Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-02-20 @ 6:04 PM
Study NCT ID:
NCT00412659
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2006-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-31', 'studyFirstSubmitDate': '2006-12-15', 'studyFirstSubmitQcDate': '2006-12-15', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to complete wound healing', 'timeFrame': 'one year or until reoperation'}], 'secondaryOutcomes': [{'measure': 'health-related quality of life', 'timeFrame': 'one year'}, {'measure': 'time needed returning to normal physical activity after operation', 'timeFrame': 'one year or until reoperation'}, {'measure': 'days spent on sick-leave', 'timeFrame': 'one year or until reoperation'}, {'measure': 'health care costs and total costs', 'timeFrame': 'one year'}, {'measure': 'postoperative wound infection rate', 'timeFrame': 'one year or until reoperation'}, {'measure': 'recurrence rate', 'timeFrame': 'one year or until reoperation'}]}, 'conditionsModule': {'keywords': ['Sinus, Pilonidal', 'Pilonidal sinus', 'Pilonidal cysts', 'Pilonidal disease', 'midline excision', 'Karydakis operation', 'expertise based study', 'surgery', 'therapy'], 'conditions': ['Pilonidal Sinus']}, 'referencesModule': {'references': [{'pmid': '15637373', 'type': 'BACKGROUND', 'citation': 'Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cina CS, Walter SD, Haynes B, Schunemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. doi: 10.1136/bmj.330.7482.88.'}, {'pmid': '12432292', 'type': 'BACKGROUND', 'citation': 'Petersen S, Koch R, Stelzner S, Wendlandt TP, Ludwig K. Primary closure techniques in chronic pilonidal sinus: a survey of the results of different surgical approaches. Dis Colon Rectum. 2002 Nov;45(11):1458-67. doi: 10.1007/s10350-004-6451-2.'}, {'pmid': '4128725', 'type': 'BACKGROUND', 'citation': 'Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available.'}, {'pmid': '15521941', 'type': 'BACKGROUND', 'citation': 'Dalenback J, Magnusson O, Wedel N, Rimback G. Prospective follow-up after ambulatory plain midline excision of pilonidal sinus and primary suture under local anaesthesia--efficient, sufficient, and persistent. Colorectal Dis. 2004 Nov;6(6):488-93. doi: 10.1111/j.1463-1318.2004.00693.x.'}, {'pmid': '35289848', 'type': 'DERIVED', 'citation': 'Hemmingsson O, Binnermark F, Odensten C, Rutegard M, Franklin KA, Haapamaki MM. Excision and suture in the midline versus Karydakis flap surgery for pilonidal sinus: randomized clinical trial. BJS Open. 2022 Mar 8;6(2):zrac007. doi: 10.1093/bjsopen/zrac007.'}]}, 'descriptionModule': {'briefSummary': 'The trial compares excision in the midline at surgery for pilonidal disease versus excision lateral of the midline (Karydakis operation) at surgery for pilonidal disease by randomly allocating patients with pilonidal disease to two groups of surgeons, each group being trained for one of the two methods.', 'detailedDescription': "Excision in the midline and primary suture is a long proven method of treating pilonidal sinus. However it's associated with high incidence of post operative infection and recurrence. On the other hand Karydakis operation (excision lateral of the midline, transposition flap and primary suture) is just a slightly more complicated procedure but has five times less recurrences reported in case series. The purpose of the present study is to compare the surgical results and costs of the two surgical methods utilized. In addition the investigators aim to compare the quality of life at defined time points after surgery. Eligible patients are randomized to two groups of surgeons, well trained in either the midline operation or the Karydakis operation (expertise based design). The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.\n\nComparison: Midline excision andd primary suture compared with the Karydakis operation (excision lateral of the midline and primary suture) for pilonidal disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older.\n* Surgery is considered the best available treatment.\n* The patient understands trial information and is capable of making a decision for informed consent after having received information.\n* The patient wants to undergo surgery for pilonidal sinus and accepts participation in the trial.\n\nExclusion Criteria:\n\n* Patient has had a pilonidal abscess during the last four weeks before the planned day of surgery\n* Patient has had surgery (excision) for pilonidal sinus more than once before.'}, 'identificationModule': {'nctId': 'NCT00412659', 'briefTitle': 'Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus', 'orgStudyIdInfo': {'id': 'PSIN-05-178M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midline excision', 'description': 'Midline excision for pilonidal sinus disease.', 'interventionNames': ['Procedure: Surgery for pilonidal disease, midline excision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Karydakis', 'description': 'Karydakis operation for pilonidal sinus disease.', 'interventionNames': ['Procedure: Surgery for pilonidal disease, Karydakis operation']}], 'interventions': [{'name': 'Surgery for pilonidal disease, midline excision', 'type': 'PROCEDURE', 'description': 'A midline excision is made for the treatment of pilonidal sinus disease.', 'armGroupLabels': ['Midline excision']}, {'name': 'Surgery for pilonidal disease, Karydakis operation', 'type': 'PROCEDURE', 'description': 'A Karydakis operation is done for the treatment of pilonidal sinus disease.', 'armGroupLabels': ['Karydakis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 972 80', 'city': 'Luleå', 'country': 'Sweden', 'facility': 'Sunderby Regional Hospital', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'zip': 'SE 90185', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Christoffer Odensten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'County Council of Norrbotten, Sweden'}, {'name': 'Markku M Haapamaki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}, {'name': 'Peter Naredi, MD, Ph D', 'role': 'STUDY_CHAIR', 'affiliation': 'Umeå University'}, {'name': 'Michael Dahlberg, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'County Council of Norrbotten'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'County Council of Norrbotten, Sweden', 'class': 'OTHER_GOV'}, {'name': 'Norrlandstingens Regionförbund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, MD, PhD', 'investigatorFullName': 'Markku Haapamaki', 'investigatorAffiliation': 'Umeå University'}}}}