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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00882167
First received: April 15, 2009
Last updated: November 4, 2014
Last verified: November 2014
  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:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Sensitivity and specificity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    diagnsotic accuracy for detecting adhesions


Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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