Low Anterior Resection Syndrome Clinical Trial
— PrePostLARSOfficial title:
Quality and Outcomes in Global Cancer Surgery: a Prospective, International Cohort Study Evaluating Low Anterior Resection Syndrome (LARS)
NCT number | NCT04040842 |
Other study ID # | ISUCRS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | December 31, 2023 |
- Aim: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score. - Primary outcome measure: LARS score before surgery and 1 year after the surgery. - Primary comparison: Between average LARS score before and after curative surgery and also comparing these with publish LARS score on normal population.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing rectal cancer surgery on curative intent. - Elective surgery patients. - Laparoscopic, laparoscopic-converted, robotic, TaTME (transanal total mesorectal excision) and open cases will be included. - Patients aged 18 years and over should be included. Exclusion Criteria: - Patients undergoing a procedure purely for diagnosis or staging should be excluded. - Patients with palliative treatment. - Patients with recurrence should be excluded. - Patients with dementia - Patients who do not complete their treatment within 12 months of primary surgery e.g. including reversal of stoma, chemotherapy etc |
Country | Name | City | State |
---|---|---|---|
Lithuania | National Cancer Institute | Vilnius |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute, Lithuania | King's College London, National Cancer Institute (NCI) |
Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LARS score change comparing before surgery and 1 year after the surgery. | Low anterior resection score is a simple questionnaire consisting of five simple questions for bowel function assessment after anterior resection. The maximum number is between 0 and 42. No LARS (good bowel function) is from 0 to 20; minor LARS - 21-29 and major LARS (poor bowel function) more than 29.
Between average LARS score before and after curative surgery and also comparing these with published LARS score on normal population. |
12 months |
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