Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-29 @ 10:35 PM
Study NCT ID:
NCT06794151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-27
First Post:
2025-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study
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': 548}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-21', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy Rate', 'timeFrame': '6 months', 'description': 'The primary endpoint of this study is to evaluate the therapeutic effect of hemorrhoids in patients through physical examinations, digital rectal examinations and other means by doctors who are unaware of the clinical data information six months after the operation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoid']}, 'descriptionModule': {'briefSummary': "This study adopted a multicenter, non-randomized controlled clinical research design. Patients with internal hemorrhoids who met the inclusion criteria were assigned to the endoscopic rubber band ligation group (observation group) or the Milligan-Morgan hemorrhoidectomy group (control group) according to their treatment preferences. Doctors who were unaware of the clinical data information evaluated the patients' postoperative recovery, the occurrence of complications, and the long-term follow-up of treatment efficacy through outpatient reexaminations, WeChat video calls, or telephone calls.\n\nResearch Subjects and Inclusion/Exclusion Criteria 1.1 Research Subjects Patients with grade II-III internal hemorrhoids 1.2 Inclusion Criteria\n\n1. Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification;\n2. Aged between 18 and 80 years old, both males and females;\n3. Those who did not respond well to conservative treatments such as dietary adjustments and medications;\n4. Patients who signed the informed consent form and were willing to cooperate with this study.\n\n1.3 Exclusion Criteria\n\n1. Patients with contraindications to colonoscopy;\n2. Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery;\n3. Pregnant patients;\n4. Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies;\n5. Patients with severe heart, liver, or kidney diseases and coagulation disorders;\n6. Patients with diabetes mellitus and poor blood glucose control;\n7. Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders;\n8. Patients who refused to participate in the study. 1.4 Observation Indicators Primary Indicator: Efficacy Rate Secondary Indicators: Pain, a feeling of fullness and discomfort in the anus, urinary retention, defecation status, long-term therapeutic effect, treatment cost, etc."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with grade II-III internal hemorrhoids', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification; (2) Aged between 18 and 80 years old, both males and females; (3) Those who did not respond well to conservative treatments such as dietary adjustments and medications; (4) Patients who signed the informed consent form and were willing to cooperate with this study.\n\nExclusion Criteria:\n\n* (1) Patients with contraindications to colonoscopy; (2) Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery; (3) Pregnant patients; (4) Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies; (5) Patients with severe heart, liver, or kidney diseases and coagulation disorders; (6) Patients with diabetes mellitus and poor blood glucose control; (7) Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders; (8) Patients who refused to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06794151', 'briefTitle': 'Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study', 'orgStudyIdInfo': {'id': '20241226'}}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'China', 'state': 'Chongqin', 'country': 'China', 'facility': 'Daping Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weidong Tong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: A Multicenter, Non-randomized Controlled Study', 'investigatorFullName': 'Weidong Tong', 'investigatorAffiliation': 'Third Military Medical University'}}}}