Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions

Recruiting

• Conditions: Tissue Adhesions
• Interventions: Other: CineMRI

• Registration Number: NCT00882167
• Lead Sponsor: Radboud University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	CineMRI	Patients with laparotomy in history

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity	2 weeks	diagnsotic accuracy for detecting adhesions

Trial Locations

Locations (5)

Jeroen Bosch Hospital; 🇳🇱 's Hertogenbosch, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands

Gelre Hospital; 🇳🇱 Apeldoorn, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands