Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT01279551
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2011-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009824', 'term': 'Ointments'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2011-01-18', 'studyFirstSubmitQcDate': '2011-01-18', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain related to upper anal canal pressure increasing (yes or no)', 'timeFrame': 'from the intervention to 1 month', 'description': 'To evaluate if the pain post stapled haemorrhoidopexy is related to an increased anal resting pressure or not. The presence of anorectal spasm was assessed by clinical examination and anorectal manometry'}, {'measure': 'Postoperative pain remission', 'timeFrame': 'from 1 to 90 days after intervention', 'description': 'To assess postoperative pain remission'}, {'measure': 'Postoperative anal resting pressure at pain remission', 'timeFrame': 'from 1 to 90 days after intervention', 'description': 'We evaluate with anorectal manometry the anal resting pressure at the time of pain remission'}], 'secondaryOutcomes': [{'measure': 'Duration of therapy', 'timeFrame': 'from 1 to 90 days after intervention', 'description': 'To evaluate how many days of therapy are needed to obtain pain remission'}, {'measure': 'Use of additional analgesic', 'timeFrame': 'from 1 to 90 days to intervention', 'description': 'To evaluate the use of additional drugs respect to standard therapy'}, {'measure': 'Postoperative pain intensity', 'timeFrame': 'from 1 to 90 days after intervention', 'description': 'To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale)'}, {'measure': 'Patients satisfaction', 'timeFrame': '45 days after intervention', 'description': 'To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)'}]}, 'conditionsModule': {'conditions': ['Pain After Stapled Haemorrhoidopexy']}, 'referencesModule': {'references': [{'pmid': '23652752', 'type': 'DERIVED', 'citation': "Mari FS, Nigri G, Dall'Oglio A, Cosenza UM, Milillo A, Terrenato I, Pancaldi A, Brescia A. Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: a randomized controlled trial. Dis Colon Rectum. 2013 Jun;56(6):768-73. doi: 10.1097/DCR.0b013e31828b282c."}]}, 'descriptionModule': {'briefSummary': 'This study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the postoperative pain related to anorectal spasm (anismus) while performing a stapled haemorrhoidopexy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse\n* Adults aged ≤ 75, male or female\n\nExclusion Criteria:\n\n* Concomitant ano-rectal disease (fissure, fistula, abscess, inflammatory bowel disease, rectal cancer)'}, 'identificationModule': {'nctId': 'NCT01279551', 'acronym': 'TAGASH', 'briefTitle': 'Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy', 'orgStudyIdInfo': {'id': 'DS-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GTN', 'description': 'In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg', 'interventionNames': ['Drug: 0.4% nitroglycerin ointment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg.', 'interventionNames': ['Drug: lidocaine cloridrato 2.5% ointment']}], 'interventions': [{'name': '0.4% nitroglycerin ointment', 'type': 'DRUG', 'otherNames': ['Rectogesic'], 'description': 'Local endoanal application 2 times a day', 'armGroupLabels': ['GTN']}, {'name': 'lidocaine cloridrato 2.5% ointment', 'type': 'DRUG', 'otherNames': ['Luan'], 'description': 'Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00189', 'city': 'Rome', 'country': 'Italy', 'facility': 'Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Francesco Saverio Mari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome'}, {'name': 'Luigi Masoni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}}}}