Long or Very Long-Limb Gastric Bypass in Superobese

Obesity Clinical Trial

Official title:

Long or Very Long-Limb Gastric Bypass in Superobese

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00868543
• Other study ID #: BE-2-37
• Status: Recruiting
• Phase: Phase 3
• First received: March 24, 2009
• Last updated: March 24, 2009
• Start date: July 2008
• Est. completion date: December 2015

Study information

• Verified date: March 2009
• Source: Kaunas University of Medicine
• Contact: Nerijus Kaselis
• Phone: +37069943431
• Email: nkaselis[@]gmail.com
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• laparoscopic 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.
• laparoscopic 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 250cm 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.

Locations

Country	Name	City	State
Lithuania	KMUK, surgery department	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Kaunas University of Medicine

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss- we will compare percentage of excess body weight loss (%EWL) between groups.		7 years	Yes
Secondary	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	Yes