Comparing two surgical techniques for rectal cancer treatment
Postoperative and Long-term Outcomes of Transanal Tran-section and Single-stapled Anastomosis (TTSS) in Rectal Can-cer Patients: a Multicentric International IDEAL Stage 2b Prospective Parallel Cohort Study
This study is testing a new surgical technique for rectal cancer to see if it can lead to fewer complications compared to the traditional method for patients having surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 472 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, MI) |
| Trial ID | NCT06314646 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Transanal Transection and Single-Stapled anastomosis (TTSS) technique as an alternative to the traditional double-stapled anastomosis in patients undergoing surgery for low rectal cancer. It aims to compare postoperative and functional outcomes between these two surgical approaches. By expanding data collection to multiple countries, the study seeks to provide robust prospective data to confirm previous findings that suggested TTSS may reduce anastomotic leaks. The research involves adult patients scheduled for elective rectal resection with Total Mesorectal Excision (TME).
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with rectal cancer who are scheduled for elective rectal resection with either TTSS or double-stapled techniques.
Not a fit: Patients requiring abdominoperineal resection or those with concurrent invasive pelvic malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for rectal cancer patients.
How similar studies have performed: Previous studies have suggested the TTSS technique may be advantageous, but this study aims to provide more comprehensive prospective data to validate those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥ 18 years old) patients, men and women, diagnosed with rectal cancer scheduled for elective rectal resection with Total Mesorectal Excision (TME) with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS) approaches. * Patients scheduled for open, laparoscopic, or robotic surgery. * Patients preoperatively indicated for sphincter-saving procedures with or without protective-stoma. Exclusion Criteria: * Immediate or delayed hand-sewn coloanal anastomosis. * Patients requiring abdominoperineal resection (APR). Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study. * Patients with concurrent or previous invasive pelvic malignant tumors. Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.
Where this trial is running
Rozzano, MI
- IRCCS Humanitas Research Hospital — Rozzano, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Antonino Spinelli, MD, PhD — IRCCS Huamanitas Research Hospital
- Study coordinator: Annalisa Maroli, PhD
- Email: colorapp@humanitas.it
- Phone: 02 8224 7776
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.