Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT01337869
Status:
UNKNOWN
Last Update Posted:
2011-04-19
First Post:
2011-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-08-01', 'releaseDate': '2011-07-06'}], 'estimatedResultsFirstSubmitDate': '2011-07-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-18', 'studyFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life and postoperative pain', 'timeFrame': 'within 30 days', 'description': 'Determine patient satisfaction factors using the quality of life survey (SF-36 form) on the 10th-30th day and postoperative pain by using post-operative visual analog pain scale on the 2nd-10th day'}], 'secondaryOutcomes': [{'measure': 'early recurrence rate', 'timeFrame': 'up to 6 months', 'description': 'participants will be followed for the duration of hospital stay and first 30 days, up to 6 months. at the end of the study, recurrence rates will be presented for both groups.'}, {'measure': 'Healing time', 'timeFrame': 'within 30 days', 'description': 'determine wound healing time. the time until complete recovery will be presented.'}, {'measure': 'operative time', 'timeFrame': 'during surgical procedure (day 1)', 'description': 'the time between the beginning of the procedure and last skin suture.'}, {'measure': 'hospital stay', 'timeFrame': 'during first week (one week)', 'description': 'the time to until discharge.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bascom Procedure, Limberg, Pilonidal Disease'], 'conditions': ['Pilonidal Sinus']}, 'referencesModule': {'references': [{'pmid': '12361421', 'type': 'BACKGROUND', 'citation': 'Bascom J, Bascom T. Failed pilonidal surgery: new paradigm and new operation leading to cures. Arch Surg. 2002 Oct;137(10):1146-50; discussion 1151. doi: 10.1001/archsurg.137.10.1146.'}, {'pmid': '17899165', 'type': 'BACKGROUND', 'citation': 'Mentes O, Bagci M, Bilgin T, Ozgul O, Ozdemir M. Limberg flap procedure for pilonidal sinus disease: results of 353 patients. Langenbecks Arch Surg. 2008 Mar;393(2):185-9. doi: 10.1007/s00423-007-0227-9. Epub 2007 Sep 22.'}, {'pmid': '18639221', 'type': 'BACKGROUND', 'citation': "Nordon IM, Senapati A, Cripps NP. A prospective randomized controlled trial of simple Bascom's technique versus Bascom's cleft closure for the treatment of chronic pilonidal disease. Am J Surg. 2009 Feb;197(2):189-92. doi: 10.1016/j.amjsurg.2008.01.020. Epub 2008 Jul 17."}, {'pmid': '19288942', 'type': 'BACKGROUND', 'citation': 'Jamal A, Shamim M, Hashmi F, Qureshi MI. Open excision with secondary healing versus rhomboid excision with Limberg transposition flap in the management of sacrococcygeal pilonidal disease. J Pak Med Assoc. 2009 Mar;59(3):157-60.'}]}, 'descriptionModule': {'briefSummary': 'A pilonidal sinus is a cyst on the natal cleft of the buttocks that often contains hair and skin debris. The condition is common and requires surgery to be cured. Several surgical procedures are described in literature. Limberg Flap technique is frequently used technique for this disease all over the world. However, Bascom Cleft Lift Technique is relatively newer technique. The purpose of this prospective randomized study is comparison of these techniques about patient satisfaction for postoperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All types of pilonidal sinus or cyst\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* acute abscess formation (Cruse-Foord Class IV)\n* patient with minor inflammation are included to trial after two-week antibiotic treatment (Cruse-Foord Class III)'}, 'identificationModule': {'nctId': 'NCT01337869', 'briefTitle': 'Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Trabzon Numune Training and Research Hospital'}, 'officialTitle': 'Comparison of Bascom Cleft Lift Technique Versus Limberg Flap Closure for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Controlled Trial Evaluating for Patient Satisfaction and Early Recurrence', 'orgStudyIdInfo': {'id': 'TNEAH-2010GC1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bascom Cleft Lift Technique', 'interventionNames': ['Procedure: Bascom Cleft Lift']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Limberg Flap Technique', 'interventionNames': ['Procedure: Limberg Flap']}], 'interventions': [{'name': 'Bascom Cleft Lift', 'type': 'PROCEDURE', 'otherNames': ['Bascom Procedure'], 'description': 'Patients are positioned prone. The skin incision is drawn on the natal cleft, marking out the area of skin to be excised. The skin from this side of the natal cleft is then elevated. The skin on the opposite side of the cleft then is undermined to a distance required to allow primary closure of the defect away from the midline without tension. The elevated skin island is excised. The sinuses remaining in the deeper tissues are curetted thoroughly. Hemostasis is maintained. A 12F low-suction drain is sited and fat of the natal cleft then is approximated by using an absorbable suture. The wound is closed with a 3-0 polypropylene suture.The drain remains in situ to time that drainage amount decreases below 20 ml/day. The suture is removed in the clinic 10 day after surgery.', 'armGroupLabels': ['Bascom Cleft Lift Technique']}, {'name': 'Limberg Flap', 'type': 'PROCEDURE', 'otherNames': ['Limbergplasty'], 'description': 'Patients are positioned prone. The area to be excised is mapped-out, and the flap is designed. The area to be excised is mapped on the skin in a rhomboid form. The skin incision is deepened to the presacral fascia. Tissue is removed en bloc. After removing the rhombic excision, the Limberg fascia cutaneous flap is prepared through the right or left-side gluteus maximus fascia. The flap is fully mobilized and transposed medially to fulfill the rhombic defect without any tension. Hemosthasis is accomplished. A 12F low-suction drain is sited and wound is closed in two layers: the subcutaneous tissue with absorbable suture and the skin with 3/0 polypropylene. drain remains in situ to time that drainage amount decreases below 20 ml/day. The suture is removed in the clinic 10 day after surgery.', 'armGroupLabels': ['Limberg Flap Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61040', 'city': 'Trabzon', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ali Guner, M:D:', 'role': 'CONTACT', 'email': 'draliguner@yahoo.com', 'phone': '90-4622302301', 'phoneExt': '1822'}, {'name': 'Ali GUNER, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aydin BOZ, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Can KECE, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erhan REIS, MD,Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Omer F. Ozkan, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Izzettin KAHRAMAN, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Omer Ileli, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Trabzon Numune Training and Research Hospital', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'centralContacts': [{'name': 'Ali GUNER, M.D.', 'role': 'CONTACT', 'email': 'draliguner@yahoo.com'}, {'name': 'Aydin BOZ, M.D.', 'role': 'CONTACT', 'email': 'draydin@msn.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trabzon Numune Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Ali GUNER, M.D.', 'oldOrganization': 'Trabzon Numune Training and Research Hospital, Department of General Surgery'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-07-06', 'type': 'RELEASE'}, {'date': '2011-08-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ali GUNER, MD, MD, Trabzon Numune Training and Research Hospital'}}}}