- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05445245
The Longitudinal Study of Low Anterior Resection Syndrome in Patients with Newly Diagnosed Rectal Cancer.
February 12, 2025 updated by: Chang Gung Memorial Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
125
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
-
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Kwei-Shan Dist.
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Taoyuan City, Kwei-Shan Dist., Taiwan, 333
- Chung Gung University
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Rectal cancer patients during therapy.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with Stage IV rectal cancer.
- Recurred rectal cancer.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from baseline symptom at 12 months
|
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)
April 14, 2022
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
January 24, 2025
Study Registration Dates
First Submitted
June 30, 2022
First Submitted That Met QC Criteria
June 30, 2022
First Posted (Actual)
July 6, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 12, 2025
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Postoperative Complications
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Low Anterior Resection Syndrome
- Rectal Neoplasms
Other Study ID Numbers
- 202101979B0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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