NCT06314646 Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients
| NCT ID | NCT06314646 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 472 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 472 participants in total. It began in 2024-03-26 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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 Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.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 Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.
Contact & Investigator
Antonino Spinelli, MD, PhD
PRINCIPAL INVESTIGATOR
IRCCS Huamanitas Research Hospital
Frequently Asked Questions
Who can join the NCT06314646 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06314646 currently recruiting?
Yes, NCT06314646 is actively recruiting participants. Contact the research team at colorapp@humanitas.it for enrollment information.
Where is the NCT06314646 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT06314646 clinical trial?
NCT06314646 is sponsored by Istituto Clinico Humanitas. The principal investigator is Antonino Spinelli, MD, PhD at IRCCS Huamanitas Research Hospital. The trial plans to enroll 472 participants.
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