Banded (with polypropylene mesh) gastric bypass: 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.
Gastric bypass: In this case a simplified conventional gastric bypass will be performed
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)
Change from operation date, in excess weight loss at 10 years — 10 years % of excess weight loss at 10 years
Postoperative complications at 10 years — 10 years Number of participants with adverse events (surgical complications) and/or abnormal Laboratory values that are related to treatment
Trial sites (1)
Facility
City
Region
Status
Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Madrid
More Puerta de Hierro University Hospital trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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