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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Procedure: long-limb gastric bypass; Procedure: distal gastric bypass

Detailed Description

Technical data will later be published in detail

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0514
    • Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: long-limb bypass; Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)	Procedure: long-limb gastric bypass; Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Active Comparator: Distal gastric bypass; Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)	Procedure: distal gastric bypass; Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome: weight loss	physical examination	2 years postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: The Hospital of Vestfold
• Investigators: Study Chair: Tom Mala MD, PhD Rune Sandbu, MD, PhD, Aker University Hospital / The Hospital of Vestfold

Publications and helpful links

General Publications

• Salte OBK, Svanevik M, Risstad H, Hofso D, Blom-Hogestol IK, Johnson LK, Fagerland MW, Kristinsson J, Hjelmesaeth J, Mala T, Sandbu R. Standard versus distal Roux-en-Y gastric bypass in patients with BMI 50-60 kg/m2: 5-year outcomes of a double-blind, randomized clinical trial. BJS Open. 2021 Nov 9;5(6):zrab105. doi: 10.1093/bjsopen/zrab105.
• Svanevik M, Risstad H, Hofso D, Blom-Hogestol IK, Kristinsson JA, Sandbu R, Smastuen MC, Thorsby PM, Mala T, Hjelmesaeth J. Bone Turnover Markers After Standard and Distal Roux-en-Y Gastric Bypass: Results from a Randomized Controlled Trial. Obes Surg. 2019 Sep;29(9):2886-2895. doi: 10.1007/s11695-019-03909-1.
• Svanevik M, Risstad H, Karlsen TI, Kristinsson JA, Smastuen MC, Kolotkin RL, Sovik TT, Sandbu R, Mala T, Hjelmesaeth J. Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial. Obes Surg. 2018 Mar;28(3):606-614. doi: 10.1007/s11695-017-2891-3.
• Risstad H, Svanevik M, Kristinsson JA, Hjelmesaeth J, Aasheim ET, Hofso D, Sovik TT, Karlsen TI, Fagerland MW, Sandbu R, Mala T. Standard vs Distal Roux-en-Y Gastric Bypass in Patients With Body Mass Index 50 to 60: A Double-blind, Randomized Clinical Trial. JAMA Surg. 2016 Dec 1;151(12):1146-1155. doi: 10.1001/jamasurg.2016.2798.
• Svanevik M, Risstad H, Hofso D, Schou CF, Solheim B, Sovik TT, Kristinsson J, Hjelmesaeth J, Mala T, Sandbu R. Perioperative Outcomes of Proximal and Distal Gastric Bypass in Patients with BMI Ranged 50-60 kg/m(2)--A Double-Blind, Randomized Controlled Trial. Obes Surg. 2015 Oct;25(10):1788-95. doi: 10.1007/s11695-015-1621-y.

Helpful Links

• hospital site
• hospital site

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2015
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: January 12, 2009
• First Submitted That Met QC Criteria: January 12, 2009
• First Posted (Estimate): January 13, 2009

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: obesity; laparoscopy; bariatric; super obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: AT-0910-ST