NCT06314646

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 472 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rectal Cancer
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Transanal Transection and Single-Stapled anastomosis (TTSS)	Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS)
PROCEDURE	Double-stapled Total Mesorectal Excision (TME)	Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)

Timeline

• Start date: 2024-03-26
• Primary completion: 2027-05-31
• Completion: 2027-12-31
• First posted: 2024-03-18
• Last updated: 2024-06-27

Locations

1 site across 1 country: Italy