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NCT04697303 Clinical Trial

Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04697303
Other study ID # STARS-RC01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 26, 2020
Est. completion date March 28, 2021

Study information
Verified date April 2021
Source The First Hospital of Jilin University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date March 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Postoperative patients with middle rectal cancer 2. Postoperative patients with low rectal cancer Exclusion Criteria: (1)Patients refused to participate

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• anorectal function test
anorectal function test

Locations
Country Name City State
China Jilin University First Hospital Changchun Jilin

Sponsors (1)
Lead Sponsor Collaborator
Quan Wang

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival defined as time from the date of sugery to death five years after the operation
Secondary QLQ-C30 the score of Quality of life questionnaire QLQ-C30 Every three months after the operation
Secondary QLQ-CR29 the score of Quality of life questionnaire QLQ-C29 Every three months after the operation
Secondary Wexner the score of questionnaire Wexner Every three months after the operation
Secondary LARS the score of questionnaire LARS Every three months after the operation
Secondary IIEF-5 the score of questionnaire IIEF-5 Every three months after the operation
Secondary CIPE the score of questionnaire CIPE Every three months after the operation
Secondary FSFI-6 the score of questionnaire FSFI-6 Every three months after the operation
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