Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions
Study Details
Study Description
Brief Summary
Official title:
Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI) detecting intra-abdominal adhesions
Background:
Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of a normal wound healing. However in some patients adhesions cause severe complications such as chronic pain, obstruction and strangulation of the bowel. Adhesions can also obstruct access to the peritoneal cavity and complicate reoperations. Accurate imaging of adhesions would be of benefit avoiding adhesion related complications at repeated laparotomy or laparoscopy. At present no validated diagnostic tool mapping adhesions exists.
Purpose:
To define the sensitivity and specificity of functional cineMRI in detecting and mapping adhesions in patients undergoing reoperation.
Design:
Prospective multicenter observational trial
Primary outcome:
Sensitivity and specificity of functional MRI detecting adhesions to the abdominal wall
Secondary outcome:
Sensitivity and specificity of functional MRI detecting organ-to-organ adhesions.
Estimated enrollment: 100
Estimated study completion date: dec 2019
Estimated primary completion date: dec 2019
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Patients with laparotomy in history |
Other: CineMRI
CineMRI scan of the abdomen at 1.5 Tesla.
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and specificity [2 weeks]
diagnsotic accuracy for detecting adhesions
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with a median abdominal scar due to a previous open abdominal surgical procedures with a length of at least 10 cm and have given written consent.
Exclusion Criteria:
-
Severe claustrophobia.
-
No MRI allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rijnstate Hospital | Arnhem | Gelderland | Netherlands | |
| 2 | Radboud University Nijmegen Medical Center | Nijmegen | Gelderland | Netherlands | |
| 3 | Jeroen Bosch Hospital | 's Hertogenbosch | Netherlands | ||
| 4 | Gelre Hospital | Apeldoorn | Netherlands | ||
| 5 | Catharina Hospital | Eindhoven | Netherlands |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
- Study Director: Harry van Goor, MD, PhD, Radboud University Nijmegen Medical Center
- Principal Investigator: Richard PG ten Broek, Radboud University Nijmegen Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Lienemann A, Sprenger D, Steitz HO, Korell M, Reiser M. Detection and mapping of intraabdominal adhesions by using functional cine MR imaging: preliminary results. Radiology. 2000 Nov;217(2):421-5.
- Mussack T, Fischer T, Ladurner R, Gangkofer A, Bensler S, Hallfeldt KK, Reiser M, Lienemann A. Cine magnetic resonance imaging vs high-resolution ultrasonography for detection of adhesions after laparoscopic and open incisional hernia repair: a matched pair pilot analysis. Surg Endosc. 2005 Dec;19(12):1538-43. Epub 2005 Oct 24.
- van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Dis. 2007 Oct;9 Suppl 2:25-34. Review.
- RU-RTB-0001