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

Completed

• Conditions: Rectal Cancer
• Interventions: Other: anorectal function test

• Registration Number: NCT04697303
• Lead Sponsor: Quan Wang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-26
• Study First Submitted: 2021-01-01
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Middle and low rectal cancer	anorectal function test	-

Primary Outcome Measures

Name	Time	Method
Overall survival	five years after the operation	defined as time from the date of sugery to death

Secondary Outcome Measures

Name	Time	Method
LARS	Every three months after the operation	the score of questionnaire LARS
Wexner	Every three months after the operation	the score of questionnaire Wexner
CIPE	Every three months after the operation	the score of questionnaire CIPE
QLQ-CR29	Every three months after the operation	the score of Quality of life questionnaire QLQ-C29
QLQ-C30	Every three months after the operation	the score of Quality of life questionnaire QLQ-C30
IIEF-5	Every three months after the operation	the score of questionnaire IIEF-5
FSFI-6	Every three months after the operation	the score of questionnaire FSFI-6

Trial Locations

Locations (1)

Jilin University First Hospital; 🇨🇳 Changchun, Jilin, China