Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Procedure: long-limb gastric bypass; Procedure: distal gastric bypass

• Registration Number: NCT00821197
• Lead Sponsor: Oslo University Hospital

Brief Summary

The main study objective:

To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).

The main study hypothesis:

Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.

Detailed Description

Technical data will later be published in detail

Study Timeline

• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Study Start: 2011-02
• Primary Completion: 2015-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• BMI 50 - 60 kg/m2 at admission for evaluation for bariatric surgery
• BMI 48 - 62 kg/m2 at study inclusion
• informed consent
• scheduled for bariatric surgery

Exclusion Criteria

• previous bariatric surgery
• previous major abdominal surgery
• previous history or established urolithiasis
• viral hepatitis, liver cirrhosis of any kind
• factors making the patient not eligible to understand and commit to the study protocol (severe psychiatric disease or drug/narcotic abuse)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
long-limb bypass	long-limb gastric bypass	Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Distal gastric bypass	distal gastric bypass	Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

Primary Outcome Measures

Name	Time	Method
Primary outcome: weight loss	2 years postoperatively	physical examination

Secondary Outcome Measures

Name	Time	Method
Health related Quality of life	10 years postoperative	questionnaire
Secondary outcome: Quality of life	2 years postoperative	questionnaire
Adverse events	10 years postoperative	Medical history, journals
Number of patients with vitamin deficiencies	10 years postoperative	Blood samples
Number of patients with mineral deficiencies	10 years postoperative	Blood samples
Number of participants with malnutrition	2 years postoperative	Blood samples
Weight loss 5 year	5 year postoperative	physical examination
Number of patients with malnutrition	10 years postoperative	Blood samples
Weight loss 10 years	10 years postoperative	Weight measure

Trial Locations

Locations (1)

Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.; 🇳🇴 Oslo, Norway