- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Bern, Svizzera, 3010
- Department of Visceral and Transplantsurgery, Bern University Hopsital
-
Bern, Svizzera, 3010
- Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
1
Distal gastric bypass
|
Distal gastric bypass
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Small bowel length in vivo compared to measurements by MRI
Lasso di tempo: preoperative, previous to hospital discharge, 6 and 12 months postoperative
|
preoperative, previous to hospital discharge, 6 and 12 months postoperative
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Compensatory increase of the common channel (small bowel) after distal bypass
Lasso di tempo: 12 months postoperative
|
12 months postoperative
|
|
Correlation of longterm weight regain with increase of common channel length
Lasso di tempo: 12 months postoperative
|
12 months postoperative
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Jean-Marc Heinicke, MD, Department of Visceral and Transplant Surgery, Bern University Hospital
- Investigatore principale: Philipp C Nett, Dr, DRNN, Inselspital, Bern University Hospital, Switzerland
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KEK248_07
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Distal gastric bypass
-
Cairo UniversityReclutamento
-
Ain Shams UniversityCompletatoChirurgia di bypass gastrico | Livelli plasmatici degli ormoni incretiniciEgitto
-
Hanife KöksalUskudar UniversityCompletatoObesità | Disturbi del gusto | Disturbo dell'olfattoTurchia (Türkiye)
-
University Research Institute for the Study of...National and Kapodistrian University of AthensReclutamento
-
Istanbul UniversityCompletatoFrattura dello scafoideTacchino
-
Wonkwang University HospitalCompletatoGastroparesi | Svuotamento gastrico | Cura preoperatoriaCorea del Sud
-
Universitaire Ziekenhuizen KU LeuvenTerminato
-
University of SevilleFundación Progreso y Salud, Consejeria de Salud y Familias, Junta de Andalucía...Completato
-
Puerta de Hierro University HospitalAttivo, non reclutanteComplicanze postoperatorie | Perdita di peso | Obesità patologicaSpagna