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

Conditions

Obesity

Keywords

obesity, laparoscopy, bariatric, super obesity

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

Salte OB, Hagen RE, Svanevik M, Fagerland MW, Risstad H, Hjelmesæth J, Kristinsson JA, Sandbu R, Mala T.

2025-12-01

10.1093/bjs/znaf285

Standard <i>versus</i> distal Roux-en-Y gastric bypass in patients with BMI 50–60 kg/m2: 5-year outcomes of a double-blind, randomized clinical trial

Odd Bjørn Salte, Marius Svanevik, Hilde Risstad, Dag Hofsø, Ingvild Kristine Blom-Høgestøl et al. (11 authors)

BJS Open2021-09-2112 citations

10.1093/bjsopen/zrab105

Bone Turnover Markers After Standard and Distal Roux-en-Y Gastric Bypass: Results from a Randomized Controlled Trial.

Svanevik M, Risstad H, Hofsø D, Blom-Høgestøl IK, Kristinsson JA, Sandbu R, Småstuen MC, Thorsby PM, Mala T, Hjelmesæth J.

2019-09-0111 citations

10.1007/s11695-019-03909-1

Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial.

Svanevik M, Risstad H, Karlsen TI, Kristinsson JA, Småstuen MC, Kolotkin RL, Søvik TT, Sandbu R, Mala T, Hjelmesæth J.

2018-03-016 citations

10.1007/s11695-017-2891-3

Standard vs Distal Roux-en-Y Gastric Bypass in Patients With Body Mass Index 50 to 60

Hilde Risstad, Marius Svanevik, Jon Kristinsson, Jøran Hjelmesæth, Erlend T. Aasheim et al. (11 authors)

JAMA Surgery2016-09-1464 citations

10.1001/jamasurg.2016.2798

Interventions

PROCEDURElong-limb gastric bypass

Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)

PROCEDUREdistal gastric bypass

Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

No

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)

Design outcomes

Primary

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

Secondary

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

Countries

Norway

Outcome results

None listed