Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00592020
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2007-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-20', 'studyFirstSubmitDate': '2007-12-31', 'studyFirstSubmitQcDate': '2007-12-31', 'lastUpdatePostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoR (Quality of Recovery) - Score', 'timeFrame': 'preoperative, day 1/3/5/7 postoperative'}], 'secondaryOutcomes': [{'measure': 'Quality of Life by SF (Short Form) 36', 'timeFrame': 'preoperative, day 7, week 4, month 6 postoperative'}, {'measure': 'Operation time', 'timeFrame': 'intraoperative'}, {'measure': 'Warm ischemic time', 'timeFrame': 'intraoperative'}, {'measure': 'Postoperative pain measured by VAS (visual analog scale) and amount of analgesia', 'timeFrame': 'day 1/2/3/4/5/6/7 postoperative'}, {'measure': 'Surgical complications', 'timeFrame': 'day 7, week 4, month 6, month 12 postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['kidney', 'transplantation', 'minimal invasive', 'short transverse', 'hockey stick', 'incision', 'quality of life', 'planned kidney transplantation'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection).\n\nEspecially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic.\n\nThe aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal or over 18 years\n* Sole kidney transplantation\n* Consent form'}, 'identificationModule': {'nctId': 'NCT00592020', 'briefTitle': 'Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': '"Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation', 'orgStudyIdInfo': {'id': '220/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Short Transverse Incision', 'interventionNames': ['Procedure: Short Transverse Incision']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Hockey Stick Incision', 'interventionNames': ['Procedure: Hockey Stick Incision']}], 'interventions': [{'name': 'Short Transverse Incision', 'type': 'PROCEDURE', 'description': 'Short Transverse Incision for kidney transplantation', 'armGroupLabels': ['1']}, {'name': 'Hockey Stick Incision', 'type': 'PROCEDURE', 'description': 'Hockey Stick Incision for kidney transplantation', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'University Hospital Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Uta Herden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Daniel Inderbitzin', 'oldOrganization': 'Clinic of Visceral and Transplant Surgery, University Hospital Inselspital, Bern'}}}}