Rectal CancerNCT05445245
The Longitudinal Study of Low Anterior Resection Syndrome in Patients with Newly Diagnosed Rectal Cancer.
An observational study of Rectal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aims are to identify the trajectory of LAR Syndrome and explore the adaptation process and coping strategies of LAR Syndrome in patients newly diagnosed with rectal cancer. The participants will recruit from a CRC surgical outpatient department of a medical center in northern Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Apr 2022to 24 Jan 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rectal cancer patients during therapy.
Who may be able to join
- Patients with stage I to III rectal cancer.
- Patients already know their condition.
- 4. Aged 20 years and older. 5. Consciously communicate in Mandarin or Taiwanese. 6. Agreed with the interview and had signed the permit.
Who cannot join
- Patients with Stage IV rectal cancer.
- Recurred rectal cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Longitudinal Study of Low Anterior Resection Syndrome, Psychological Distress, and Fecal Incontinence-related Quality of Life in Patients with Newly Diagnosed Rectal Cancer.
The aims are to identify the trajectory of LAR Syndrome and explore the adaptation process and coping strategies of LAR Syndrome in patients newly diagnosed with rectal cancer. The participants will recruit from a CRC surgical outpatient department of a medical center in northern Taiwan.
- Conditions
- Rectal Cancer
- Keywords
- low anterior resection syndrome, psychological distress, quality of life, rectal cancer
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report Questionnaire
show the specific trajectory of LAR Syndrome, psychological distress, and fecal incontinence-related QoL based on different tumor locations in patients with rectal cancer
Measured: Change from baseline symptom at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start14 Apr 2022
- Primary completion31 Dec 2024
- Study completion24 Jan 2025
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.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445245
- Sponsor's protocol ID
- 202101979B0
- Status last verified
- Feb 2024
- First submitted
- 30 Jun 2022
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Longitudinal Study of Low Anterior Resection Syndrome, Psychological Distress, and Fecal Incontinence-related Quality of Life in Patients with Newly Diagnosed Rectal Cancer.
- ClinicalTrials.gov ID
- NCT05445245
- Acronym / sponsor ID
- 202101979B0
- Conditions
- Rectal Cancer
- Keywords
- low anterior resection syndrome, psychological distress, quality of life, rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 6 Jul 2022 (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.
The aims are to identify the trajectory of LAR Syndrome and explore the adaptation process and coping strategies of LAR Syndrome in patients newly diagnosed with rectal cancer. The participants will recruit from a CRC surgical outpatient department of a medical center in northern Taiwan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients during therapy.
Key inclusion criteria (3 listed)
- Patients with stage I to III rectal cancer.
- Patients already know their condition.
- 4. Aged 20 years and older. 5. Consciously communicate in Mandarin or Taiwanese. 6. Agreed with the interview and had signed the permit.
Key exclusion criteria (2 listed)
- Patients with Stage IV rectal cancer.
- Recurred rectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-report Questionnaire
Time frame: Change from baseline symptom at 12 months
show the specific trajectory of LAR Syndrome, psychological distress, and fecal incontinence-related QoL based on different tumor locations in patients with rectal cancer
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 14 Feb 2025.
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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 Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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 14 Feb 2025. 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 Taiwan. 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?
Self-report Questionnaire (time frame: Change from baseline symptom at 12 months). 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 14 Feb 2025.