NCT00821197

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
2.1 years until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

4.2 years

First QC Date

January 12, 2009

Last Update Submit

September 3, 2021

Conditions

Obesity

Keywords

obesitylaparoscopybariatricsuper obesity

Outcome Measures

Primary Outcomes (1)

  • Primary outcome: weight loss

    physical examination

    2 years postoperatively

Secondary Outcomes (17)

  • Secondary outcome: Quality of life

    2 years postoperative

  • Adverse events

    2 years postoperative

  • Number of patients with vitamin deficiencies

    2 years postoperative

  • Number of patients with mineral deficiencies

    2 years postoperative

  • Number of participants with malnutrition

    2 years postoperative

  • +12 more secondary outcomes

Study Arms (2)

long-limb bypass

ACTIVE COMPARATOR

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

Procedure: long-limb gastric bypass

Distal gastric bypass

ACTIVE COMPARATOR

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

Procedure: distal gastric bypass

Interventions

long-limb gastric bypassPROCEDURE

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

long-limb bypass
distal gastric bypassPROCEDURE

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

Distal gastric bypass

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 50 - 60 kg/m2 at admission for evaluation for bariatric surgery
  • informed consent
  • scheduled for bariatric surgery

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.

Oslo, 0514, Norway

Location

Related Publications (6)

  • Salte OB, Hagen RE, Svanevik M, Fagerland MW, Risstad H, Hjelmesaeth J, Kristinsson JA, Sandbu R, Mala T. Effect of standard versus long alimentary limb distal Roux-en-Y gastric bypass on weight loss and nutritional outcomes at 10 years in patients with BMI 50-60 kg/m2-a secondary analysis of a randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf285. doi: 10.1093/bjs/znaf285.

    PMID: 41553109DERIVED

  • 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.

    PMID: 34791048DERIVED

  • 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.

    PMID: 31065919DERIVED

  • 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.

    PMID: 28865057DERIVED

  • 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.

    PMID: 27626242DERIVED

  • 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.

    PMID: 25761943DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tom Mala MD, PhD Rune Sandbu, MD, PhD

    Aker University Hospital / The Hospital of Vestfold

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator Surgeon phd Tom Mala Rune Sandbu

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 13, 2009

Study Start

February 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2025

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations

NO(1)