Long or Very Long-Limb Gastric Bypass in Superobese

Kaunas University of Medicine

Status and phase: Unknown; Phase 3

Conditions: Obesity

Treatments: Procedure: laparoscopic gastric Roux-en-Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT00868543

BE-2-37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Long limb

Active Comparator group

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

Treatment:

Procedure: laparoscopic gastric Roux-en-Y gastric bypass

Very long limb

Active Comparator group

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

Treatment:

Procedure: laparoscopic gastric Roux-en-Y gastric bypass