Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-01 @ 12:44 PM
Study NCT ID:
NCT01206868
Status:
COMPLETED
Last Update Posted:
2010-09-22
First Post:
2010-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Fenestration of the Peritoneum in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008210', 'term': 'Lymphocele'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005276', 'term': 'Fenestration, Labyrinth'}], 'ancestors': [{'id': 'D013506', 'term': 'Otologic Surgical Procedures'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-21', 'studyFirstSubmitDate': '2010-09-21', 'studyFirstSubmitQcDate': '2010-09-21', 'lastUpdatePostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of symptomatic lymphoceles', 'timeFrame': '1 - 3 years', 'description': 'Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage'}], 'secondaryOutcomes': [{'measure': 'Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks', 'timeFrame': '1 -10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['kidney, transplantation, surgery, complications, lymphocele, fluid collections.'], 'conditions': ['Incidence of Symptomatic Lymphocele After Kidney Transplantation', 'Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks']}, 'referencesModule': {'references': [{'pmid': '21597401', 'type': 'DERIVED', 'citation': 'Syversveen T, Midtvedt K, Brabrand K, Oyen O, Foss A, Scholz T. Prophylactic peritoneal fenestration to prevent morbidity after kidney transplantation: a randomized study. Transplantation. 2011 Jul 27;92(2):196-202. doi: 10.1097/TP.0b013e318220f57b.'}]}, 'descriptionModule': {'briefSummary': 'A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation.\n\nAdult (\\>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult recipients of kidney transplants from deceased donors\n\nExclusion Criteria:\n\n* Former extensive abdominal surgery\n* Participation in other studies'}, 'identificationModule': {'nctId': 'NCT01206868', 'acronym': 'PROFFEN', 'briefTitle': 'Prophylactic Fenestration of the Peritoneum in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative Lymphoceles', 'orgStudyIdInfo': {'id': 'S-06342a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fenestration', 'description': 'Fenestration of the peritoneum according to the length of the transplanted kidney', 'interventionNames': ['Procedure: Fenestration']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Standard kidney transplantation', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'Fenestration', 'type': 'PROCEDURE', 'description': 'Fenestration of the peritoneum according to the length of the transplanted kidney', 'armGroupLabels': ['Fenestration']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Standard kidney transplantation', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Tim Scholz MD, PhD. Principal Investigator', 'oldOrganization': 'Section for Transplant Surgery, Oslo University Hospital'}}}}