Compares two bariatric surgery methods for severe obesity
Compares two gastric bypass surgeries in adults with severe obesity, one with a mesh band.
Plain-language title generated from the registry record
Registry title: Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial
Key facts
- Where
- Majadahonda, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT02939664, who can take part
Where in Spain
- Servicio de Cirugía General. Hospital Universitario Puerta de Hierro MajadahondaMajadahonda, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Puerta de Hierro University Hospital
- Trial code
- NCT02939664
- Record updated
- 21 April 2020
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: high anesthetic risk making surgery too risky; 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; 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; 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.