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

Tissue Adhesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00882167
• Other study ID #: RU-RTB-0001
• Status: Recruiting
• Start date: April 2009
• Est. completion date: December 2020

Study information

• Verified date: November 2016
• Source: Radboud University
• Contact: Richard ten Broek
• Phone: +31243619493
• Email: r.tenbroek[@]chir.umcn.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tissue Adhesions

Intervention

Other:
• CineMRI
CineMRI scan of the abdomen at 1.5 Tesla.

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Hospital	's Hertogenbosch
Netherlands	Gelre Hospital	Apeldoorn
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Lienemann A, Sprenger D, Steitz HO, Korell M, Reiser M. Detection and mapping of intraabdominal adhesions by using functional cine MR imaging: preliminary results. Radiology. 2000 Nov;217(2):421-5. — View Citation

Mussack T, Fischer T, Ladurner R, Gangkofer A, Bensler S, Hallfeldt KK, Reiser M, Lienemann A. Cine magnetic resonance imaging vs high-resolution ultrasonography for detection of adhesions after laparoscopic and open incisional hernia repair: a matched pair pilot analysis. Surg Endosc. 2005 Dec;19(12):1538-43. Epub 2005 Oct 24. — View Citation

van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Dis. 2007 Oct;9 Suppl 2:25-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity	diagnsotic accuracy for detecting adhesions	2 weeks