Clinical trial NCT02939664: Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial
Official title: Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass, a Randomized Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Morbid Obesity
Weight Loss
Postoperative Complications
Keywords: banded gastric bypass
weight loss
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Change from operation date, in excess weight loss at 10 years
timeFrame: 10 years
measure: Postoperative complications at 10 years
timeFrame: 10 years
Secondary outcomes:
measure: Excess weight loss at 5 years
timeFrame: 5 years
measure: Total Hospital cost at 3 months
timeFrame: up to 3 months
measure: Postoperative complications 1 year
timeFrame: 1 year
measure: Postoperative complications 2 years
timeFrame: 2 years
measure: Postoperative complications 3 years
timeFrame: 3 years
measure: Postoperative complications 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
Study officials:
affiliation: General Surgery Department. Hospital Universitario Puerta de Hierro
name: Miguel J Garcia-Oria, MD PhD FACS
role: STUDY_CHAIR
affiliation: Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda
name: Miguel J Garcia-Oria, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.