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Long or Very Long-Limb Gastric Bypass in Superobese

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 3
Locations
Lithuania
Study Type
Interventional
Intervention
laparoscopic gastric Roux-en-Y gastric bypass
laparoscopic gastric Roux-en-Y gastric bypass
Sponsored by
Kaunas University of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Gastric bypass, obesity, superobese

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KMUK, surgery departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Long limb

Very long limb

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
March 24, 2009
Last Updated
March 24, 2009
Sponsor
Kaunas University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00868543
Brief Title
Long or Very Long-Limb Gastric Bypass in Superobese
Official Title
Long or Very Long-Limb Gastric Bypass in Superobese
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kaunas University of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Gastric bypass, obesity, superobese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long limb
Arm Type
Active Comparator
Arm Description
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
Arm Title
Very long limb
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
laparoscopic gastric Roux-en-Y gastric bypass
Other Intervention Name(s)
laparoscopic gastric bypass
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic gastric Roux-en-Y gastric bypass
Other Intervention Name(s)
laparoscopic gastric bypass
Intervention Description
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.
Primary Outcome Measure Information:
Title
weight loss- we will compare percentage of excess body weight loss (%EWL) between groups.
Time Frame
7 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nerijus Kaselis
Phone
+37069943431
Email
nkaselis@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Almantas Maleckas
Phone
+37068531143
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Almantas Maleckas
Organizational Affiliation
Kaunas University of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
KMUK, surgery department
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nerijus Kaselis
Phone
+37069943431
Email
nkaselis@gmail.com
First Name & Middle Initial & Last Name & Degree
Nerijus Kaselis

12. IPD Sharing Statement

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