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

Sensitivity and Predictive Value of Functional 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

Study Overview

• Status: Unknown
• Conditions: Tissue Adhesions
• Intervention / Treatment: Other: CineMRI

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Richard ten Broek; Phone Number: +31243619493; Email: r.tenbroek@chir.umcn.nl

Study Locations

• Netherlands
  • 's Hertogenbosch, Netherlands
    • Not yet recruiting
    • Jeroen Bosch Hospital
    • Contact: G Jager
    • Principal Investigator: G Jager
  • Apeldoorn, Netherlands
    • Not yet recruiting
    • Gelre Hospital
    • Contact: H Buscher
    • Principal Investigator: H Buscher
  • Eindhoven, Netherlands
    • Not yet recruiting
    • Catharina Hospital
    • Principal Investigator: I de Hingh
  • Gelderland
    • Arnhem, Gelderland, Netherlands
      • Not yet recruiting
      • Rijnstate Hospital
      • Contact: F Joosten, MD, PhD
      • Principal Investigator: F Joosten
    • Nijmegen, Gelderland, Netherlands
      • Recruiting
      • Radboud University Nijmegen Medical Center
      • Contact: R PG ten Broek; Phone Number: +31243619493; Email: r.tenbroek@chir.umcn.nl
      • Sub-Investigator: C Strik
      • Principal Investigator: R ten Broek
      • Principal Investigator: H van Goor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who will undergo elective abdominal surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Patients with laparotomy in history	Other: CineMRI; CineMRI scan of the abdomen at 1.5 Tesla.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity	diagnsotic accuracy for detecting adhesions	2 weeks

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Study Director: Harry van Goor, MD, PhD, Radboud University Nijmegen Medical Center; Principal Investigator: Richard PG ten Broek, Radboud University Nijmegen Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 15, 2009
• First Submitted That Met QC Criteria: April 15, 2009
• First Posted (Estimate): April 16, 2009

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: RU-RTB-0001