Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT01146769
Status:
UNKNOWN
Last Update Posted:
2010-06-22
First Post:
2010-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-17', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-06-17', 'lastUpdatePostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Squeeze Pressure', 'timeFrame': '1 week before operation and 3 months after operation'}], 'secondaryOutcomes': [{'measure': 'Functional Outcomes', 'timeFrame': '1 week before operation and 3 months post operation', 'description': 'Bowel frequency, Fecal incontinence score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer of rectum', 'Physiotherapy'], 'conditions': ['Cancer of Rectum']}, 'descriptionModule': {'briefSummary': 'The aim of study is to investigate the difference in Maximum Squeeze Pressure in patients with and without pelvic floor muscle training in low anterior resection in peri-operative period', 'detailedDescription': 'The functional outcome after low anterior resection varies greatly. Proportion of patient suffers from urgency and incontinence. Pelvic muscle disuse with atrophy and fibrosis may be a cause for the poor function. Peri-operative pelvic floor muscle training may preserve pelvic floor muscle bulk and function and thus improve functional outcome after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo low anterior resection of rectum\n* Patient consented for study\n\nExclusion Criteria:\n\n* Patient unable to understand pelvic floor exercise\n* Patient who underwent alternative procedure\n* Patient who suffers anastomotic complications after surgery\n* Patient who ileostomy not closed'}, 'identificationModule': {'nctId': 'NCT01146769', 'briefTitle': 'Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection', 'organization': {'class': 'OTHER', 'fullName': 'Kwong Wah Hospital'}, 'officialTitle': 'Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection', 'orgStudyIdInfo': {'id': 'EMTIMS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic floor exercise', 'interventionNames': ['Other: Pelvic floor exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Pelvic floor exercise', 'type': 'OTHER', 'description': 'Pelvic floor strengthening exercise', 'armGroupLabels': ['Pelvic floor exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Patrick Lau', 'role': 'CONTACT', 'email': 'lauyy01@ha.org.hk'}], 'facility': 'Department of Surgery, Kwong Wah Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Patrick Y LAU, MBBS', 'role': 'CONTACT', 'email': 'lauyy01@ha.org.hk', 'phone': '(852) 3517 7919'}], 'overallOfficials': [{'name': 'Patrick Y LAU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Kwong Wah Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kwong Wah Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'LAU Patrick YY', 'oldOrganization': 'Department of Surgery, Kwong Wah Hospital'}}}}