NCT00740662

Brief Summary

An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length. At several reoperations we found a length increase of the lowest part of the small intestine of up to 80% compared to the measured length at the initial operation. On the one hand, this reflects a normal technical error of small bowel measuring due to the variable state of contraction of the bowel, but on the other hand, it could also be due to a compensatory increase in intestinal length after the operation. New protocols allow measuring of the small bowel length by MRI. Comparing the preoperative and later on several postoperative measurements by MRI with the initial intraoperative length measuring should allow to validate the new MRI protocol and in the same time quantify the eventual small bowel length increase. We plan to include 20 patients in this study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

January 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

2.5 years

First QC Date

August 22, 2008

Last Update Submit

December 19, 2012

Conditions

Morbid ObesityWeight Loss

Keywords

morbid obesitysmall bowelgastric bypassweight loss

Outcome Measures

Primary Outcomes (1)

  • Small bowel length in vivo compared to measurements by MRI

    preoperative, previous to hospital discharge, 6 and 12 months postoperative

Secondary Outcomes (2)

  • Compensatory increase of the common channel (small bowel) after distal bypass

    12 months postoperative

  • Correlation of longterm weight regain with increase of common channel length

    12 months postoperative

Study Arms (1)

1

Distal gastric bypass

Procedure: Distal gastric bypass

Interventions

Distal gastric bypassPROCEDURE

Distal gastric bypass

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Morbid obese patients scheduled for distal gastric bypass

You may qualify if:

  • morbid obese patient
  • scheduled for distal gastric bypass
  • informed consent for operation and study obtained

You may not qualify if:

  • history of former small bowel resection
  • weight \> 150 kg
  • history of claustrophobia
  • general contraindications for MRI (pacer, joint prosthesis, ear implant, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Visceral and Transplantsurgery, Bern University Hopsital

Bern, 3010, Switzerland

Location

Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (5)

  • Miskowiak J, Andersen B. Intestinal adaptation after jejunoileal bypass for morbid obesity: a possible explanation for inadequate weight loss. Br J Surg. 1983 Jan;70(1):27-8. doi: 10.1002/bjs.1800700110.

    PMID: 6824877BACKGROUND

  • Swaniker F, Guo W, Fonkalsrud EW, Brown T, Newman L, Ament M. Adaptation of rabbit small intestinal brush-border membrane enzymes after extensive bowel resection. J Pediatr Surg. 1995 Jul;30(7):1000-2; discussion 1003. doi: 10.1016/0022-3468(95)90329-1.

    PMID: 7472920BACKGROUND

  • Hughes CA, Ducker DA. Adaptation of the small intestine--does it occur in man? Scand J Gastroenterol Suppl. 1982;74:149-58.

    PMID: 6815778BACKGROUND

  • Wyss M, Froehlich JM, Patak MA, Juli CF, Scheidegger MB, Zollikofer CL, Wentz KU. Gradient-enhanced volume rendering: an image processing strategy to facilitate whole small bowel imaging with MRI. Eur Radiol. 2007 Apr;17(4):1081-8. doi: 10.1007/s00330-006-0472-2. Epub 2006 Oct 5.

    PMID: 17021699BACKGROUND

  • Patak MA, Froehlich JM, von Weymarn C, Breitenstein S, Zollikofer CL, Wentz KU. Non-invasive measurement of small-bowel motility by MRI after abdominal surgery. Gut. 2007 Jul;56(7):1023-5. doi: 10.1136/gut.2007.120816. No abstract available.

    PMID: 17566036BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Jean-Marc Heinicke, MD

    Department of Visceral and Transplant Surgery, Bern University Hospital

    STUDY DIRECTOR

  • Philipp C Nett, Dr

    DRNN, Inselspital, Bern University Hospital, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

CH(2)