Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03400020
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2018-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2018-01-09', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early postpolypectomy bleeding', 'timeFrame': 'up to 24 hours', 'description': 'bleeding occurring either during an endoscopic procedure or immediately after as hematochezia within 24 hours following the polypectomy procedure.'}, {'measure': 'Late postpolypectomy bleeding', 'timeFrame': 'between day 2 and day 30', 'description': 'bleeding occurring between day 2 and day 30 following the polypectomy procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpolypectomy Bleeding']}, 'descriptionModule': {'briefSummary': 'Postpolypectomy bleeding is the most common major complication following a colonoscopic polypectomy procedure. The incidence rate ranging from 0.3 to 6.1%. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. It has been demonstrated that administration of ascorbic acid (vitamin C) in abdominal surgeries could reduce the blood loss during the procedure, operation time and days of hospitalization. So the investigators designed a prospective, randomized study to compares the efficacy of vitamin C administration with application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps.', 'detailedDescription': 'In this prospective, randomized clinical trial, patients diagnosed with colon polyps with a diameter \\> 10 mm will randomized to receive either a 500 mg vitamin C in normal saline injection or a normal saline injection 2 hours before polypectomy. This administration will continued for 3 days after polypectomoy. Postpolypectomy bleeding is defined either as (1) early: occurring either during an endoscopic procedure or immediately after as hematochezia within 24 h or (2) delayed: any bleeding event that occurring between day 2 and day 30 following the polypectomy procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colorectal polyps larger than 10 mm.\n\nExclusion Criteria:\n\nbleeding tendency poor preparation'}, 'identificationModule': {'nctId': 'NCT03400020', 'briefTitle': 'Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding', 'nctIdAliases': ['NCT03374410'], 'organization': {'class': 'OTHER', 'fullName': 'Ilam University of Medical Sciences'}, 'officialTitle': 'Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding', 'orgStudyIdInfo': {'id': '13961019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ascorbic acid', 'description': 'Ascorbic acid 1000 mg in normal saline IV 2 hours before the operation and thereafter 500 mg in normal saline IV daily for three days.', 'interventionNames': ['Other: Ascorbic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Normal saline IV infusion 2 hours before the operation and for three days after operation.', 'interventionNames': ['Other: Normal Saline']}], 'interventions': [{'name': 'Ascorbic acid', 'type': 'OTHER', 'otherNames': ['Vitamin C'], 'description': 'Ascorbic acid 500 Mg in normal saline IV two hours before the operation and thereafter 500 mg in normal saline IV daily for three days.', 'armGroupLabels': ['Ascorbic acid']}, {'name': 'Normal Saline', 'type': 'OTHER', 'description': 'Normal saline IV two hours before the operation and thereafter for three days.', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Īlām', 'country': 'Iran', 'facility': 'Mostafa Khomaini Hospital', 'geoPoint': {'lat': 33.6374, 'lon': 46.4227}}], 'overallOfficials': [{'name': 'Shaahin Shahbazi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ilam University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ilam University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zahra Vahdat Shariatpanahi', 'investigatorAffiliation': 'Ilam University of Medical Sciences'}}}}