![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
Kaunas University of Medicine |
---|---|
Information provided by: | Kaunas University of Medicine |
ClinicalTrials.gov Identifier: | NCT00868543 |
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 |
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 |
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.
|
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:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nerijus Kaselis | +37069943431 | nkaselis@gmail.com |
Contact: Almantas Maleckas | +37068531143 |
Lithuania | |
KMUK, surgery department | Recruiting |
Kaunas, Lithuania, 50009 | |
Contact: Nerijus Kaselis +37069943431 nkaselis@gmail.com | |
Principal Investigator: Nerijus Kaselis |
Principal Investigator: | Almantas Maleckas | Kaunas University of Medicine |
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 |
Gastric bypass obesity superobese |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |