Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions
Recruitment status was Recruiting
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| First Received Date ICMJE | April 15, 2009 | ||||||||
| Last Updated Date | November 4, 2010 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00882167 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions | ||||||||
| Official Title ICMJE | Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions | ||||||||
| 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 Start study: april 2009 Estimated study completion date: dec 2010 Estimated primary completion date: jun 2010 |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patient who will undergo elective abdominal surgery |
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| Condition ICMJE | Tissue Adhesions | ||||||||
| Intervention ICMJE | Other: CineMRI
CineMRI scan of the abdomen at 1.5 Tesla. |
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| Study Group/Cohort (s) | 1
Patients with laparotomy in history
Intervention: Other: CineMRI |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00882167 | ||||||||
| Other Study ID Numbers ICMJE | RU-RTB-0001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | H. van Goor, Radboud University Nijmegen Medical Center | ||||||||
| Study Sponsor ICMJE | Radboud University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||||||
| Verification Date | October 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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