Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05571202
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2022-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D006484', 'term': 'Hemorrhoids'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine retention rate', 'timeFrame': '0-24 hours post operation.', 'description': 'urine retention events needs foley catheterization'}, {'measure': 'Pain score', 'timeFrame': '0-24 hours post operation.', 'description': 'Visual Analogue Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'surgery complications', 'timeFrame': '0-30 days post operative days.', 'description': 'surgery complications'}, {'measure': 'anesthesia complications', 'timeFrame': '0-30 days post operative days.', 'description': 'anesthesia complications rate'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anorectal surgery, hemorrhoid, anesthesia'], 'conditions': ['Anorectal Disorder']}, 'descriptionModule': {'briefSummary': 'Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. General and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.', 'detailedDescription': "Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Deep level of anesthesia is required for these surgeries. Excellent operation conditions and rapid recovery is anticipated for optimal anesthesia. Various surgical and anesthetic techniques, including spinal anesthesia, general anesthesia and local infiltration have been used to increase the level of patients' perioperative analgesia and decrease the length of stay in the hospital. Among them, general and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.\n\nInclusion Criteria:\n\n* \\>20 years old patients\n* ASA 1-2 patients\n* Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.\n\nExclusion Criteria:\n\n* Having known hypersensitivity to amide type local anesthetics\n* Patients ASA \\>=3\n* Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty\n* Fournier gangrene patients\n* Surgery due to previous complications.\n\nCharacteristic data\n\n1. Age, Gender, ASA class,\n2. Past history: medical history, surgical history\n3. Previous anorectal history\n4. Type of anorectal surgery, number of hemorrhoidectomy\n5. Methods of anesthesia, posture during surgery\n6. Postoperative recovery room record: vital sign, Post Anaesthetic Discharge Scoring System (0-10, \\>9 can discharge)\n7. Ward record: vital sign and urine retention need foley catherization"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Benign anorectal disease patients underwent surgery interventions. Characteristics of age, gender, height, weight, ASA score, past medical history, operational history were recorded from EHIS systems. Intraoperative findings which include anesthesia time, operation time, intraoperative fluid. Surgical outcomes include surgery complications, anesthesia complications, pain score. All of above data were retrospective recorded from hospital discharge note, OPD records, operation note, pathology report.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>20 years old patients\n* ASA 1-2 patients\n* Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.\n\nExclusion Criteria:\n\n* Having known hypersensitivity to amide type local anesthetics\n* Patients ASA \\>=3\n* Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty\n* Fournier gangrene patients\n* Surgery due to previous complications'}, 'identificationModule': {'nctId': 'NCT05571202', 'briefTitle': 'Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Pain Score and Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery, Retrospective Observation Study', 'orgStudyIdInfo': {'id': 'CG22204A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anorectal surgery patient under general anesthesia plus local infiltration', 'description': 'Anorectal surgery patient under general anesthesia plus local infiltration', 'interventionNames': ['Procedure: General anesthesia plus local infiltration']}, {'label': 'Anorectal surgery patient under spinal anesthesia', 'description': 'Anorectal surgery patient under spinal anesthesia alone', 'interventionNames': ['Procedure: Spinal anesthesia']}], 'interventions': [{'name': 'General anesthesia plus local infiltration', 'type': 'PROCEDURE', 'description': 'The eligible patients underwent anorectal surgery under general anesthesia (GE, GM, IVG) plus locally injected analgesics.', 'armGroupLabels': ['Anorectal surgery patient under general anesthesia plus local infiltration']}, {'name': 'Spinal anesthesia', 'type': 'PROCEDURE', 'description': 'The eligible patients underwent anorectal surgery under spinal anesthesia alone.', 'armGroupLabels': ['Anorectal surgery patient under spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Verterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Chun-Yu Lin, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}