Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-30 @ 2:10 PM
Study NCT ID:
NCT00882167
Status:
RECRUITING
Last Update Posted:
2025-01-15
First Post:
2009-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2009-04-15', 'studyFirstSubmitQcDate': '2009-04-15', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity', 'timeFrame': '2 weeks', 'description': 'diagnsotic accuracy for detecting adhesions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tissue Adhesions']}, 'referencesModule': {'references': [{'pmid': '17824967', 'type': 'BACKGROUND', '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.'}, {'pmid': '11058638', 'type': 'BACKGROUND', '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.'}, {'pmid': '16247569', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Official title:\n\nSensitivity and predictive value of functional cine magnetic resonance imaging (MRI) detecting intra-abdominal adhesions\n\nBackground:\n\nAdhesions 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.\n\nPurpose:\n\nTo define the sensitivity and specificity of functional cineMRI in detecting and mapping adhesions in patients undergoing reoperation.\n\nDesign:\n\nProspective multicenter observational trial\n\nPrimary outcome:\n\nSensitivity and specificity of functional MRI detecting adhesions to the abdominal wall\n\nSecondary outcome:\n\nSensitivity and specificity of functional MRI detecting organ-to-organ adhesions.\n\nEstimated enrollment: 100\n\nEstimated study completion date: dec 2019\n\nEstimated primary completion date: dec 2019'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who will undergo elective abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Severe claustrophobia.\n* No MRI allowed'}, 'identificationModule': {'nctId': 'NCT00882167', 'briefTitle': 'Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions', 'orgStudyIdInfo': {'id': 'RU-RTB-0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with laparotomy in history', 'interventionNames': ['Other: CineMRI']}], 'interventions': [{'name': 'CineMRI', 'type': 'OTHER', 'description': 'CineMRI scan of the abdomen at 1.5 Tesla.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'state': 'Gelderland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'F Joosten, MD, PhD', 'role': 'CONTACT'}, {'name': 'F Joosten', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'R PG ten Broek', 'role': 'CONTACT', 'email': 'r.tenbroek@chir.umcn.nl', 'phone': '+31243619493'}, {'name': 'C Strik', 'role': 'SUB_INVESTIGATOR'}, {'name': 'R ten Broek', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'H van Goor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radboud University Nijmegen Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': "'s-Hertogenbosch", 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'G Jager', 'role': 'CONTACT'}, {'name': 'G Jager', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jeroen Bosch Hospital', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Apeldoorn', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'H Buscher', 'role': 'CONTACT'}, {'name': 'H Buscher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gelre Hospital', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Eindhoven', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'I de Hingh', 'role': 'CONTACT'}, {'name': 'I de Hingh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'centralContacts': [{'name': 'Richard ten Broek', 'role': 'CONTACT', 'email': 'r.tenbroek@chir.umcn.nl', 'phone': '+31243619493'}], 'overallOfficials': [{'name': 'Harry van Goor, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radboud University Nijmegen Medical Center'}, {'name': 'Richard PG ten Broek', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Nijmegen Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}