Morbid ObesityOAGB-vs-LRYGBNCT02779322
Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass
A study testing Minigastric bypass and Gastric bypass in people with Morbid Obesity and Postoperative Complications, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
This study try to identify differences in cost, length of operation and results between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the Single anastomosis laparoscopic gastric bypass. The study will be conducted in a Spanish public health system hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Postoperative Complications, Weight Loss
- What is being tested?
- Minigastric bypass and Gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
- age between 18-65 years-old.
- BMI between 40-50 kg/m2
- Obesity for more than 5 years of evolution
- Fail in medical supervised weight loss program
- patient knowing of the mechanism of weight loss after surgery and agreement to collaborate with medical recommendations, diet, medical treatment, as well as the visit established in the follow up program
Show all 9Show fewer
- patient accepting that surgery objective is not to achieve the ideal weight.
- signed specific informed consent
- women will agree in avoid gestation during one year after surgery
Who cannot join
- Patients unable to sign the informed consent form because of a mental disorder.
- endocrine diseases causing obesity
- unstable mental disorder, evaluated for a psychiatry MD.
- high anesthetic risk making surgery too risky.
- Malignant neoplasm
- Gastroesophageal reflux disease (GERD) with endoscopic esophagitis
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
About this study
Official title: Prospective Randomized Controlled Clinical Trial: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass
This study try to identify differences in cost, length of operation and results between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the Single anastomosis laparoscopic gastric bypass. The study will be conducted in a Spanish public health system hospital.
The patients of the trial will have the preoperative studies, hospital treatment during the admission, postoperative treatment and follow up as any other patient included in the hospital bariatric surgery program. No new methods are applied other than randomly choose the surgical technique.
Patients will be randomized in a 1:1 ratio to each group.
Read the detailed description
One group of patients of the study will have done the simplified laparoscopic gastric bypass, with a vertical gastric pouch of about 20 ml, a 150 cm Roux-en-Y limb constructed in an antegastric antecolic fashion, and a biliary limb of 100 cm. Anastomosis will be done with endoscopic surgical linear stapler, closing the apertures with continuous absorbable running sutures. The Petersen space and the mesenteric defect will be closed with non-absorbable sutures.
The other group of patients will have performed the single anastomosis gastric bypass, also known as the Minigastric bypass (MGB), which have a vertical gastric pouch about 100-150 ml, and an end to side gastro-jejunal anastomosis at 200 cm from Treitz angle. The anastomosis will be done with endoscopic surgical linear stapler, closing the aperture with continuous absorbable running sutures.The Petersen space will be also close with non-absorbable sutures.
The investigators randomly assigned 10 patients to each group, n=20. Considering that one of the methods is basically the same than the other, but for the Roux-en-Y construction, it is expected a clear difference in operating room (OR) time, between groups. Fisher Test, will be used for the statistical analysis, assuming a risk of 0.05 and a statistical power of 90%, and Mann-Whitney test for quantitative parameters.
Once patients were included in the study, they were randomized in a 1:1 ratio to the conventional laparoscopic gastric bypass group or the single-anastomosis laparoscopic gastric bypass (Mini gastric bypass) group and were also blinded to the surgeon until surgery. The method of randomization was concealed envelopes.
