Weight Loss Clinical Trial
— LGB-vs-LbGBOfficial title:
Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass, a Randomized Prospective Clinical Trial
Verified date | April 2020 |
Source | Puerta de Hierro University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | January 2034 |
Est. primary completion date | January 2034 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid |
Lead Sponsor | Collaborator |
---|---|
Puerta de Hierro University Hospital |
Spain,
Arceo-Olaiz R, España-Gómez MN, Montalvo-Hernández J, Velázquez-Fernández 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. — View 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. Epub 2007 Jun 4. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation
Zarate X, Arceo-Olaiz R, Montalvo Hernandez J, García-García 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from operation date, in excess weight loss at 10 years | % of excess weight loss at 10 years | 10 years | |
Primary | 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 | Excess weight loss at 5 years | % of excess weight loss at 5 years | 5 years | |
Secondary | Total Hospital cost at 3 months | Total hospital expenses during admission for the surgery and 3 months after the operation. | up to 3 months | |
Secondary | Postoperative complications 1 year | Number of participants with adverse events (surgical complications) | 1 year | |
Secondary | Postoperative complications 2 years | Number of participants with adverse events (surgical complications) | 2 years | |
Secondary | Postoperative complications 3 years | Number of participants with adverse events (surgical complications) | 3 years | |
Secondary | Postoperative complications 5 years | Number of participants with adverse events (surgical complications) | 5 years |
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