Comparing two surgical techniques for rectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.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 Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.