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

NCT00882167 | Recruiting

• 1 other identifier: RU-RTB-0001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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

Conditions

Tissue Adhesions

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity

  diagnsotic accuracy for detecting adhesions

  2 weeks

Study Arms (1)

1

Patients with laparotomy in history

Other: CineMRI

Interventions

CineMRI OTHER

CineMRI scan of the abdomen at 1.5 Tesla.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who will undergo elective abdominal surgery

You may qualify if:

• 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.

You may not qualify if:

• Severe claustrophobia.
• No MRI allowed

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (5)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

NOT YET RECRUITING

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

RECRUITING

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

NOT YET RECRUITING

Gelre Hospital

Apeldoorn, Netherlands

NOT YET RECRUITING

Catharina Hospital

Eindhoven, Netherlands

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 17824967 BACKGROUND

• 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.

  PMID: 11058638 BACKGROUND

• 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.

  PMID: 16247569 BACKGROUND

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry van Goor, MD, PhD

  Radboud University Nijmegen Medical Center

  STUDY DIRECTOR

• Richard PG ten Broek

  Radboud University Nijmegen Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard ten Broek

CONTACT

+31243619493; r.tenbroek@chir.umcn.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-12

Locations

NL (5)