Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-30 @ 2:10 PM
Study NCT ID:
NCT00882167
Status:
RECRUITING
Last Update Posted:
2025-01-15
First Post:
2009-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
Official Title:
Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: