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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00882167
First received: April 15, 2009
Last updated: November 4, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Start study: april 2009

Estimated study completion date: dec 2010

Estimated primary completion date: jun 2010


Condition Intervention
Tissue Adhesions
 Other: CineMRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions

Resource links provided by NLM:

MedlinePlus related topics: Adhesions MRI Scans
U.S. FDA Resources

Further study details as provided by Radboud University:

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with laparotomy in history
 Other: CineMRI
CineMRI scan of the abdomen at 1.5 Tesla.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient who will undergo elective abdominal surgery

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882167

Contacts
Contact: Richard ten Broek +31243619493 r.tenbroek@chir.umcn.nl

Locations
Netherlands
Rijnstate Hospital Not yet recruiting
Arnhem, Gelderland, Netherlands
Contact: F Joosten, MD, PhD            
Principal Investigator: F Joosten            
Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Gelderland, Netherlands
Contact: R PG ten Broek     +31243619493     r.tenbroek@chir.umcn.nl    
Sub-Investigator: C Strik            
Principal Investigator: R ten Broek            
Principal Investigator: H van Goor            
Jeroen Bosch Hospital Not yet recruiting
's Hertogenbosch, Netherlands
Contact: G Jager            
Principal Investigator: G Jager            
Gelre Hospital Not yet recruiting
Apeldoorn, Netherlands
Contact: H Buscher            
Principal Investigator: H Buscher            
Catharina Hospital Not yet recruiting
Eindhoven, Netherlands
Contact: I de Hingh            
Principal Investigator: I de Hingh            
Sponsors and Collaborators
Radboud University
Investigators
Study Director: Harry van Goor, MD, PhD Radboud University Nijmegen Medical Center
Principal Investigator: Richard PG ten Broek Radboud University Nijmegen Medical Center
  More Information

Publications:

Responsible Party: H. van Goor, Radboud University Nijmegen Medical Center
ClinicalTrials.gov Identifier: NCT00882167     History of Changes
Other Study ID Numbers: RU-RTB-0001
Study First Received: April 15, 2009
Last Updated: November 4, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013