NCT02939664Enrolling by invitation
Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial
Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass, a Randomized Prospective Clinical Trial
Source: ClinicalTrials.gov · Last updated 21 Apr 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Sept 2016
- Start date
- Apr 2016
- Primary completion date
- Jan 2034
- Lead sponsor
- Puerta de Hierro University Hospital
- Diseases
- Obesity
- NCT number
- NCT02939664
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Apr 2016 to the primary completion date, Jan 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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)
Other
- abdominal wall hernias
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.