Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT05429060
Status:
UNKNOWN
Last Update Posted:
2022-06-23
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-17', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-06-17', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Short Health Scale-HD score at 1 year after hemorrhoidal surgery', 'timeFrame': '1 year', 'description': 'Changes in quality of life from baseline at 1 year in terms of Short Health Scale (SHS) specific to hemorrhoidal disease (HD) will be reported for each surgical treatment. The SHS-HD scores will be recorded preoperatively, at 1 week, 6 weeks, and 12 months.'}, {'measure': 'Hemorrhoidal Disease Symptom Score at 1 year after hemorrhoidal surgery', 'timeFrame': '1 year', 'description': 'Changes in symptoms from baseline at 1 year will be reported for each surgical treatment. Hemorrhoidal Disease Symptom Score (HDSS) described by Nyström based on 5 cardinal symptoms (pain, itching, bleeding, soiling, and prolapse) will be recorded preoperatively, at 1 week, 6 weeks, and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '1 year', 'description': 'Determining recurrence rate at 1 year for each treatment. Relapse of patient-reported symptoms (pain, itching, bleeding, soiling, and prolapse) will be recorded at 1 year.'}, {'measure': 'Complications', 'timeFrame': '1 year', 'description': 'Determining early and late complications for each treatment. Early complications (abscess, urinary retention) will be assessed at 6 weeks. Late complications (incontinence, anal stenosis) will be assessed at 12 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoids', 'Quality of Life', 'Complication of Treatment', 'Indication, Unlabeled']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of surgical treatments on the quality of life in hemorrhoidal disease. All available treatment methods will be included in this 1-year cohort which is going to collect data from a big metropol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults who underwent any interventional treatment other than medical therapy under local and/or general anesthesia will be eligible.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical interventions under local and/or general anesthesia\n* Elective or emergency interventions (including thrombectomy)\n* Surgical interventions in operation room or office\n* Any kind of excision, sclerotherapy, ligation, suturation, ablation, mucopexy\n\nExclusion Criteria:\n\n* Any accompanying perianal disease (anal fistula, anal fissure, perianal abscess, anal condyloma extending into the anal canal)\n* Previous surgery for hemorrhoids (any intervention other than medical treatment)\n* Previous perianal surgery (internal sphincterotomy, fistula surgery)\n* Pelvic and/or perineal radiotherapy\n* Previous obstetric or perianal injury and/or sphincter repair\n* Previous rectal surgery (distal colectomy for benign or malignant etiology)'}, 'identificationModule': {'nctId': 'NCT05429060', 'briefTitle': 'A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'A Prospective Assessment of Surgical Treatments in Hemorrhoidal Disease: Real-life Practice and Early Outcome in Terms of Patient-reported Symptoms and Quality of Life', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-109'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hemorrhoidal surgery', 'type': 'PROCEDURE', 'description': 'All surgical interventions under general or local anesthesia, either in the office or operation room, including any type of injection, excision, ligation, ablation, mucopexy and suturation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34196', 'city': 'Istanbul', 'state': 'Bahcelievler', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Osman Civil, MD', 'role': 'CONTACT', 'email': 'dr.ocivil@hotmail.com', 'phone': '+905058334286'}, {'name': 'Nevin Sakoglu, MD', 'role': 'CONTACT', 'email': 'nsakoglu@medipol.edu.tr', 'phone': '+905333741297'}, {'name': 'Nuri Okkabaz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Naciye Cigdem Arslan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medipol University Bahcelievler Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Naciye Cigdem Arslan, MD', 'role': 'CONTACT', 'email': 'cigdemarslan@hotmail.it', 'phone': '+905313890975'}], 'overallOfficials': [{'name': 'Naciye Cigdem Arslan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}