Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04155905
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2019-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Marsupialization of Anal Fistulotomy Wound Accelerates Healing and Decreases Post Operative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "patients don't know the procedure"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'comparison between two groups of patients with simple anal fistula subjected to different types of treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-11-02', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time in minutes', 'timeFrame': 'intraoperative', 'description': 'the time taken for completion of the procedure from fistulous track identification to the end of fistulotomy or marsupialization'}, {'measure': 'postoperative pain using visual analogue scale', 'timeFrame': '1 week', 'description': 'pain in the postoperative period'}, {'measure': 'postoperative complications measured by clinical examination and anal sphincter manometry', 'timeFrame': '1 year', 'description': 'examination of the patient for fistula recurrence, history, clinical examination and anal sphincter manometry for anal incontinence'}, {'measure': 'wound healing time', 'timeFrame': '1 year', 'description': 'time taken for wound to be completely healed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['simple anal fistula', 'marsupialization'], 'conditions': ['Anal Fistula']}, 'descriptionModule': {'briefSummary': 'comparison between to groups of patients with simple anal fistula one group underwent sistulotomy the other underwent fistulotomy and marsupialization of the wound edges , the investigator tested the incidence of postoperative complications , time of wound healing , operative time', 'detailedDescription': "This randomized controlled trial was carried in the period between May 2018 and April 2019, on 70 patients undergoing fistulotomy for treatment of simple perianal fistula. Patients were randomly allocated into two equal groups each 35 patients, group A; underwent fistulotomy without marsupialization of the edges of fistulotomy wound. And group B; underwent fistulotomy with marsupialization of the wound edges.\n\nPatients included in this study are those suffering simple non recurrent perianal fistula with ASA I and II.\n\nthe investigator excluded patients with secondary anal fistula, complex fistula, anal incontinence, previous anal surgery and any disease or drug that affects wound healing.\n\nAll patients were subjected to thorough history taking and careful anal examination to assess the sphincter integrity, define the fistulous track and internal opening, endo anal ultrasound or magnetic resonance imaging was ordered when needed.\n\nFistulotomy was done under spinal anesthesia in the lithotomy position after skin preparation and patient draping; anal examination under anesthesia was done, identification of the internal opening carried out using palpation and inspection using proctoscope, injection of hydrogen peroxide in the external opening done if internal opening couldn't be defined easily, then the fistulous track was probed, it was laid open using diathermy, in group B the wounds was marsupialized by suturing the skin edges to the edges of the track floor using absorbable sutures (polygalactin) 3\\\\0. Figures (1) and (2) shows the probed fistulous track and its' wound after marsupialization.\n\nPostoperative non adherent dressing impregnated with local anesthetic cream was applied to the wound.\n\nNonsteroidal analgesic injection was given in injection form as per need. Follow up was carried out in outpatient clinic by the study surgeons, patients who agreed for participation in the study was instructed to visit the clinic every week for the first three post-operative months then every month for the next 3 months and lastly two visits after 3 and 6 months, the attending surgeon records follow up data including status of wound healing, anal continence and fistula recurrence.\n\nAn informed written consent was taken from all study participants. Randomization was done using computer program. The study was approved from institutional review board and the ethical committee from our university.\n\nDemographic data, operative data, and postoperative data including pain, post-operative complications and time taken for complete wound healing were collected, properly analyzed using the paired t test and Z test using SPSS program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Simple non recurrent perianal fistula with ASA I and II.\n\nExclusion Criteria:\n\n* secondary anal fistula,\n* complex fistula,\n* anal incontinence,\n* previous anal surgery\n* Any disease or drug that affects wound healing.'}, 'identificationModule': {'nctId': 'NCT04155905', 'briefTitle': 'Marsupialization of Anal Fistulotomy Wound Accelerates Healing and Decreases Post Operative Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Fistulotomy Versus Fistulotomy With Marsupialization of Wound Edges in Simple Perianal Fistula, a Comparative Clinical Trial', 'orgStudyIdInfo': {'id': 'marsupialization anal fistula'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A fistulotomy group', 'description': '35 patients with simple anal fistula subjected to fistulotomy', 'interventionNames': ['Procedure: fistulotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B marsupialization group', 'description': '35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound', 'interventionNames': ['Procedure: fistulotomy and marsupialization of wound edges']}], 'interventions': [{'name': 'fistulotomy and marsupialization of wound edges', 'type': 'PROCEDURE', 'description': 'after defining the fistulous track it was laid open (marsupialization) was done together with marsupialization of the wound edge with vicryl 3\\\\0 sutures', 'armGroupLabels': ['group B marsupialization group']}, {'name': 'fistulotomy', 'type': 'PROCEDURE', 'description': 'after defining the fistulous track it was laid open (marsupialization)', 'armGroupLabels': ['group A fistulotomy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqya', 'country': 'Egypt', 'facility': 'Zagazig Faculty of Medicine', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hazem Nour Abdellatif', 'investigatorAffiliation': 'Zagazig University'}}}}