Morbid ObesityNCT00740662
Intraoperative Measuring of Small Bowel Length Compared to Measuring by Magnetic Resonance Imaging (MRI) in Morbid Obese Patients
An observational study of Morbid Obesity and Weight Loss, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity, Weight Loss
- What is being tested?
- Distal gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbid obese patients scheduled for distal gastric bypass
Who may be able to join
- morbid obese patient
- scheduled for distal gastric bypass
- informed consent for operation and study obtained
Who cannot join
- history of former small bowel resection
- weight > 150 kg
- history of claustrophobia
- general contraindications for MRI (pacer, joint prosthesis, ear implant, etc.)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Visceral and Transplantsurgery, Bern University Hopsital
Bern, 3010
Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital
Bern, 3010
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Morbid Obesity, Weight Loss
- Being tested
- Distal gastric bypass
- Keywords
- morbid obesity, small bowel, gastric bypass, weight loss
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal gastric bypassProcedure or surgery
Distal gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| 1 | Distal gastric bypass Receives: Procedure: Distal gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel length in vivo compared to measurements by MRI
Measured: preoperative, previous to hospital discharge, 6 and 12 months postoperative
Secondary outcomes (2)
Compensatory increase of the common channel (small bowel) after distal bypass
Measured: 12 months postoperative
Correlation of longterm weight regain with increase of common channel length
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Recruiting problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Marc Heinicke, MD, Study director, Department of Visceral and Transplant Surgery, Bern University HospitalPhilipp C Nett, Dr, Principal investigator, DRNN, Inselspital, Bern University Hospital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740662
- Sponsor's protocol ID
- KEK248_07
- Status last verified
- Dec 2012
- First submitted
- 22 Aug 2008
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 6824877Swaniker 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.
PubMed 7472920Hughes CA, Ducker DA. Adaptation of the small intestine--does it occur in man? Scand J Gastroenterol Suppl. 1982;74:149-58.
PubMed 6815778Wyss 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.
PubMed 17021699Patak 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.
PubMed 17566036
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00740662
- Acronym / sponsor ID
- KEK248_07
- Conditions
- Morbid Obesity, Weight Loss
- Keywords
- morbid obesity, small bowel, gastric bypass, weight loss
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruiting problems
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Distal gastric bypassDistal gastric bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbid obese patients scheduled for distal gastric bypass
Key inclusion criteria (3 listed)
- morbid obese patient
- scheduled for distal gastric bypass
- informed consent for operation and study obtained
Key exclusion criteria (4 listed)
- history of former small bowel resection
- weight > 150 kg
- history of claustrophobia
- general contraindications for MRI (pacer, joint prosthesis, ear implant, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal gastric bypassDistal gastric bypass | Procedure or surgery | 1 |
Primary outcome
Small bowel length in vivo compared to measurements by MRI
Time frame: preoperative, previous to hospital discharge, 6 and 12 months postoperative
2 secondary outcomes
Compensatory increase of the common channel (small bowel) after distal bypass
Time frame: 12 months postoperative
Correlation of longterm weight regain with increase of common channel length
Time frame: 12 months postoperative
Results and safety
The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- Background: PubMed 6824877Miskowiak 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.
- Background: PubMed 7472920Swaniker 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.
- Background: PubMed 6815778Hughes CA, Ducker DA. Adaptation of the small intestine--does it occur in man? Scand J Gastroenterol Suppl. 1982;74:149-58.
- Background: PubMed 17021699Wyss 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.
- Background: PubMed 17566036Patak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc Heinicke, MD study director
Department of Visceral and Transplant Surgery, Bern University Hospital
Philipp C Nett, Dr principal investigator
DRNN, Inselspital, Bern University Hospital, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Weight Loss, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small bowel length in vivo compared to measurements by MRI (time frame: preoperative, previous to hospital discharge, 6 and 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740662, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.