Long or Very Long-Limb Gastric Bypass in Superobese

NCT00868543 | Unknown Phase 3

• 1 other identifier: BE-2-37
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Gastric bypass; obesity; superobese

Outcome Measures

Primary Outcomes (1)

• weight loss- we will compare percentage of excess body weight loss (%EWL) between groups.

  7 years

Secondary Outcomes (1)

• 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

Study Arms (2)

Long limb

ACTIVE COMPARATOR

Hospitalized male or female subjects 18-65 years of age,obese with body mass index (BMI= kg/m²)\>50.Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition, who read the informed consent form and gave a written consent to participate in the study. Gastric bypass was performed with long (150 cm) alimentary Roux limb

Procedure: laparoscopic gastric Roux-en-Y gastric bypass

Very long limb

ACTIVE COMPARATOR

Hospitalized male or female subjects 18-65 years of age,obese with body mass index (BMI= kg/m²)\>50.Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition, who read the informed consent form and gave a written consent to participate in the study. Gastric bypass was performed with very long (250 cm) alimentary Roux limb

Procedure: laparoscopic gastric Roux-en-Y gastric bypass

Interventions

laparoscopic gastric Roux-en-Y gastric bypass PROCEDURE

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.

Also known as: laparoscopic gastric bypass

Long limb

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaunas University of Medicine: lead

Study Sites (1)

KMUK, surgery department

Kaunas, 50009, Lithuania

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Almantas Maleckas

  Kaunas University of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nerijus Kaselis

CONTACT

+37069943431; nkaselis@gmail.com

Almantas Maleckas

CONTACT

+37068531143

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2015
• Last Updated: March 25, 2009

Record last verified: 2009-03

Locations

LI (1)