Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT00786461
Status:
UNKNOWN
Last Update Posted:
2008-11-06
First Post:
2008-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-11-05', 'studyFirstSubmitDate': '2008-11-05', 'studyFirstSubmitQcDate': '2008-11-05', 'lastUpdatePostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment', 'timeFrame': 'up to one year after treatment'}], 'secondaryOutcomes': [{'measure': 'Wound healing, local burning, sequelae, hospitalisation time', 'timeFrame': '3-4 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['silver nitrate', 'marsupialisation'], 'conditions': ['Bartholin´s Cyst']}, 'descriptionModule': {'briefSummary': "Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization treatment.\n\nIt is expected that silver nitrate treatment is effective, simple, inexpensive and the least anaesthetic requiring procedure, which can easily be carried out in the outpatient setting.", 'detailedDescription': "Background and objective:\n\nBartholin gland cysts and abscesses are common problems in women of reproductive age. The traditional treatment of Bartholin´s cyst or abscess is marsupialization, which has disadvantages, such as pain of long duration, scarring, risk of general anaesthesia and risk of recurrence. In the present study we use silver nitrate in the treatment of Bartholin's cyst or abscess and compare to marsupialization. We expect lower healing time, lower recurrence rate and less pain with the silver nitrate treatment.\n\nMethods and materials:\n\n30 patients with Bartholin´s cyst or abscess will be investigated. It is prospective randomized study. The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.\n\nThe standard marsupialization treatment is performed under general anaesthesia."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with a age of 18-60 years\n* Should read and understand Danish\n* All women inclusive pregnant should have a Bartholins cyst or abscess\n\nExclusion Criteria:\n\n* Subject who cannot give written informed consent'}, 'identificationModule': {'nctId': 'NCT00786461', 'briefTitle': 'The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate', 'orgStudyIdInfo': {'id': '2005-000494-22'}}, 'armsInterventionsModule': {'interventions': [{'name': 'silver nitrate application to the Bartholin´s cyst', 'type': 'PROCEDURE', 'description': '5 mm in diameter and 5 mm in length crystalloid silver nitrate stick is inserted into the cyst or abscess cavity.'}, {'name': 'silver nitrat stick', 'type': 'PROCEDURE', 'description': 'The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8900', 'city': 'Randers', 'state': 'Randers', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Pinar Bor, MD, PhD', 'role': 'CONTACT', 'email': 'pinarbor@yahoo.com', 'phone': '004589102503'}], 'facility': 'Randers Central Hospital', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}], 'centralContacts': [{'name': 'Pinar Bor, MD, Ph.d', 'role': 'CONTACT', 'email': 'pinarbor@yahoo.com', 'phone': '+45 89102503'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Randers Regional Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Pinar Bor, M.D', 'oldOrganization': 'Randers Hospital'}}}}