Clinical trial

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

Invitation only · Not applicable · 1 countries · Registry ID NCT02939664

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionMorbid Obesity, Weight Loss, Postoperative Complications

Full registry 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.

Treatments and study arms

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.

Gastric bypass

Procedure

In this case a simplified conventional gastric bypass will be performed

Primary outcomes

Change from operation date, in excess weight loss at 10 years10 years

% of excess weight loss at 10 years

Postoperative complications at 10 years10 years

Number of participants with adverse events (surgical complications) and/or abnormal Laboratory values that are related to treatment

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda🇪🇸 Majadahonda, Madrid, Spain

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