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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with laparotomy in history |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CineMRI | Other | CineMRI scan of the abdomen at 1.5 Tesla. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity | diagnsotic accuracy for detecting adhesions | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patient who will undergo elective abdominal surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard ten Broek | Contact | +31243619493 | r.tenbroek@chir.umcn.nl |
| Name | Affiliation | Role |
|---|---|---|
| Harry van Goor, MD, PhD | Radboud University Nijmegen Medical Center | Study Director |
| Richard PG ten Broek | Radboud University Nijmegen Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Not yet recruiting | Arnhem | Gelderland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17824967 | Background | 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. | |
| 11058638 | 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. |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Radboud University Nijmegen Medical Center | Recruiting | Nijmegen | Gelderland | Netherlands |
|
| Jeroen Bosch Hospital | Not yet recruiting | 's-Hertogenbosch | Netherlands |
|
| Gelre Hospital | Not yet recruiting | Apeldoorn | Netherlands |
|
| Catharina Hospital | Not yet recruiting | Eindhoven | Netherlands |
|
| 16247569 | 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. |