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NCT Number: NCT00882167

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital, Arnhem, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CineMRI

Other

CineMRI scan of the abdomen at 1.5 Tesla.

Primary outcomes

  1. Sensitivity and specificity

    Time frame: 2 weeks

    diagnsotic accuracy for detecting adhesions

Study contacts

Contact information is provided by the study sponsor or research team.

Richard ten Broek

CONTACT

[email protected]

+31243619493

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2009
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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