Evaluating patient outcomes after rectal cancer surgery
Patient Reported Outcomes Following Cancer of the Rectum
This study is trying to see how different surgical methods for rectal cancer affect patients' recovery, quality of life, and bowel function after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital Gregorio Marañón Academic / other |
| Locations | 2 sites (Madrid and 1 other locations) |
| Trial ID | NCT04936581 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who have undergone Total Mesorectal Excision (TME) for rectal cancer, assessing the impact of different surgical approaches on patient-reported outcomes. It aims to evaluate the prevalence of low anterior resection syndrome (LARS) and its effects on quality of life, bowel function, and other related complications. The study will collect data from 90 participants over a two-year period, utilizing validated questionnaires to measure various aspects of recovery and functionality post-surgery.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 diagnosed with rectal cancer located below the peritoneal reflection who are undergoing TME surgery.
Not a fit: Patients with upper rectal cancer, stage IV disease, or those who have had previous pelvic radiotherapy or radical prostatectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for rectal cancer patients, enhancing their quality of life post-surgery.
How similar studies have performed: Other studies have shown success in evaluating patient-reported outcomes following rectal cancer surgeries, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years old * Informed consent * Diagnosed with rectal cancer located below the peritoneal reflection, defined by preoperative MRI * Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches * Patients with/without derivative stoma * Patients with/without neoadjuvant treatment Exclusion Criteria: * Upper rectal cancer, located above the peritoneal reflection * Previous radical prostatectomy * Previous pelvic radiotherapy * Rectal resection without primary anastomosis * Intraoperative findings of peritoneal carcinomatosis * Stage IV disease * Multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder * Rectal resection due to a benign condition * Rectal resection due to a recurrence of rectal cancer (previous anterior resection or another primary neoplasm) * Rectal resection following a 'watch \& wait' program * Emergency surgery * Previous derivative colostomy * Inflammatory bowel disease
Where this trial is running
Madrid and 1 other locations
- University Clinic of Navarre — Madrid, Spain (Recruiting)
- University Hospital Gregorio Marañón — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Patricia Tejedor
- Email: patricia.tejedor@hotmail.com
- Phone: +34 91 586 7007
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.