NCT00327912

Brief Summary

The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index \[BMI\] \> 50 kg/m2).

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 obesity

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_4 obesity

Geographic Reach
2 countries

2 active sites

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

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

11.7 years

First QC Date

May 18, 2006

Last Update Submit

February 1, 2017

Conditions

ObesityDiabetesHypertension

Keywords

ObesitySurgeryGastric bypassBiliopancreatic diversion with Duodenal switchLaparoscopy

Outcome Measures

Primary Outcomes (3)

  • BMI

    5 y

  • Metabolic normalization

    5y

  • Gastro-intestinal side effects

    5y

Secondary Outcomes (5)

  • Health economics

    5y

  • Vitamin/mineral deficiencies

    5y

  • Body composition

    5y

  • Quality of life

    5y

  • Eating pattern

    5y

Study Arms (2)

1

EXPERIMENTAL

Laparoscopic Biliopancreatic diversion with Duodenal switch

Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch

2

ACTIVE COMPARATOR

Laparoscopic Roux-en-Y Gastric Bypass

Procedure: Laparoscopic Roux-en-Y Gastric Bypass

Interventions

Laparoscopic Biliopancreatic diversion with Duodenal switchPROCEDURE
1
Laparoscopic Roux-en-Y Gastric BypassPROCEDURE
2

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 50-60 kg/m2

You may not qualify if:

  • Prior obesity operation
  • Prior major abdominal surgical procedure
  • Severe disabling cardiopulmonary disease
  • Malignancy
  • Oral steroid treatment
  • Condition associated with poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Surgery, Aker University Hospital

Oslo, Oslo County, Norway

Location

Dept of Surgery, Sahlgrenska University Hospital

Gothenburg, Gothenburg, 41345, Sweden

Location

Related Publications (5)

  • Salte OBK, Olbers T, Risstad H, Fagerland MW, Sovik TT, Blom-Hogestol IK, Kristinsson JA, Engstrom M, Mala T. Ten-Year Outcomes Following Roux-en-Y Gastric Bypass vs Duodenal Switch for High Body Mass Index: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414340. doi: 10.1001/jamanetworkopen.2024.14340.

    PMID: 38829616DERIVED

  • Risstad H, Sovik TT, Engstrom M, Aasheim ET, Fagerland MW, Olsen MF, Kristinsson JA, le Roux CW, Bohmer T, Birkeland KI, Mala T, Olbers T. Five-year outcomes after laparoscopic gastric bypass and laparoscopic duodenal switch in patients with body mass index of 50 to 60: a randomized clinical trial. JAMA Surg. 2015 Apr;150(4):352-61. doi: 10.1001/jamasurg.2014.3579.

    PMID: 25650964DERIVED

  • Sovik TT, Aasheim ET, Taha O, Engstrom M, Fagerland MW, Bjorkman S, Kristinsson J, Birkeland KI, Mala T, Olbers T. Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Ann Intern Med. 2011 Sep 6;155(5):281-91. doi: 10.7326/0003-4819-155-5-201109060-00005.

    PMID: 21893621DERIVED

  • Sovik TT, Taha O, Aasheim ET, Engstrom M, Kristinsson J, Bjorkman S, Schou CF, Lonroth H, Mala T, Olbers T. Randomized clinical trial of laparoscopic gastric bypass versus laparoscopic duodenal switch for superobesity. Br J Surg. 2010 Feb;97(2):160-6. doi: 10.1002/bjs.6802.

    PMID: 20035530DERIVED

  • Aasheim ET, Bjorkman S, Sovik TT, Engstrom M, Hanvold SE, Mala T, Olbers T, Bohmer T. Vitamin status after bariatric surgery: a randomized study of gastric bypass and duodenal switch. Am J Clin Nutr. 2009 Jul;90(1):15-22. doi: 10.3945/ajcn.2009.27583. Epub 2009 May 13.

    PMID: 19439456DERIVED

MeSH Terms

Conditions

ObesityDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hans H Lönroth, MD, PhD

    Sahlgrenska University Hospital

    STUDY CHAIR

  • Tom Mala, MD, PhD

    Aker University Hospital, Oslo, Norway

    STUDY CHAIR

  • Jon Kristinsson, MD, PhD

    Aker University Hospital, Oslo, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2006

First Posted

May 19, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

NO(1)SE(1)