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

Obesity Clinical Trial

Official title:

Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00821197
• Other study ID #: AT-0910-ST
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2011
• Est. completion date: May 2025

Study information

• Verified date: September 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Technical data will later be published in detail

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: May 2025
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• long-limb gastric bypass
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
• distal gastric bypass
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

Locations

Country	Name	City	State
Norway	Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The Hospital of Vestfold

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: weight loss	physical examination	2 years postoperatively
Secondary	Secondary outcome: Quality of life	questionnaire	2 years postoperative
Secondary	Adverse events	medical history, journals	2 years postoperative
Secondary	Number of patients with vitamin deficiencies	Blood samples	2 years postoperative
Secondary	Number of patients with mineral deficiencies	Blood samples	2 years postoperative
Secondary	Number of participants with malnutrition	Blood samples	2 years postoperative
Secondary	Weight loss 5 year	physical examination	5 year postoperative
Secondary	Health related Quality of life	questionnaire	5 years postoperative
Secondary	Number of patients with malnutrition	Blood samples	5 years postoperative
Secondary	Number of patients with mineral deficiencies	Blood samples	5 years postoperative
Secondary	Number of patients with vitamin deficiencies	Blood samples	5 years postoperative
Secondary	Adverse events	Medical history, journals	5 years
Secondary	Weight loss 10 years	Weight measure	10 years postoperative
Secondary	Adverse events	Medical history, journals	10 years postoperative
Secondary	Number of patients with malnutrition	Blood samples	10 years postoperative
Secondary	Number of patients with mineral deficiencies	Blood samples	10 years postoperative
Secondary	Number of patients with vitamin deficiencies	Blood samples	10 years postoperative
Secondary	Health related Quality of life	questionnaire	10 years postoperative

External Links

•   hospital site
•   hospital site