Evaluating bowel function after rectal cancer surgery
Quality and Outcomes in Global Cancer Surgery: a Prospective, International Cohort Study Evaluating Low Anterior Resection Syndrome (LARS)
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos · NCT04040842
This study is trying to see how bowel function changes in people who have surgery for rectal cancer by asking them questions before and a year after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vilnius) |
| Trial ID | NCT04040842 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess bowel function in patients undergoing curative rectal cancer surgery by using the Low Anterior Resection Score (LARS). Participants will complete a questionnaire evaluating their bowel function before surgery and again one year post-surgery. The study will include various surgical approaches such as laparoscopic and robotic techniques. Patient characteristics, including age and cancer stage, will also be collected to analyze outcomes effectively.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who are undergoing elective surgery for rectal cancer with curative intent.
Not a fit: Patients undergoing palliative treatment, those with recurrent cancer, or individuals with dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into bowel function recovery after rectal cancer surgery, helping to improve patient care and management.
How similar studies have performed: Other studies have successfully evaluated bowel function post-surgery, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vilnius
- National Cancer Institute — Vilnius, Lithuania (RECRUITING)
Study contacts
- Study coordinator: Audrius Dulskas, MD, PhD
- Email: audrius.dulskas@gmail.com
- Phone: 867520094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Low Anterior Resection Syndrome, Rectal cancer, low anterior resection, low anterior resection syndrome