Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-25 @ 9:00 PM
Study NCT ID:
NCT04758195
Status:
UNKNOWN
Last Update Posted:
2023-06-29
First Post:
2021-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094123', 'term': 'Low Anterior Resection Syndrome'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anorectal function impairment', 'timeFrame': 'at the time of 6 months since the start of treatment', 'description': 'Anorectal function will be assessed by anorectal manometry.'}], 'primaryOutcomes': [{'measure': 'Number of participants with major low anterior resection syndrome score (LARS score)', 'timeFrame': 'at the time of 6 months since the start of treatment'}], 'secondaryOutcomes': [{'measure': 'Quality of life impairment assessed by Short Form 36 (SF-36)', 'timeFrame': 'at the time of 6, 12 months since the start of treatment', 'description': 'Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire.'}, {'measure': 'Number of participants with major low anterior resection syndrome score (LARS score)', 'timeFrame': 'at the time of 1, 3, 12 months since the start of treatment'}, {'measure': 'Bowel function impairment', 'timeFrame': 'at the time of 6, 12 months since the start of treatment', 'description': 'Bowel function will be assessed by Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI). Stool frequency will be recorded in the day and night.'}, {'measure': 'Fecal continence impairment', 'timeFrame': 'at the time of 6, 12 months since the start of treatment', 'description': 'Fecal incontinence will be assessed by Wexner incontinence scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Anterior Resection Syndrome', 'Transanal irrigation', 'Rectal cancer', 'Prevention'], 'conditions': ['Low Anterior Resection Syndrome']}, 'descriptionModule': {'briefSummary': 'Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. No consensus exists for LARS treatment or prevention. Transanal irrigation (TAI) was reported to play a helpful role in the management of major LARS and fecal incontinence. However, the preventive effect and daily accessibility need further confirmation. In this randomized trial, TAI compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. The primary outcome is the occurrence of major LARS after 6 months of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-75 years old\n* Curative low anterior resection for rectal cancer with diverting stoma\n* Stoma closure within 1 month\n* Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge\n* No evidence of anastomotic leakage or severe stenosis\n\nExclusion Criteria:\n\n* Tumor recurrence or distant metastasis\n* Secondary operation with stoma\n* Prior disease impairing bowel function except for rectal cancer\n* Any contraindication for transanal irrigation\n* Pregnant or nursing\n* Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease\n* Cognitive or psychological disorder'}, 'identificationModule': {'nctId': 'NCT04758195', 'acronym': 'TAILARS', 'briefTitle': 'Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients', 'orgStudyIdInfo': {'id': 'E2021004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transanal irrigation', 'description': 'Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.', 'interventionNames': ['Procedure: Transanal irrigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best supportive therapy', 'description': 'Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.', 'interventionNames': ['Other: Best supportive therapy']}], 'interventions': [{'name': 'Transanal irrigation', 'type': 'PROCEDURE', 'description': 'Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.', 'armGroupLabels': ['Transanal irrigation']}, {'name': 'Best supportive therapy', 'type': 'OTHER', 'description': 'Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.', 'armGroupLabels': ['Best supportive therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiyuan Qin, M.D.', 'role': 'CONTACT', 'email': 'qinqy3@mail.sysu.edu.cn', 'phone': '86-20-38254052'}], 'facility': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qiyuan Qin, M.D.', 'role': 'CONTACT', 'email': 'qinqy3@mail.sysu.edu.cn', 'phone': '86-20-38254052'}], 'overallOfficials': [{'name': 'Qiyuan Qin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Sixth Affiliated Hospital, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}