Long or Very Long-Limb Gastric Bypass in Superobese

• ClinicalTrials.gov Identifier: NCT00868543
• Recruitment Status: Unknown
• First Posted: March 25, 2009
• Last Update Posted: March 25, 2009
• Sponsor: Kaunas University of Medicine
• Information provided by: Kaunas University of Medicine

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Procedure: laparoscopic gastric Roux-en-Y gastric bypass	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Long or Very Long-Limb Gastric Bypass in Superobese
• Study Start Date: July 2008
• Estimated Primary Completion Date: July 2013
• Estimated Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. weight loss- we will compare percentage of excess body weight loss (%EWL) between groups. [ Time Frame: 7 years ]

Secondary Outcome Measures :

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. [ Time Frame: 7 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Almantas Maleckas, Kaunas University of Medicine
• ClinicalTrials.gov Identifier: NCT00868543
• Other Study ID Numbers: BE-2-37
• First Posted: March 25, 2009
• Last Update Posted: March 25, 2009
• Last Verified: March 2009

Keywords provided by Kaunas University of Medicine:

Gastric bypass; obesity; superobese

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight