Bariatric Surgery CandidateEXPANTNCT06204939
Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI≥45
A study testing Randomizing for EPGB procedure and Randomizing for OAGB procedure in people with Bariatric Surgery Candidate, run by L. van Hogezand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Randomizing for EPGB procedure and Randomizing for OAGB procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI≥45
- Bariatric guidelines Fried
- Age 18-65
- Dedication to guided preoperative program
- Intention to follow full postoperative program
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Randomizing for EPGB procedure, Randomizing for OAGB procedure
- Keywords
- bariatric, gastric bypass, extended pouch, one anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomizing for EPGB procedureProcedure or surgery
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.
Randomizing for OAGB procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Extended Pouch gastric bypass (EPGB) | Other | Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. Receives: Procedure: Randomizing for EPGB procedure |
| One Anastomosis gastric bypass (OAGB) | Other | Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm. Receives: Procedure: Randomizing for OAGB procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weightloss short term
percentage excess weight loss
Measured: 1, 3 and 5 years postoperatively
Secondary outcomes (12)
Weightloss long term
percentage excess weight loss
Measured: 5-10 years postoperatively
Complications short term
bleeding, leakage, infections, intra-abdominal abcess, readmission, mortality
Measured: up to 30 days postoperatively
Complications long term
vitamin/electrolyte deficiencies, internal herniation, marginal ulceration
Measured: from 30 days until 10 years postoperatively
Revision of the bypass
Surgical revision of bypass
Measured: until 10 years postoperatively
Comorbidities
Reduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome
Measured: until 10 years postoperatively
Deficiencies in blood - red blood count
Blood samples: red blood count
Measured: until 10 years postoperatively
Deficiencies in blood - vitamins
Blood samples vitamins
Measured: until 10 years postoperatively
Deficiencies in blood - electrolytes
Blood samples: electrolytes
Measured: until 10 years postoperatively
Reflux/dumping questionnaire
Questionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome
Measured: until 10 years postoperatively
Health related quality of life questionnaire
Questionnaires on HrQoL and patient satisfaction of procedure, scales 0-5 and 0-10, higher is worse outcome
Measured: until 10 years postoperatively
Peroperative complications
Peroperative complications: bleeding, iatrogenic complications
Measured: until 10 years postoperatively
Number of patients with peroperative conversion to sleeve
Conversion to sleeve when bypass not feasible
Measured: until 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Single blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L. van Hogezand
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Sponsor-investigator, L. van Hogezand, St. Antonius Hospital
- Investigators
- Wouter Derksen, MD PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204939
- Sponsor's protocol ID
- 1
- Acronym
- EXPANT
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06204939
- Acronym / sponsor ID
- EXPANT / 1
- Conditions
- Bariatric Surgery Candidate
- Keywords
- bariatric, gastric bypass, extended pouch, one anastomosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- L. van HogezandUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 12 Jan 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Extended Pouch gastric bypass (EPGB) | Other | Procedure: Randomizing for EPGB procedureClassic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. |
| One Anastomosis gastric bypass (OAGB) | Other | Procedure: Randomizing for OAGB procedureGastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI≥45
- Bariatric guidelines Fried
- Age 18-65
- Dedication to guided preoperative program
- Intention to follow full postoperative program
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Randomizing for EPGB procedureClassic 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. | Procedure or surgery | Extended Pouch gastric bypass (EPGB) |
| Randomizing for OAGB procedureGastric 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. | Procedure or surgery | One Anastomosis gastric bypass (OAGB) |
Primary outcome
Weightloss short term
Time frame: 1, 3 and 5 years postoperatively
percentage excess weight loss
12 secondary outcomes
Weightloss long term
Time frame: 5-10 years postoperatively
Complications short term
Time frame: up to 30 days postoperatively
Complications long term
Time frame: from 30 days until 10 years postoperatively
Revision of the bypass
Time frame: until 10 years postoperatively
Comorbidities
Time frame: until 10 years postoperatively
Deficiencies in blood - red blood count
Time frame: until 10 years postoperatively
Deficiencies in blood - vitamins
Time frame: until 10 years postoperatively
Deficiencies in blood - electrolytes
Time frame: until 10 years postoperatively
Reflux/dumping questionnaire
Time frame: until 10 years postoperatively
Health related quality of life questionnaire
Time frame: until 10 years postoperatively
Peroperative complications
Time frame: until 10 years postoperatively
Number of patients with peroperative conversion to sleeve
Time frame: until 10 years postoperatively
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 12 Jan 2024.
- Individual participant dataSharing planned: No. No sharing.
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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.
Wouter Derksen, MD PhD principal investigator
St. Antonius Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Randomizing for EPGB procedure and Randomizing for OAGB procedure in people with Bariatric Surgery Candidate, run by L. van Hogezand.
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: opening soon, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Lilian van Hogezand, MD (+31883206151, l.van.hogezand@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weightloss short term (time frame: 1, 3 and 5 years postoperatively). 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 12 Jan 2024.