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

April 6, 2021 updated by: Quan Wang
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Jilin University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Postoperative patients with middle and low rectal cancer

Description

Inclusion Criteria:

  1. Postoperative patients with middle rectal cancer
  2. Postoperative patients with low rectal cancer

Exclusion Criteria:

(1)Patients refused to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Middle and low rectal cancer
Other: anorectal function test
anorectal function test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: five years after the operation
defined as time from the date of sugery to death
five years after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QLQ-C30
Time Frame: Every three months after the operation
the score of Quality of life questionnaire QLQ-C30
Every three months after the operation
QLQ-CR29
Time Frame: Every three months after the operation
the score of Quality of life questionnaire QLQ-C29
Every three months after the operation
Wexner
Time Frame: Every three months after the operation
the score of questionnaire Wexner
Every three months after the operation
LARS
Time Frame: Every three months after the operation
the score of questionnaire LARS
Every three months after the operation
IIEF-5
Time Frame: Every three months after the operation
the score of questionnaire IIEF-5
Every three months after the operation
CIPE
Time Frame: Every three months after the operation
the score of questionnaire CIPE
Every three months after the operation
FSFI-6
Time Frame: Every three months after the operation
the score of questionnaire FSFI-6
Every three months after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quan Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 26, 2020

Primary Completion (ACTUAL)

February 28, 2021

Study Completion (ACTUAL)

March 28, 2021

Study Registration Dates

First Submitted

January 1, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (ACTUAL)

January 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STARS-RC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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