Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients (TTSS-REC)

Istituto Clinico Humanitas

Status

Enrolling

Conditions

Surgery

Rectal Cancer

Treatments

Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS)

Procedure: Double-stapled Total Mesorectal Excision (TME)

Study type

Observational

Funder types

Other

Identifiers

NCT06314646

3747

Details and patient eligibility

About

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.

Full description

The Transanal Transection and Single-Stapled anastomosis (TTSS) technique has become a valid alternative to the standard double-stapled anastomosis approach in the surgical treatment of low rectal cancer. Recent evidence showed a significantly reduced number of anastomotic leaks in patients undergoing TTSS compared with patients receiving double-stapled anastomosis, suggesting that TTSS may be technically feasible and may provide a surgical advantage over the traditional double-stapled technique. However, these studies were severely limited by their single-center and retrospective nature. This study aims to confirm the retrospective findings by extending the data collection to additional countries and provide prospective data collection.

Enrollment

472 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.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 Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.