Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-01 @ 6:49 AM
Study NCT ID:
NCT03120104
Status:
UNKNOWN
Last Update Posted:
2017-04-19
First Post:
2017-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-18', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of The Wexner Score', 'timeFrame': 'measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start', 'description': 'for the change of severity of fecal incontinence assessment'}], 'secondaryOutcomes': [{'measure': "Change of St. Mark's Hospital Incontinence Score", 'timeFrame': 'measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start', 'description': 'for the change of severity of fecal incontinence assessment'}, {'measure': 'Change of Functional assessment of Cancer Therapy - Colorectal (FACT-C)', 'timeFrame': 'measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start', 'description': 'for the change of quality of life assessment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Fecal incontinence is common in patients with rectal cancer after surgery. Previous studies showed that pelvic floor muscle and external sphincter muscle training after stoma closure could improve the severity of incontinence and other fecal symptoms, but there is no study about the effects of pelvic floor muscle exercise intervention before stoma closure. We are wondering would the symptom of fecal incontinence recover sooner and better if we give the pelvic floor muscle exercise intervention before the stoma closure. This article aims at comparing the effects of pelvic floor muscle training before stoma closure on fecal incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure (post-intervention group), and we hypothesise that the severity of fecal incontinence will improve sooner and better in pre-intervention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rectal cancer patients who have received transanal total mesorectal excision(TaTME) surgery; 20\\~75 years old\n\nExclusion Criteria:\n\n* terminal stage of cancer; unable to following orders due to poor cognitive condition; too weak to follow the experimental procedures; central nervous system lesions'}, 'identificationModule': {'nctId': 'NCT03120104', 'briefTitle': 'Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision', 'orgStudyIdInfo': {'id': 'N201610007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pre-intervention group', 'description': 'Pre-intervention group interventions:pelvic floor muscle training for one month (2\\~3 times a week, for 4 weeks) just one month before the stoma closure', 'interventionNames': ['Other: pelvic floor muscle exercise before stoma closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Post-intervention group', 'description': 'Post-intervention group: pelvic floor muscle training for one month (2\\~3 times a week, for 4 weeks) two weeks after the stoma closure', 'interventionNames': ['Other: pelvic floor muscle exercise after stoma closure']}], 'interventions': [{'name': 'pelvic floor muscle exercise before stoma closure', 'type': 'OTHER', 'description': 'pelvic floor muscle training for one month (2\\~3 times a week, for 4 weeks) just one month before the stoma closure', 'armGroupLabels': ['Pre-intervention group']}, {'name': 'pelvic floor muscle exercise after stoma closure', 'type': 'OTHER', 'description': 'pelvic floor muscle training for one month (2\\~3 times a week, for 4 weeks) just two weeks after the stoma closure', 'armGroupLabels': ['Post-intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pin Li', 'role': 'CONTACT', 'email': '101476@w.tmu.edu.tw', 'phone': '+886-988-259-482'}, {'name': 'Pin Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University)', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Pin Li', 'role': 'CONTACT', 'email': '101476@w.tmu.edu.tw', 'phone': '+886-988-259-482'}], 'overallOfficials': [{'name': 'Pin Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehabilitation Department of Taipei Municipal WanFang Hospitial (Managed by Taipei Medical University)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}