Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial

NCT02939664 | Enrolling By Invitation DMC

• 1 other identifier: 04252016Acta07.16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Weight Loss; Postoperative Complications

Keywords

banded gastric bypass; weight loss

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Excess weight loss at 5 years

  5 years

• Total Hospital cost at 3 months

  up to 3 months

• Postoperative complications 1 year

  1 year

• Postoperative complications 2 years

  2 years

• Postoperative complications 3 years

  3 years

Study Arms (2)

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.

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

Procedure: Gastric bypass

Interventions

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.

Also known as: Laparoscopic banded gastric bypass, Laparoscopic Roux-en-Y banded gastric bypass, Laparoscopic Banded Roux-en-Y gastric bypass

Banded Gastric Bypass

Gastric bypass PROCEDURE

In this case a simplified conventional gastric bypass will be performed

Also known as: Laparoscopic Gastric bypass

Gastric Bypass.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (8)

• 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.

  PMID: 18226982 BACKGROUND

• 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.

  PMID: 17544335 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.

  PMID: 25001288 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.

  PMID: 11918873 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.

  PMID: 8554155 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.

  PMID: 24968745 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.

  PMID: 26314349 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.

  PMID: 23260801 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss; Postoperative Complications

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• 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 Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 20, 2016
• Study Start: April 1, 2016
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)