Rectal CancerNCT04697303
Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer
An observational study of Rectal Cancer, run by Quan Wang at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- anorectal function test
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2020to 28 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Postoperative patients with middle and low rectal cancer
Who may be able to join
- Postoperative patients with middle rectal cancer
- Postoperative patients with low rectal cancer
Who cannot join
- (1)Patients refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- anorectal function test
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anorectal function testOther
anorectal function test
| Study group | Role | What they receive |
|---|---|---|
| Middle and low rectal cancer | Not described Receives: Other: anorectal function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
defined as time from the date of sugery to death
Measured: five years after the operation
Secondary outcomes (7)
QLQ-C30
the score of Quality of life questionnaire QLQ-C30
Measured: Every three months after the operation
QLQ-CR29
the score of Quality of life questionnaire QLQ-C29
Measured: Every three months after the operation
Wexner
the score of questionnaire Wexner
Measured: Every three months after the operation
LARS
the score of questionnaire LARS
Measured: Every three months after the operation
IIEF-5
the score of questionnaire IIEF-5
Measured: Every three months after the operation
CIPE
the score of questionnaire CIPE
Measured: Every three months after the operation
FSFI-6
the score of questionnaire FSFI-6
Measured: Every three months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start26 Oct 2020
- Primary completion28 Feb 2021
- Study completion28 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697303
- Sponsor's protocol ID
- STARS-RC01
- Status last verified
- Apr 2021
- First submitted
- 1 Jan 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT04697303
- Acronym / sponsor ID
- STARS-RC01
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Quan WangUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Mar 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle and low rectal cancer | – | Other: anorectal function test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postoperative patients with middle and low rectal cancer
Key inclusion criteria (2 listed)
- Postoperative patients with middle rectal cancer
- Postoperative patients with low rectal cancer
Key exclusion criteria (1 listed)
- (1)Patients refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anorectal function testanorectal function test | Other | Middle and low rectal cancer |
Primary outcome
Overall survival
Time frame: five years after the operation
defined as time from the date of sugery to death
7 secondary outcomes
QLQ-C30
Time frame: Every three months after the operation
QLQ-CR29
Time frame: Every three months after the operation
Wexner
Time frame: Every three months after the operation
LARS
Time frame: Every three months after the operation
IIEF-5
Time frame: Every three months after the operation
CIPE
Time frame: Every three months after the operation
FSFI-6
Time frame: Every three months after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Quan Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: five years after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.