- Conditions
- Morbid Obesity, Postoperative Complications, Weight Loss
- Being tested
- Minigastric bypass, Gastric bypass
- Keywords
- gastric bypass, hospital charges, mini gastric bypass
- Medical subject headings
- Obesity, Morbid, Postoperative Complications, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minigastric bypassProcedure or surgery
Also called Single or One anastomosis gastric bypass
The patient will be submitted to a minigastric bypass at the time of the operation
Gastric bypassProcedure or surgery
Also called Laparoscopic gastric bypass
In this case a simplified conventional gastric bypass will be performed
| Study group | Role | What they receive |
|---|---|---|
| Minigastric bypass | Active comparator | Intervention(s): The patient will have done a Laparoscopic one anastomosis gastric bypass (minigastric bypass) at the time of the surgical procedure. Receives: Procedure: Minigastric bypass |
| Gastric bypass | Active comparator | The patient will have a Laparoscopic Roux-en-Y gastric bypass at the time of the surgical procedure Receives: Procedure: Gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Cost in euros
Total hospital expenses during admission for the surgery
Measured: up to 3 months
Length of operation in minutes
Duration of the surgical procedure
Measured: 1 day
Secondary outcomes (9)
weight loss in kilograms
weight of the patient at clinics, 3 months after surgery
Measured: 3 months
weight loss in kilograms
weight of the patient at clinics, 6 months after surgery
Measured: 6 months
weight loss in kilograms
weight of the patient at clinics, 9 months after surgery
Measured: 9 months
weight loss in kilograms
weight of the patient at clinics, 12 months after surgery
Measured: 12 months
weight loss in kilograms
weight of the patient at clinics, 18 months after surgery
Measured: 18 months
weight loss in kilograms
weight of the patient at clinics, 24 months after surgery
Measured: 24 months
weight loss in kilograms
weight of the patient at clinics, 3 years after surgery
Measured: 3 years
weight loss in kilograms
weight of the patient at clinics, 4 years after surgery
Measured: 4 years
weight loss in kilograms
weight of the patient at clinics, 5 years after surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2019
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel J. Garcia-Oria, Puerta de Hierro University Hospital
- Investigators
- Miguel J Garcia-Oria, MD PhD FACS, Study chair, Unidad Cirugia Obesidad y Metabolica Hospital Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779322
- Sponsor's protocol ID
- 06082015
- Acronym
- OAGB-vs-LRYGB
- Status last verified
- Apr 2020
- First submitted
- 16 May 2016
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The plan is to publish the results of our study in a scientific journal when it be completed, not to publish the individual patient data, just the global data comparing both groups of study.
Publications
Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
PubMed 23011462Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
PubMed 11433900Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.
PubMed 15973097Lee WJ, Lin YH. Single-anastomosis gastric bypass (SAGB): appraisal of clinical evidence. Obes Surg. 2014 Oct;24(10):1749-56. doi: 10.1007/s11695-014-1369-9.
PubMed 25056233Piche ME, Auclair A, Harvey J, Marceau S, Poirier P. How to choose and use bariatric surgery in 2015. Can J Cardiol. 2015 Feb;31(2):153-66. doi: 10.1016/j.cjca.2014.12.014. Epub 2014 Dec 15.
PubMed 25661550Ramos AC, Silva AC, Ramos MG, Canseco EG, Galvao-Neto Mdos P, Menezes Mde A, Galvao TD, Bastos EL. Simplified gastric bypass: 13 years of experience and 12,000 patients operated. Arq Bras Cir Dig. 2014;27 Suppl 1(Suppl 1):2-8. doi: 10.1590/s0102-6720201400s100002.
PubMed 25409956
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Clinical Trial: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass
- ClinicalTrials.gov ID
- NCT02779322
- Acronym / sponsor ID
- OAGB-vs-LRYGB / 06082015
- Conditions
- Morbid Obesity, Postoperative Complications, Weight Loss
- Keywords
- gastric bypass, hospital charges, mini gastric bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 May 2016 (estimated)
- 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 try to identify differences in cost, length of operation and results between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the Single anastomosis laparoscopic gastric bypass. The study will be conducted in a Spanish public health system hospital.
The patients of the trial will have the preoperative studies, hospital treatment during the admission, postoperative treatment and follow up as any other patient included in the hospital bariatric surgery program. No new methods are applied other than randomly choose the surgical technique.
Patients will be randomized in a 1:1 ratio to each group.
Detailed description
One group of patients of the study will have done the simplified laparoscopic gastric bypass, with a vertical gastric pouch of about 20 ml, a 150 cm Roux-en-Y limb constructed in an antegastric antecolic fashion, and a biliary limb of 100 cm. Anastomosis will be done with endoscopic surgical linear stapler, closing the apertures with continuous absorbable running sutures. The Petersen space and the mesenteric defect will be closed with non-absorbable sutures.
The other group of patients will have performed the single anastomosis gastric bypass, also known as the Minigastric bypass (MGB), which have a vertical gastric pouch about 100-150 ml, and an end to side gastro-jejunal anastomosis at 200 cm from Treitz angle. The anastomosis will be done with endoscopic surgical linear stapler, closing the aperture with continuous absorbable running sutures.The Petersen space will be also close with non-absorbable sutures.
