NCT06314646Recruiting
Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients
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
Source: ClinicalTrials.gov · Last updated 27 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 472 (estimated)
- First submitted
- 11 Mar 2024
- Start date
- 26 Mar 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- Istituto Clinico Humanitas
- Diseases
- Colorectal cancer
- NCT number
- NCT06314646
What you commit to
- Study type: Observational
- Planned participants: 472
- From 26 Mar 2024 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring abdominoperineal resection (APR). Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.
Other illness
- 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 Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.
Other
- Immediate or delayed hand-sewn coloanal anastomosis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.