Clinical trial NCT00821197: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obesity
laparoscopy
bariatric
super obesity
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Hospital of Vestfold
First posted: 2009-01-13
Enrollment: 115
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Primary outcome: weight loss
timeFrame: 2 years postoperatively
Secondary outcomes:
measure: Secondary outcome: Quality of life
timeFrame: 2 years postoperative
measure: Adverse events
timeFrame: 2 years postoperative
measure: Number of patients with vitamin deficiencies
timeFrame: 2 years postoperative
measure: Number of patients with mineral deficiencies
timeFrame: 2 years postoperative
measure: Number of participants with malnutrition
timeFrame: 2 years postoperative
measure: Weight loss 5 year
timeFrame: 5 year postoperative
measure: Health related Quality of life
timeFrame: 5 years postoperative
measure: Number of patients with malnutrition
timeFrame: 5 years postoperative
measure: Number of patients with mineral deficiencies
timeFrame: 5 years postoperative
measure: Number of patients with vitamin deficiencies
timeFrame: 5 years postoperative
measure: Adverse events
timeFrame: 5 years
measure: Weight loss 10 years
timeFrame: 10 years postoperative
measure: Adverse events
timeFrame: 10 years postoperative
measure: Number of patients with malnutrition
timeFrame: 10 years postoperative
measure: Number of patients with mineral deficiencies
timeFrame: 10 years postoperative
measure: Number of patients with vitamin deficiencies
timeFrame: 10 years postoperative
measure: Health related Quality of life
timeFrame: 10 years postoperative
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
Study officials:
affiliation: Aker University Hospital / The Hospital of Vestfold
name: Tom Mala MD, PhD Rune Sandbu, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.