Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT05038605
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2021-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical vs Oral Metronidazole After Benign Anorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}, {'id': 'D005401', 'term': 'Fissure in Ano'}, {'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2021-08-29', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain score', 'timeFrame': 'at one day after surgery', 'description': 'Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain'}, {'measure': 'Postoperative pain score', 'timeFrame': 'at two days after surgery', 'description': 'Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain'}, {'measure': 'Postoperative pain score', 'timeFrame': 'at seven days after surgery', 'description': 'Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoids', 'Anal Fissure', 'Anal Fistula']}, 'descriptionModule': {'briefSummary': 'While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. On the other hand, topical application of metronidazole had more consistent favorable results as Ala et al documented a remarkable analgesic effect of topical metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and Armestrong who also concluded similar results.\n\nNo previous study compared the analgesic effect of topical and oral metronidazole after anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral versus systemic metronidazole on pain and recovery after surgery for benign anorectal conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients of either sex aged below 70 years\n* Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula.\n\nExclusion Criteria:\n\n* Grade I-II hemorrhoids.\n* acute anal fissure.\n* complex anal fistula\n* perianal abscess\n* perianal Crohn's disease\n* malignancy."}, 'identificationModule': {'nctId': 'NCT05038605', 'briefTitle': 'Topical vs Oral Metronidazole After Benign Anorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Mansoura2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical metronidazole', 'description': 'Topical application of metronidazole cream on the anal verge after surgery', 'interventionNames': ['Drug: Topical metronidazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral metronidazole', 'description': 'oral metronidazole 500 mg tablets after surgery', 'interventionNames': ['Drug: oral metronidazole']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No metronidazole was received'}], 'interventions': [{'name': 'Topical metronidazole', 'type': 'DRUG', 'description': 'Topical application of metronidazole cream on the anal verge every 8 hours after surgery', 'armGroupLabels': ['Topical metronidazole']}, {'name': 'oral metronidazole', 'type': 'DRUG', 'description': 'Patients received oral metronidazole 500 mg tablets every 8 hours after surgery', 'armGroupLabels': ['Oral metronidazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura university hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of surgery', 'investigatorFullName': 'Sameh Emile', 'investigatorAffiliation': 'Mansoura University'}}}}