 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.
Detailed description
Rationale: Up to 35% of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) fail to lose sufficient weight or regain excessive weight after initial weight loss. Currently, there is no standardized approach to revisional surgery after failed RYGB. Distalisation of the RYGB limbs (DGB), with shortening of the common channel and extending either the alimentary limb (AL) or biliopancreatic limb (BPL), can be performed as revisional surgery to induce additional weight loss. To date, there is no general consensus as to optimal surgical technique or limb lengths to be used in distalisation of RYGB in both literature as well as clinical practice.
Objective: The aim of this study is to investigate the effect of two distalisation techniques of a gastric bypass in revisional surgery with standardised limb lengths in total weight loss (TWL) and the need for treatment for protein calorie malnutrition (PCM). In this randomised controlled trial DGB with lengthening of the BPL (DGB type I) will be compared to DGB with extended AL (DGB type II) in order to conclude which surgical technique is the optimal therapeutic strategy as revision surgery following Roux-en-Y gastric bypass.
Study design: A multicentre randomised controlled trial.
Study population: Morbidly obese patients with insufficient weight loss or weight regain following primary RYGB, who are eligible for distalisation surgery.
Intervention: A total of 150 participants will be randomised over two treatment groups: group A will undergo DGB type I and group B will undergo DGB type II.
Main study endpoints: Primary endpoints: %TWL 1 year after treatment and need for treatment of PCM. Secondary endpoints: weight loss, co-morbidity remission, PCM grading (debilitating defecation patterns, temporary total parenteral nutrition treatment, revision, mortality), morbidity, nutritional deficiencies, quality of life and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In total, 150 morbidly obese patients are eligible for distalisation surgery following RYGB. The participants will be randomised into DGB type I (group a) or DGB type II (group b). The study population consists of morbidly obese patients with insufficient weight loss or weight regain following primary Roux-en-Y gastric bypass, who are eligible for distalisation surgery.
| Arm | Type | Receives |
|---|---|---|
| Distal gastric bypass type I | Experimental | Procedure: Distal gastric bypassLaparoscopic distalisation of RYGB type I. The RYGB is modified by dividing the Roux limb (AL) at the jejuno-jejunal anastomosis and re-anastomosed distally to 200 cm from the ileocecal valve using linear staplers, creating a long biliopancreatic limb (BPL). In cases of initial AL lengths shorter than 100 cm, the CC lengths should be adjusted to create a TALL of at least 300 cm. |
| Distal gastric bypass type II | Experimental | Procedure: Distal gastric bypassLaparoscopic distalisation of RYGB type II. The RYGB is modified by dividing the BPL at the jejuno-jejunal anastomosis and re-anastomosed distally to 200 cm from the ileocecal valve using linear staplers, creating a long AL. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal gastric bypassDistal gastric bypass, revisonal surgery after failed RYGB | Procedure or surgery | Distal gastric bypass type I, Distal gastric bypass type II |
Primary outcome
Weight loss
Time frame: 1 year post-operative
Percentage total weight loss (%TWL) 1 year after treatment
Number of Participants with development of protein calorie malnutrition (PCM)
Time frame: 1 year postoperative
>6 times/day defecation patterns with diarrhea, assessed by fecal score questionnaire
9 secondary outcomes
Weight loss
Time frame: Up to 3 year follow up
TWL
Time frame: 3, 6, 12, 18, 24, 36 month follow up
Defecation pattern
Time frame: 3, 12 and 36 months postoperative
PCM grading
Time frame: up to 3 year follow up
Complications
Time frame: uo to 3 year follow up
Quality of life questionnaire
Time frame: 3, 12 and 36 months postoperative
Impact defecation pattern questionnaire
Time frame: 3, 12 and 36 months postoperative
Patient satisfaction questionnaire
Time frame: 1 and 3 year postoperative
Eating behaviour questionnaire
Time frame: 3, 12 and 36 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
M.J. Wiezer, PhD, MD principal investigator
St. Antonius Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal gastric bypass in people with Obesity, Morbid and Weight Gain, run by St. Antonius Hospital at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luna Tolenaars, MD (0031636434456, l.tolenaars@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 year post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.