- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Bern, Suisse, 3010
- Department of Visceral and Transplantsurgery, Bern University Hopsital
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Bern, Suisse, 3010
- Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
1
Distal gastric bypass
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Distal gastric bypass
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Small bowel length in vivo compared to measurements by MRI
Délai: preoperative, previous to hospital discharge, 6 and 12 months postoperative
|
preoperative, previous to hospital discharge, 6 and 12 months postoperative
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Compensatory increase of the common channel (small bowel) after distal bypass
Délai: 12 months postoperative
|
12 months postoperative
|
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Correlation of longterm weight regain with increase of common channel length
Délai: 12 months postoperative
|
12 months postoperative
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Jean-Marc Heinicke, MD, Department of Visceral and Transplant Surgery, Bern University Hospital
- Chercheur principal: Philipp C Nett, Dr, DRNN, Inselspital, Bern University Hospital, Switzerland
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KEK248_07
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