Obesity
Conditions
Keywords
Gastric bypass, obesity, superobese
Brief summary
The goal of this study is to compare the clinical efficacy (weight loss and metabolic changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in superobese (BMI\>50) patients.
Detailed description
The study is a multicentre trial in which superobese (BMI\>50) patients will be randomly assigned (in a 1:1 ratio) for laparoscopic gastric Roux-en-Y gastric bypass with: a) long (150 cm) or b) very long (250cm) alimentary Roux limb. Patients will be included from three hospitals: Kaunas University of Medicine Hospital (Lithuania), Klaipeda District Hospital (Lithuania), Vaasa Central Hospital (Finland) ) where preoperative investigation, the same technique surgical procedures and follow up will be performed acording approved protocol. Approximate duration of subject participation Subjects in the study will participate for approximately 5 years: * Preoperative investigation and surgery 3- 5 days in the hospital; * First follow up visit: 6 months after surgery; * Next follow up visits: 12, 24, 36, 48 months after surgery; * Last follow up visit: 5 years after surgery. * The interim results after 12, 24 and 36 months will be calculated and presented before end of the study.
Interventions
PROCEDURElaparoscopic gastric Roux-en-Y gastric bypass
The fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 150cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis.
Sponsors
Kaunas University of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Hospitalized male or female subjects 18-65 years of age. * Obese subjects with body mass index (BMI= kg/m²)\>50 * Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition. * Patients who read the informed consent form and gave a written consent to participate in the study.
Exclusion criteria
* Previous open abdominal surgery, except appendectomy, cholecystectomy and gynaecological procedures. * Presence of any significance cardiac, hepatic, renal, blood, alimentary tract disease which may lead to system or organ failure in intraoperative or postoperative period. * Pregnant women. * Subjects taking immunosuppressive therapy. * Any concomitant condition that, in the opinion of the investigator, would preclude an operation and postoperative follow up acording to a protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight loss- we will compare percentage of excess body weight loss (%EWL) between groups. | 7 years |
Secondary
| Measure | Time frame |
|---|---|
| To compare body mass index changes and absolute weight loss. To evaluate obesity-related medical problems. To obtain data about impromvement of metabolic syndrom. To compare quality of life changes between treatment arms. | 7 years |
Countries
Lithuania
Contacts
Primary ContactNerijus Kaselis
Backup ContactAlmantas Maleckas
Outcome results
None listed