Clinical trial 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tissue Adhesions
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who will undergo elective abdominal surgery

Brief 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


Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Apeldoorn
country: Netherlands
facility: Gelre Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Harry van Goor, MD, PhD
role: STUDY_DIRECTOR
affiliation: Radboud University Nijmegen Medical Center
name: Richard PG ten Broek
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Dis. 2007 Oct;9 Suppl 2:25-34. doi: 10.1111/j.1463-1318.2007.01358.x.
citation: 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. doi: 10.1148/radiology.217.2.r00oc23421.
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. doi: 10.1007/s00464-005-0092-y. Epub 2005 Oct 24.