Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 11:39 PM
Study NCT ID:
NCT02353156
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2015-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2015-01-28', 'studyFirstSubmitQcDate': '2015-01-28', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': '1 week', 'description': 'visual analog scale after hemorrhoidectomy at 1 week'}], 'secondaryOutcomes': [{'measure': 'wound healing', 'timeFrame': '4 week', 'description': 'wound healing rate at 4 week'}, {'measure': 'convenience', 'timeFrame': '4 week', 'description': 'questionnaire survey for convenience of wound management after hemorrhoidectomy'}, {'measure': 'urinary difficulty', 'timeFrame': '4 week', 'description': 'IPSS, urinary difficulty questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hemorrhoidectomy', 'postoperative pain', 'Sitz bath', 'Electronic bidet'], 'conditions': ['Hemorrhoid']}, 'referencesModule': {'references': [{'pmid': '21218033', 'type': 'BACKGROUND', 'citation': 'Ryoo S, Song YS, Seo MS, Oh HK, Choe EK, Park KJ. Effect of electronic toilet system (bidet) on anorectal pressure in normal healthy volunteers: influence of different types of water stream and temperature. J Korean Med Sci. 2011 Jan;26(1):71-7. doi: 10.3346/jkms.2011.26.1.71. Epub 2010 Dec 22.'}, {'pmid': '39757160', 'type': 'DERIVED', 'citation': 'Kwon YH, Ryoo SB, Oh HK, Lee JB, Jung HJ, Song KH, Heo SC, Shin R, Lee J, Park KJ. Comparison of warm sitz bath and electronic bidet with a lower-force water flow for postoperative management after hemorrhoidectomy (BIDLOW). BMC Surg. 2025 Jan 6;25(1):5. doi: 10.1186/s12893-024-02737-0.'}]}, 'descriptionModule': {'briefSummary': 'The investigator will perform a randomized clinical trials to compare the effect of pain management and wound healing after hemorrhoidectomy between warm sitz bath and electronic bidet.', 'detailedDescription': 'After hemorrhoidectomy, the patients should take warm sitz bath for relieving pain and inducing wound healing. Electronic bidet is a device for cleansing the anus after defecation, and some patients are using the bidet for sitz bath. Thus, the investigator perform this study for comparing the effect of pain and wound management after hemorrhoidectomy between sitz bath and electronic bidet'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* the patients who undergo hemorrhoidectomy\n\nExclusion Criteria:\n\n* previous history of anal surgery\n* Crohn's anal disease\n* perianal complex abscess or fistula\n* uncontrollable medical disease\n* Tb\n* HIV\n* malignancy\n* immunocompromised\n* pregnancy\n* breast feeding\n* NSAID allergy"}, 'identificationModule': {'nctId': 'NCT02353156', 'briefTitle': 'Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Single Blind, Randomized Controlled, Multicenter Study to Evaluate the Efficacy and Convenience of Electronic Bidet With Very Low Force Flow Fountain System for Pain Control and Wound Healing After Operation for Anal Disease, Compared to Conventional Sitz Bath', 'orgStudyIdInfo': {'id': '2014-3144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic bidet', 'description': 'Electronic bidet for 3min at early morning for 4 weeks after hemorrhoidectomy', 'interventionNames': ['Other: Electronic bidet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitz bath', 'description': 'Wamr sitz bath for 3min at early morning for 4 weeks after hemorrhoidectomy', 'interventionNames': ['Other: Sitz bath']}], 'interventions': [{'name': 'Electronic bidet', 'type': 'OTHER', 'description': 'electronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing', 'armGroupLabels': ['Electronic bidet']}, {'name': 'Sitz bath', 'type': 'OTHER', 'description': 'sitz bath after hemorrhoidectomy for relieving pain and inducing wound healing', 'armGroupLabels': ['Sitz bath']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kyu Joo Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daehang Hospital', 'class': 'OTHER'}, {'name': 'Coway Co', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kyu Joo Park', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}