- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697303
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
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
-
-
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:
- Postoperative patients with middle rectal cancer
- 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
|
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
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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