The investigators randomly assigned 10 patients to each group, n=20. Considering that one of the methods is basically the same than the other, but for the Roux-en-Y construction, it is expected a clear difference in operating room (OR) time, between groups. Fisher Test, will be used for the statistical analysis, assuming a risk of 0.05 and a statistical power of 90%, and Mann-Whitney test for quantitative parameters.
Once patients were included in the study, they were randomized in a 1:1 ratio to the conventional laparoscopic gastric bypass group or the single-anastomosis laparoscopic gastric bypass (Mini gastric bypass) group and were also blinded to the surgeon until surgery. The method of randomization was concealed envelopes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minigastric bypass | Active comparator | Procedure: Minigastric bypassIntervention(s): The patient will have done a Laparoscopic one anastomosis gastric bypass (minigastric bypass) at the time of the surgical procedure. |
| Gastric bypass | Active comparator | Procedure: Gastric bypassThe patient will have a Laparoscopic Roux-en-Y gastric bypass at the time of the surgical procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
- age between 18-65 years-old.
- BMI between 40-50 kg/m2
- Obesity for more than 5 years of evolution
- Fail in medical supervised weight loss program
Key exclusion criteria (6 listed)
- Patients unable to sign the informed consent form because of a mental disorder.
- endocrine diseases causing obesity
- unstable mental disorder, evaluated for a psychiatry MD.
- high anesthetic risk making surgery too risky.
- Malignant neoplasm
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 |
|---|---|---|
| Minigastric bypassAlso: Single or One anastomosis gastric bypassThe patient will be submitted to a minigastric bypass at the time of the operation | Procedure or surgery | Minigastric bypass |
| Gastric bypassAlso: Laparoscopic gastric bypassIn this case a simplified conventional gastric bypass will be performed | Procedure or surgery | Gastric bypass |
Primary outcome
Hospital Cost in euros
Time frame: up to 3 months
Total hospital expenses during admission for the surgery
Length of operation in minutes
Time frame: 1 day
Duration of the surgical procedure
9 secondary outcomes
weight loss in kilograms
Time frame: 3 months
weight loss in kilograms
Time frame: 6 months
weight loss in kilograms
Time frame: 9 months
weight loss in kilograms
Time frame: 12 months
weight loss in kilograms
Time frame: 18 months
weight loss in kilograms
Time frame: 24 months
weight loss in kilograms
Time frame: 3 years
weight loss in kilograms
Time frame: 4 years
weight loss in kilograms
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 23011462Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
- Background: PubMed 11433900Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
- Background: PubMed 15973097Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.
- Background: PubMed 25056233Lee WJ, Lin YH. Single-anastomosis gastric bypass (SAGB): appraisal of clinical evidence. Obes Surg. 2014 Oct;24(10):1749-56. doi: 10.1007/s11695-014-1369-9.
- Background: PubMed 25661550Piche ME, Auclair A, Harvey J, Marceau S, Poirier P. How to choose and use bariatric surgery in 2015. Can J Cardiol. 2015 Feb;31(2):153-66. doi: 10.1016/j.cjca.2014.12.014. Epub 2014 Dec 15.
- Background: PubMed 25409956Ramos AC, Silva AC, Ramos MG, Canseco EG, Galvao-Neto Mdos P, Menezes Mde A, Galvao TD, Bastos EL. Simplified gastric bypass: 13 years of experience and 12,000 patients operated. Arq Bras Cir Dig. 2014;27 Suppl 1(Suppl 1):2-8. doi: 10.1590/s0102-6720201400s100002.
- Individual participant dataSharing planned: No. The plan is to publish the results of our study in a scientific journal when it be completed, not to publish the individual patient data, just the global data comparing both groups of study.
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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. This study is not recruiting at the moment.
Miguel J Garcia-Oria, MD PhD FACS study chair
Unidad Cirugia Obesidad y Metabolica Hospital Puerta de Hierro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minigastric bypass and Gastric bypass in people with Morbid Obesity and Postoperative Complications, run by Puerta de Hierro University Hospital at 1 site in Spain.
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Cost in euros (time frame: up to 3 months). 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?
On the ClinicalTrials.gov record for NCT02779322, which also lists 6 linked publications.
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 21 Apr 2020.