Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT04697303
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2021-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2021-01-01', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'five years after the operation', 'description': 'defined as time from the date of sugery to death'}], 'secondaryOutcomes': [{'measure': 'QLQ-C30', 'timeFrame': 'Every three months after the operation', 'description': 'the score of Quality of life questionnaire QLQ-C30'}, {'measure': 'QLQ-CR29', 'timeFrame': 'Every three months after the operation', 'description': 'the score of Quality of life questionnaire QLQ-C29'}, {'measure': 'Wexner', 'timeFrame': 'Every three months after the operation', 'description': 'the score of questionnaire Wexner'}, {'measure': 'LARS', 'timeFrame': 'Every three months after the operation', 'description': 'the score of questionnaire LARS'}, {'measure': 'IIEF-5', 'timeFrame': 'Every three months after the operation', 'description': 'the score of questionnaire IIEF-5'}, {'measure': 'CIPE', 'timeFrame': 'Every three months after the operation', 'description': 'the score of questionnaire CIPE'}, {'measure': 'FSFI-6', 'timeFrame': 'Every three months after the operation', 'description': 'the score of questionnaire FSFI-6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Understanding the quality of life and anorectal function changes in patients with middle and low rectal cancer after surgery can guide patients to recover after surgery and provide a valuable reference for surgeons in the selection of surgical methods. The purpose of this study is to: (1) Investigate the complication rate, recurrence and metastasis rate and survival of patients with middle and low rectal cancer. (2) QLQ-C30 and QLQ-CR29 questionnaires were used to assess the quality of life of patients with low- and middle-level rectal cancer at different periods after surgery. (3) Wexner constipation score and LARS syndrome score for anorectal function after operation for low rectal cancer. (4) The CIPE ejaculatory function score, IIEF-5 International Erectile Function Score, and FSFI-6 Female Sexual Function Index were used to assess the changes in sexual function of patients with low- and middle-position rectal cancer after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Postoperative patients with middle and low rectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Postoperative patients with middle rectal cancer\n2. Postoperative patients with low rectal cancer\n\nExclusion Criteria:\n\n(1)Patients refused to participate'}, 'identificationModule': {'nctId': 'NCT04697303', 'briefTitle': 'Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer', 'orgStudyIdInfo': {'id': 'STARS-RC01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Middle and low rectal cancer', 'interventionNames': ['Other: anorectal function test']}], 'interventions': [{'name': 'anorectal function test', 'type': 'OTHER', 'description': 'anorectal function test', 'armGroupLabels': ['Middle and low rectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Jilin University First Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quan Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Quan Wang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}