Long or Very Long-Limb Gastric Bypass in Superobese

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2009 by Kaunas University of Medicine
Sponsor:
Information provided by:
Kaunas University of Medicine
ClinicalTrials.gov Identifier:
NCT00868543
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Obesity
Procedure: laparoscopic gastric Roux-en-Y gastric bypass
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Long or Very Long-Limb Gastric Bypass in Superobese

Resource links provided by NLM:


Further study details as provided by Kaunas University of Medicine:

Primary Outcome Measures:
  • weight loss- we will compare percentage of excess body weight loss (%EWL) between groups. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Long limb
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
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.
Other Name: laparoscopic gastric bypass
Active Comparator: Very long limb
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
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.
Other Name: laparoscopic gastric bypass

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868543

Contacts
Contact: Nerijus Kaselis +37069943431 nkaselis@gmail.com
Contact: Almantas Maleckas +37068531143

Locations
Lithuania
KMUK, surgery department Recruiting
Kaunas, Lithuania, 50009
Contact: Nerijus Kaselis    +37069943431    nkaselis@gmail.com   
Principal Investigator: Nerijus Kaselis         
Sponsors and Collaborators
Kaunas University of Medicine
Investigators
Principal Investigator: Almantas Maleckas Kaunas University of Medicine
  More Information

No publications provided

Responsible Party: Almantas Maleckas, Kaunas University of Medicine
ClinicalTrials.gov Identifier: NCT00868543     History of Changes
Other Study ID Numbers: BE-2-37
Study First Received: March 24, 2009
Last Updated: March 24, 2009
Health Authority: Lithuania: Bioethics Committee

Keywords provided by Kaunas University of Medicine:
Gastric bypass
obesity
superobese

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014