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

NCT04697303 | Completed

• 1 other identifier: STARS-RC01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  defined as time from the date of sugery to death

  five years after the operation

Secondary Outcomes (7)

• QLQ-C30

  Every three months after the operation

• QLQ-CR29

  Every three months after the operation

• Wexner

  Every three months after the operation

• LARS

  Every three months after the operation

• IIEF-5

  Every three months after the operation

Study Arms (1)

Middle and low rectal cancer

Other: anorectal function test

Interventions

anorectal function test OTHER

anorectal function test

Middle and low rectal cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postoperative patients with middle and low rectal cancer

You may qualify if:

• Postoperative patients with middle rectal cancer
• Postoperative patients with low rectal cancer

You may not qualify if:

• (1)Patients refused to participate

Sponsors & Collaborators

• Quan Wang: lead

Study Sites (1)

Jilin University First Hospital

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 6, 2021
• Study Start: October 26, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 28, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)