Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-31 @ 1:14 PM
Study NCT ID:
NCT04290351
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2020-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.
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': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemostasis rate', 'timeFrame': '21 days', 'description': 'At the end of the treatment, the proportion of patients without hemorrhoids bleeding will be calculated.'}, {'measure': 'Hemorrhage stopped on the day of treatment.', 'timeFrame': '21 days', 'description': 'It will be determined that the bleeding stops on the day of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoids, Internal']}, 'referencesModule': {'references': [{'pmid': '26309351', 'type': 'BACKGROUND', 'citation': "Lohsiriwat V. Treatment of hemorrhoids: A coloproctologist's view. World J Gastroenterol. 2015 Aug 21;21(31):9245-52. doi: 10.3748/wjg.v21.i31.9245."}, {'pmid': '27721924', 'type': 'BACKGROUND', 'citation': 'Albuquerque A. Rubber band ligation of hemorrhoids: A guide for complications. World J Gastrointest Surg. 2016 Sep 27;8(9):614-620. doi: 10.4240/wjgs.v8.i9.614.'}, {'pmid': '31141063', 'type': 'BACKGROUND', 'citation': 'Schleinstein HP, Averbach M, Averbach P, Correa PAFP, Popoutchi P, Rossini LGB. ENDOSCOPIC BAND LIGATION FOR THE TREATMENT OF HEMORRHOIDAL DISEASE. Arq Gastroenterol. 2019 May 20;56(1):22-27. doi: 10.1590/S0004-2803.201900000-15.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the researchers planned to compare the treatment results of patients undergoing rubber band ligation in addition to drug therapy in hemorrhagic internal hemorrhoids patients and those treated only with anti-hemorrhoidal drugs.', 'detailedDescription': "Introduction: Band ligation is one of the most frequently used methods in the treatment of hemorrhagic internal hemorrhoidal disease. Also, phlebotonic use and surgical excision options are available as an anti-hemorrhoidal drug in the treatment of the disease. Many studies have shown that these methods are safe to use. Band ligation is used quite often in our clinic. Whether or not band ligation is performed, these patients are prescribed phlebotonics as an anti-hemorrhoidal drug.\n\nPurpose: In this study, investigators aimed to investigate the benefit of adding rubber band ligation to treatment in hemorrhagic internal hemorrhoidal disease treated with the anti hemorrhoidal drug.\n\nMethod: The study was planned prospectively and observationally. Patients are not assigned to groups by the researcher. The researcher cannot interfere with the treatment method given to the patient. The method of treatment is the method approved by the patient's doctor.\n\nPatients diagnosed with internal hemorrhoids will be examined in a group of patients who are prescribed anti-hemorrhoidal drugs and rubber band ligation in the context of routine treatment.\n\nIn the other group, again, in the form of routine treatment, patients who are not given rubber band ligation and who are given only anti-hemorrhoidal drugs will be examined.\n\nGroup 1: Patients who have been prescribed 450 mg diosmin + 50 mg hesperidin as an anti-hemorrhoidal drug and rubber band ligation will be included in this group.\n\nGroup 2: Patients who have been prescribed only 450 mg of diosmin + 50 mg of hesperidin as treatment, without rubber band ligation will be included in this group.\n\nPatients will undergo a control examination in the 21 days after treatment.\n\n* Whether the bleeding continues?\n* Which bleeding day stopped?\n* The comfort of the anal area will be evaluated\n* Did the side effect develop?\n* Did any complications occur? The above information will be entered into the SPSS program, and statistical analysis will be done."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 18 and 65 who apply to our hospital from Konya and neighboring provinces and accept the treatments offered, constitute the study population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with internal hemorrhoids with an anamnesis + examination + rectoscope.\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients over 65 years old\n* Pregnant\n* Chronic liver patients\n* Those with bleeding disorders\n* Patients taking anti-coagulants and anti-aggregates\n* Patients with colorectal cancer.\n* Those who have had hemorrhoid surgery before'}, 'identificationModule': {'nctId': 'NCT04290351', 'briefTitle': 'The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.', 'organization': {'class': 'OTHER', 'fullName': 'Konya Meram State Hospital'}, 'officialTitle': 'Comparative Study of Band Ligation and Phlebotonic Drug Versus Only Phlebotonic Drug, in Bleeding Internal Hemorrhoids.', 'orgStudyIdInfo': {'id': 'hemorrhoids X. study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Band ligation and phlebotonic group', 'description': 'Patients with rubber band ligation and the prescribed anti hemorrhoidal drug will be examined in this group.\n\n(Note: The researcher has no contribution or intervention to the treatment method.)', 'interventionNames': ['Procedure: band ligation', 'Drug: oral 450 mg diosmin+50 mg hesperidin']}, {'label': 'Only phlebotonic group', 'description': 'Patients who are prescribed the only 450mg of diosmin + 50mg of hesperidin as a treatment for bleeding internal hemorrhoids will be examined in this group.\n\n(Note: The researcher has no contribution or intervention to the treatment method.)', 'interventionNames': ['Drug: oral 450 mg diosmin+50 mg hesperidin']}], 'interventions': [{'name': 'band ligation', 'type': 'PROCEDURE', 'description': 'Rubber band ligation will be applied to patients, and then phlebotonic will be prescribed.\n\n(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)', 'armGroupLabels': ['Band ligation and phlebotonic group']}, {'name': 'oral 450 mg diosmin+50 mg hesperidin', 'type': 'DRUG', 'description': '450 mg diosmin + 50 mg hesperidin will be prescribed to patients undergoing band ligation.\n\n(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)', 'armGroupLabels': ['Band ligation and phlebotonic group', 'Only phlebotonic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42090', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Konya Training and Research Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Meram State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigators', 'investigatorFullName': 'Alpaslan Şahin', 'investigatorAffiliation': 'Konya Meram State Hospital'}}}}