Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study
NCT ID: NCT00821197
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
115 participants
INTERVENTIONAL
2011-02-28
2025-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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long-limb bypass
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
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)
distal gastric bypass
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* BMI 48 - 62 kg/m2 at study inclusion
* informed consent
* scheduled for bariatric surgery
Exclusion Criteria
* 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)
20 Years
60 Years
ALL
No
Sponsors
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The Hospital of Vestfold
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Tom Mala
Principal investigator Surgeon phd Tom Mala Rune Sandbu
Principal Investigators
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Tom Mala MD, PhD Rune Sandbu, MD, PhD
Role: STUDY_CHAIR
Aker University Hospital / The Hospital of Vestfold
Locations
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Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
Oslo, , Norway
Countries
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References
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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.
Related Links
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hospital site
hospital site
Other Identifiers
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AT-0910-ST
Identifier Type: -
Identifier Source: org_study_id
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