Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Jeroen Bosch Hospital
NOT_YET_RECRUITING
's-hertogenbosch
Gelre Hospital
NOT_YET_RECRUITING
Apeldoorn
Rijnstate Hospital
NOT_YET_RECRUITING
Arnhem
Catharina Hospital
NOT_YET_RECRUITING
Eindhoven
Radboud University Nijmegen Medical Center
RECRUITING
Nijmegen
Contact Information
Primary
Richard ten Broek
r.tenbroek@chir.umcn.nl
+31243619493
Time Frame
Start Date: 2009-04
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
1
Patients with laparotomy in history
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov