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

Radboud University Medical Center

Status: Enrolling

Conditions: Tissue Adhesions

Treatments: Other: CineMRI

Study type: Observational

Funder types: Other

Identifiers

NCT00882167

RU-RTB-0001

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

1

Description:

Patients with laparotomy in history

Treatment:

Other: CineMRI