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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Gastric Bypass. | Active Comparator | The patient will have done a Laparoscopic Roux-en-Y gastric bypass at the time of the surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Banded (with polypropylene mesh) gastric bypass | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from operation date, in excess weight loss at 10 years | % of excess weight loss at 10 years | 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 | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Excess weight loss at 5 years | % of excess weight loss at 5 years | 5 years |
| Total Hospital cost at 3 months | Total hospital expenses during admission for the surgery and 3 months after the operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel J Garcia-Oria, MD PhD FACS | General Surgery Department. Hospital Universitario Puerta de Hierro | Study Chair |
| Miguel J Garcia-Oria, MD PhD | Servicio de CirugÃa General. Hospital Universitario Puerta de Hierro Majadahonda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de CirugÃa General. Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18226982 | Background | 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. | |
| 17544335 | Background |
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We will publish the results of the study in a surgical journal
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|
| Gastric bypass | Procedure | In this case a simplified conventional gastric bypass will be performed |
|
|
| up to 3 months |
| Postoperative complications 1 year | Number of participants with adverse events (surgical complications) | 1 year |
| Postoperative complications 2 years | Number of participants with adverse events (surgical complications) | 2 years |
| Postoperative complications 3 years | Number of participants with adverse events (surgical complications) | 3 years |
| Postoperative complications 5 years | Number of participants with adverse events (surgical complications) | 5 years |
| Bessler 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. |
| 25001288 | Background | Buchwald 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. |
| 11918873 | Background | Capella 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. |
| 8554155 | Background | Capella 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. |
| 24968745 | Background | Mahawar 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. |
| 26314349 | Background | Rasera 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. |
| 23260801 | Background | Zarate 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. |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
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