Long or Very Long-Limb Gastric Bypass in Superobese - Full Text View

Sponsored by:	Kaunas University of Medicine
Information provided by:	Kaunas University of Medicine
ClinicalTrials.gov Identifier:	NCT00868543

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 III

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Long or Very Long-Limb Gastric Bypass in Superobese

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
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 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.
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 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.

Arms

Assigned Interventions

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

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.

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

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.

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

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

Keywords provided by Kaunas University of Medicine:

Gastric bypass
obesity
superobese

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009