Clinical trial NCT00868543: Long or Very Long-Limb Gastric Bypass in Superobese
Official title: Long or Very Long-Limb Gastric Bypass in Superobese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obesity
Keywords: Gastric bypass
obesity
superobese
Lead sponsor: Kaunas University of Medicine
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: weight loss- we will compare percentage of excess body weight loss (%EWL) between groups.
timeFrame: 7 years
Secondary outcomes:
measure: 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.
timeFrame: 7 years
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: KMUK, surgery department
Study officials:
affiliation: Kaunas University of Medicine
name: Almantas Maleckas
role: PRINCIPAL_INVESTIGATOR
References: