Morbid ObesityLGB-vs-LbGBNCT02939664
Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial
A study testing Banded (with polypropylene mesh) gastric bypass and Gastric bypass in people with Morbid Obesity and Weight Loss, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
This study try to identify differences in length of operation, weight loss and complications, between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the laparoscopic Roux-en-Y banded 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, Weight Loss, Postoperative Complications
- What is being tested?
- Banded (with polypropylene mesh) gastric bypass and Gastric bypass
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Jan 2034
- 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
- criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
- Body mass index (BMI)> 40 and <55 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
- 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
- Inflammatory bowel disease
Show all 11Show fewer
- Severe liver disease
- Digestive disease that makes unwise the bypass technique (mainly gastric illness that may required upper endoscopy for control)
- abdominal wall hernias
- Symptomatic biliary pathology that requires cholechistectomy at the same time of the bariatric surgery
- any known pathology that requieres or recomend simultaneous surgery at the time of the bariatric surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
About this study
Official title: Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass, a Randomized Prospective Clinical Trial
This study try to identify differences in length of operation, weight loss and complications, between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the laparoscopic Roux-en-Y banded 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. The study cases will have placed around the gastric pouch a band of polypropylene mesh, and will be randomly choose between the participants.
Patients will be randomized in a 5/3 (study/control) ratio.
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 laparoscopic Roux-en-Y banded gastric bypass. This technique is identical to the one performed in the other group, but differs in that a polypropylene mesh (10x65 mm) is placed 15 mm proximal to the anastomosis around the gastric pouch, and the gastric pouch is about 15 mm longer.
The investigators randomly assigned 50 patients to the study group (Laparoscopic Roux-en-Y banded gastric bypass) and 30 to the control group (Laparoscopic Roux-en-Y gastric bypass) , n=80, and were also blinded to the surgeon until surgery.
One of the methods is basically the same than the other, but for the placement of the polypropylene mesh around the gastric pouch above the anastomosis, and patient series with Laparoscopic Roux-en-Y banded gastric bypass showed long term better weight loss than other series with not banded gastric bypass, thus it is expected a difference in long term weight loss between groups.
Fisher Test will be used for the statistical analysis, assuming a risk of 0.05 and a statistical power of 90%.
Sample size is calculated considering bibliographic long term weight loss in both groups, which is 82% in the banded group versus 63% in the not banded group. Thus sample size (n): 67, and adjust by loss sample size: 79 (10% expected loss ratio), not being necessary a 1: 1 ratio between cases and controls and requiring no more than 25 controls, A sample size of 50 cases and 30 controls, total n = 80, will be used.
The method of randomization was concealed envelopes.
- Conditions
- Morbid Obesity, Weight Loss, Postoperative Complications
- Being tested
- Banded (with polypropylene mesh) gastric bypass, Gastric bypass
- Keywords
- banded gastric bypass, weight loss
- Medical subject headings
- Obesity, Morbid, Weight Loss, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banded (with polypropylene mesh) gastric bypassDevice
Also called Laparoscopic banded gastric bypass, Laparoscopic Roux-en-Y banded gastric bypass, Laparoscopic Banded Roux-en-Y gastric bypass
The patient will be submitted to a Laparoscopic Roux-en-Y banded gastric bypass at the time of the operation, with a polypropylene mesh around the gastric pouch.
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 |
|---|---|---|
| Banded Gastric Bypass | Active comparator | The patient will have done a laparoscopic Roux-en-Y banded (with polypropylene mesh) gastric bypass at the time of the surgical procedure. Receives: Device: Banded (with polypropylene mesh) gastric bypass |
| Gastric Bypass. | Active comparator | The patient will have done 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.
Change from operation date, in excess weight loss at 10 years
% of excess weight loss at 10 years
Measured: 10 years
Postoperative complications at 10 years
Number of participants with adverse events (surgical complications) and/or abnormal Laboratory values that are related to treatment
Measured: 10 years
Secondary outcomes (6)
Excess weight loss at 5 years
% of excess weight loss at 5 years
Measured: 5 years
Total Hospital cost at 3 months
Total hospital expenses during admission for the surgery and 3 months after the operation.
Measured: up to 3 months
Postoperative complications 1 year
Number of participants with adverse events (surgical complications)
Measured: 1 year
Postoperative complications 2 years
Number of participants with adverse events (surgical complications)
Measured: 2 years
Postoperative complications 3 years
Number of participants with adverse events (surgical complications)
Measured: 3 years
Postoperative complications 5 years
Number of participants with adverse events (surgical complications)
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 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2034 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 80 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, General Surgery Department. Hospital Universitario Puerta de HierroMiguel J Garcia-Oria, MD PhD, Study director, Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939664
- Sponsor's protocol ID
- 04252016Acta07.16
- Acronym
- LGB-vs-LbGB
- Status last verified
- Apr 2020
- First submitted
- 28 Sep 2016
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: We will publish the results of the study in a surgical journal
Publications
Arceo-Olaiz R, Espana-Gomez MN, Montalvo-Hernandez J, Velazquez-Fernandez D, Pantoja JP, Herrera MF. Maximal weight loss after banded and unbanded laparoscopic Roux-en-Y gastric bypass: a randomized controlled trial. Surg Obes Relat Dis. 2008 Jul-Aug;4(4):507-11. doi: 10.1016/j.soard.2007.11.006. Epub 2008 Jan 28.
PubMed 18226982Bessler M, Daud A, Kim T, DiGiorgi M. Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results. Surg Obes Relat Dis. 2007 Jul-Aug;3(4):480-4; discussion 484-5. doi: 10.1016/j.soard.2007.01.010. Epub 2007 Jun 4.
PubMed 17544335Buchwald H, Buchwald JN, McGlennon TW. Systematic review and meta-analysis of medium-term outcomes after banded Roux-en-Y gastric bypass. Obes Surg. 2014 Sep;24(9):1536-51. doi: 10.1007/s11695-014-1311-1.
PubMed 25001288Capella JF, Capella RF. An assessment of vertical banded gastroplasty-Roux-en-Y gastric bypass for the treatment of morbid obesity. Am J Surg. 2002 Feb;183(2):117-23. doi: 10.1016/s0002-9610(01)00871-6.
PubMed 11918873Capella JF, Capella RF. The weight reduction operation of choice: vertical banded gastroplasty or gastric bypass? Am J Surg. 1996 Jan;171(1):74-9. doi: 10.1016/S0002-9610(99)80077-4.
PubMed 8554155Mahawar KK, Parikh C, Carr WR, Jennings N, Balupuri S, Small PK. Primary banded Roux-en-Y gastric bypass: a systematic review. Obes Surg. 2014 Oct;24(10):1771-92. doi: 10.1007/s11695-014-1346-3.
PubMed 24968745Rasera I Jr, Coelho TH, Ravelli MN, Oliveira MR, Leite CV, Naresse LE, Henry MA. A Comparative, Prospective and Randomized Evaluation of Roux-en-Y Gastric Bypass With and Without the Silastic Ring: A 2-Year Follow Up Preliminary Report on Weight Loss and Quality of Life. Obes Surg. 2016 Apr;26(4):762-8. doi: 10.1007/s11695-015-1851-z.
PubMed 26314349Zarate X, Arceo-Olaiz R, Montalvo Hernandez J, Garcia-Garcia E, Pablo Pantoja J, Herrera MF. Long-term results of a randomized trial comparing banded versus standard laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2013 May-Jun;9(3):395-7. doi: 10.1016/j.soard.2012.09.009. Epub 2012 Oct 3.
PubMed 23260801
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
- Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass, a Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02939664
- Acronym / sponsor ID
- LGB-vs-LbGB / 04252016Acta07.16
- Conditions
- Morbid Obesity, Weight Loss, Postoperative Complications
- Keywords
- banded gastric bypass, weight loss
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2034 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 20 Oct 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 length of operation, weight loss and complications, between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the laparoscopic Roux-en-Y banded 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. The study cases will have placed around the gastric pouch a band of polypropylene mesh, and will be randomly choose between the participants.
Patients will be randomized in a 5/3 (study/control) ratio.
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 laparoscopic Roux-en-Y banded gastric bypass. This technique is identical to the one performed in the other group, but differs in that a polypropylene mesh (10x65 mm) is placed 15 mm proximal to the anastomosis around the gastric pouch, and the gastric pouch is about 15 mm longer.
The investigators randomly assigned 50 patients to the study group (Laparoscopic Roux-en-Y banded gastric bypass) and 30 to the control group (Laparoscopic Roux-en-Y gastric bypass) , n=80, and were also blinded to the surgeon until surgery.
One of the methods is basically the same than the other, but for the placement of the polypropylene mesh around the gastric pouch above the anastomosis, and patient series with Laparoscopic Roux-en-Y banded gastric bypass showed long term better weight loss than other series with not banded gastric bypass, thus it is expected a difference in long term weight loss between groups.
Fisher Test will be used for the statistical analysis, assuming a risk of 0.05 and a statistical power of 90%.
Sample size is calculated considering bibliographic long term weight loss in both groups, which is 82% in the banded group versus 63% in the not banded group. Thus sample size (n): 67, and adjust by loss sample size: 79 (10% expected loss ratio), not being necessary a 1: 1 ratio between cases and controls and requiring no more than 25 controls, A sample size of 50 cases and 30 controls, total n = 80, will be used.
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 |
|---|---|---|
| Banded Gastric Bypass | Active comparator | Device: Banded (with polypropylene mesh) gastric bypassThe patient will have done a laparoscopic Roux-en-Y banded (with polypropylene mesh) gastric bypass at the time of the surgical procedure. |
| Gastric Bypass. | Active comparator | Procedure: Gastric bypassThe patient will have done 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 (8 listed)
- criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
- Body mass index (BMI)> 40 and <55 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
Key exclusion criteria (11 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 |
|---|---|---|
| Banded (with polypropylene mesh) gastric bypassAlso: Laparoscopic banded gastric bypass, Laparoscopic Roux-en-Y banded gastric bypass, Laparoscopic Banded Roux-en-Y gastric bypassThe patient will be submitted to a Laparoscopic Roux-en-Y banded gastric bypass at the time of the operation, with a polypropylene mesh around the gastric pouch. | Device | Banded Gastric Bypass |
| Gastric bypassAlso: Laparoscopic Gastric bypassIn this case a simplified conventional gastric bypass will be performed | Procedure or surgery | Gastric Bypass. |
Primary outcome
Change from operation date, in excess weight loss at 10 years
Time frame: 10 years
% of excess weight loss at 10 years
Postoperative complications at 10 years
Time frame: 10 years
Number of participants with adverse events (surgical complications) and/or abnormal Laboratory values that are related to treatment
6 secondary outcomes
Excess weight loss at 5 years
Time frame: 5 years
Total Hospital cost at 3 months
Time frame: up to 3 months
Postoperative complications 1 year
Time frame: 1 year
Postoperative complications 2 years
Time frame: 2 years
Postoperative complications 3 years
Time frame: 3 years
Postoperative complications 5 years
Time frame: 5 years
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 21 Apr 2020.
- Background: PubMed 18226982Arceo-Olaiz R, Espana-Gomez MN, Montalvo-Hernandez J, Velazquez-Fernandez D, Pantoja JP, Herrera MF. Maximal weight loss after banded and unbanded laparoscopic Roux-en-Y gastric bypass: a randomized controlled trial. Surg Obes Relat Dis. 2008 Jul-Aug;4(4):507-11. doi: 10.1016/j.soard.2007.11.006. Epub 2008 Jan 28.
- Background: PubMed 17544335Bessler M, Daud A, Kim T, DiGiorgi M. Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results. Surg Obes Relat Dis. 2007 Jul-Aug;3(4):480-4; discussion 484-5. doi: 10.1016/j.soard.2007.01.010. Epub 2007 Jun 4.
- Background: PubMed 25001288Buchwald H, Buchwald JN, McGlennon TW. Systematic review and meta-analysis of medium-term outcomes after banded Roux-en-Y gastric bypass. Obes Surg. 2014 Sep;24(9):1536-51. doi: 10.1007/s11695-014-1311-1.
- Background: PubMed 11918873Capella JF, Capella RF. An assessment of vertical banded gastroplasty-Roux-en-Y gastric bypass for the treatment of morbid obesity. Am J Surg. 2002 Feb;183(2):117-23. doi: 10.1016/s0002-9610(01)00871-6.
- Background: PubMed 8554155Capella JF, Capella RF. The weight reduction operation of choice: vertical banded gastroplasty or gastric bypass? Am J Surg. 1996 Jan;171(1):74-9. doi: 10.1016/S0002-9610(99)80077-4.
- Background: PubMed 24968745Mahawar KK, Parikh C, Carr WR, Jennings N, Balupuri S, Small PK. Primary banded Roux-en-Y gastric bypass: a systematic review. Obes Surg. 2014 Oct;24(10):1771-92. doi: 10.1007/s11695-014-1346-3.
- Background: PubMed 26314349Rasera I Jr, Coelho TH, Ravelli MN, Oliveira MR, Leite CV, Naresse LE, Henry MA. A Comparative, Prospective and Randomized Evaluation of Roux-en-Y Gastric Bypass With and Without the Silastic Ring: A 2-Year Follow Up Preliminary Report on Weight Loss and Quality of Life. Obes Surg. 2016 Apr;26(4):762-8. doi: 10.1007/s11695-015-1851-z.
- Background: PubMed 23260801Zarate X, Arceo-Olaiz R, Montalvo Hernandez J, Garcia-Garcia E, Pablo Pantoja J, Herrera MF. Long-term results of a randomized trial comparing banded versus standard laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2013 May-Jun;9(3):395-7. doi: 10.1016/j.soard.2012.09.009. Epub 2012 Oct 3.
- Individual participant dataSharing planned: No. We will publish the results of the study in a surgical journal
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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.
Miguel J Garcia-Oria, MD PhD FACS study chair
General Surgery Department. Hospital Universitario Puerta de Hierro
Miguel J Garcia-Oria, MD PhD study director
Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Banded (with polypropylene mesh) gastric bypass and Gastric bypass in people with Morbid Obesity and Weight Loss, 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 8 inclusion and 11 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: enrolling by invitation, 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?
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?
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?
Change from operation date, in excess weight loss at 10 years (time frame: 10 years). 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 NCT02939664, which also lists 8 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.