Back to resultsLong-limb or Distal Gastric Bypass for Superobesity - Randomized Study
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
long-limb gastric bypass
distal gastric bypass
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, laparoscopy, bariatric, super obesity
Eligibility Criteria
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)
Sites / Locations
- Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
long-limb bypass
Distal gastric bypass
Arm Description
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
Outcomes
Primary Outcome Measures
Primary outcome: weight loss
physical examination
Secondary Outcome Measures
Secondary outcome: Quality of life
questionnaire
Adverse events
medical history, journals
Number of patients with vitamin deficiencies
Blood samples
Number of patients with mineral deficiencies
Blood samples
Number of participants with malnutrition
Blood samples
Weight loss 5 year
physical examination
Health related Quality of life
questionnaire
Number of patients with malnutrition
Blood samples
Number of patients with mineral deficiencies
Blood samples
Number of patients with vitamin deficiencies
Blood samples
Adverse events
Medical history, journals
Weight loss 10 years
Weight measure
Adverse events
Medical history, journals
Number of patients with malnutrition
Blood samples
Number of patients with mineral deficiencies
Blood samples
Number of patients with vitamin deficiencies
Blood samples
Health related Quality of life
questionnaire
Full Information
NCT ID
NCT00821197
First Posted
January 12, 2009
Last Updated
September 3, 2021
Sponsor
Oslo University Hospital
Collaborators
The Hospital of Vestfold
1. Study Identification
Unique Protocol Identification Number
NCT00821197
Brief Title
Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study
Official Title
Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
The Hospital of Vestfold
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, laparoscopy, bariatric, super obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
long-limb bypass
Arm Type
Active Comparator
Arm Description
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Arm Title
Distal gastric bypass
Arm Type
Active Comparator
Arm Description
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
Intervention Type
Procedure
Intervention Name(s)
long-limb gastric bypass
Intervention Description
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Intervention Type
Procedure
Intervention Name(s)
distal gastric bypass
Intervention Description
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
Primary Outcome Measure Information:
Title
Primary outcome: weight loss
Description
physical examination
Time Frame
2 years postoperatively
Secondary Outcome Measure Information:
Title
Secondary outcome: Quality of life
Description
questionnaire
Time Frame
2 years postoperative
Title
Adverse events
Description
medical history, journals
Time Frame
2 years postoperative
Title
Number of patients with vitamin deficiencies
Description
Blood samples
Time Frame
2 years postoperative
Title
Number of patients with mineral deficiencies
Description
Blood samples
Time Frame
2 years postoperative
Title
Number of participants with malnutrition
Description
Blood samples
Time Frame
2 years postoperative
Title
Weight loss 5 year
Description
physical examination
Time Frame
5 year postoperative
Title
Health related Quality of life
Description
questionnaire
Time Frame
5 years postoperative
Title
Number of patients with malnutrition
Description
Blood samples
Time Frame
5 years postoperative
Title
Number of patients with mineral deficiencies
Description
Blood samples
Time Frame
5 years postoperative
Title
Number of patients with vitamin deficiencies
Description
Blood samples
Time Frame
5 years postoperative
Title
Adverse events
Description
Medical history, journals
Time Frame
5 years
Title
Weight loss 10 years
Description
Weight measure
Time Frame
10 years postoperative
Title
Adverse events
Description
Medical history, journals
Time Frame
10 years postoperative
Title
Number of patients with malnutrition
Description
Blood samples
Time Frame
10 years postoperative
Title
Number of patients with mineral deficiencies
Description
Blood samples
Time Frame
10 years postoperative
Title
Number of patients with vitamin deficiencies
Description
Blood samples
Time Frame
10 years postoperative
Title
Health related Quality of life
Description
questionnaire
Time Frame
10 years postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Mala MD, PhD Rune Sandbu, MD, PhD
Organizational Affiliation
Aker University Hospital / The Hospital of Vestfold
Official's Role
Study Chair
Facility Information:
Facility Name
Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
City
Oslo
ZIP/Postal Code
0514
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
34791048
Citation
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.
Results Reference
derived
PubMed Identifier
31065919
Citation
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.
Results Reference
derived
PubMed Identifier
28865057
Citation
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.
Results Reference
derived
PubMed Identifier
27626242
Citation
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.
Results Reference
derived
PubMed Identifier
25761943
Citation
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.
Results Reference
derived
Links:
URL
http://www.aus.no/
Description
hospital site
URL
http://www.siv.no
Description
hospital site
Learn more about this trial
Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study
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