- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00740662
Intraoperative Measuring of Small Bowel Length Compared to Measuring by Magnetic Resonance Imaging (MRI) in Morbid Obese Patients
Prospective Study for the Quantification of a Compensatory Increase in Small Bowel Length After Roux-en-Y Gastric Bypass in Morbid Obese Patients by Pre- and Postoperative Length-Measuring With MRI Compared to Intraoperative Length-Measuring
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length in order to define the lengths of the alimentary, biliopancreatic and common channel. The measuring itself is technically simple but has always an error due to the variable state of contraction of the small bowel. In distal gastric bypass a common channel length of 100 to 150 cm is chosen which induces an iatrogenic short bowel syndrome. At several reoperations we found a length increase of the common channel of up to 80% compared to the measured length at the initial operation. Former studies seem to indicate that an adaptation of small bowel length may occur in animals with short bowel syndrome or after intestinal bypass surgery. Longterm results of gastric bypass surgery often show weight regain after 3 to 5 years which could be due to the afore mentioned compensatory mechanism.
Newer MRI protocols allow for non-invasive measurement of the small bowel length. 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.
Objective:
In-vivo verification of small bowel length measurements made by MRI, quantification of a possible increase of the common channel length in the long run after distal gastric bypass.
Methods:
The preoperative small bowel length measurement by MRI is compared to the length measured intraoperatively. MRIs before discharge postoperatively as well as after 6 and 12 months are used to detect an eventual increase of the common channel length.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bern, Switzerland, 3010
- Department of Visceral and Transplantsurgery, Bern University Hopsital
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Bern, Switzerland, 3010
- Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- morbid obese patient
- scheduled for distal gastric bypass
- informed consent for operation and study obtained
Exclusion Criteria:
- history of former small bowel resection
- weight > 150 kg
- history of claustrophobia
- general contraindications for MRI (pacer, joint prosthesis, ear implant, etc.)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Distal gastric bypass
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Distal gastric bypass
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Small bowel length in vivo compared to measurements by MRI
Time Frame: preoperative, previous to hospital discharge, 6 and 12 months postoperative
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preoperative, previous to hospital discharge, 6 and 12 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compensatory increase of the common channel (small bowel) after distal bypass
Time Frame: 12 months postoperative
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12 months postoperative
|
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Correlation of longterm weight regain with increase of common channel length
Time Frame: 12 months postoperative
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12 months postoperative
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Collaborators and Investigators
Investigators
- Study Director: Jean-Marc Heinicke, MD, Department of Visceral and Transplant Surgery, Bern University Hospital
- Principal Investigator: Philipp C Nett, Dr, DRNN, Inselspital, Bern University Hospital, Switzerland
Publications and helpful links
General Publications
- 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.
- 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.
- Hughes CA, Ducker DA. Adaptation of the small intestine--does it occur in man? Scand J Gastroenterol Suppl. 1982;74:149-58.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK248_07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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