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

Recruiting

• Conditions: Surgery; Rectal Cancer
• Interventions: Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS); Procedure: Double-stapled Total Mesorectal Excision (TME)

• Registration Number: NCT06314646
• Lead Sponsor: Istituto Clinico Humanitas

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.

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.

Study Timeline

• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-18
• Study Start: 2024-03-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2027-05-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 472

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 Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transanal Transection and Single-Stapled anastomosis (TTSS)	Transanal Transection and Single-Stapled anastomosis (TTSS)	Patients will undergo rectal cancer surgery through low rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS)
Double-stapled Total Mesorectal Excision (TME)	Double-stapled Total Mesorectal Excision (TME)	Patients will undergo rectal cancer surgery through low rectal resection with double-stapled anastomosis Total Mesorectal Excision (TME)

Primary Outcome Measures

Name	Time	Method
Rate of anastomotic leak	90 days after surgery	Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients fit for stoma closure	12 months after surgery	Proportion difference of patients fit for stoma closure in the study cohorts. Patients fit for stoma closure have already closed the stoma or have an intact anastomosis as demonstrated by a water contrast enema, Computed Tomography (CT) scan, endoscopic, or surgical revision.
Postoperative Recovery Profile (PRP) score	90 days after surgery	Median difference of Postoperative Recovery Profile (PRP) \[ranging from 0 (completely recovered) to 68 (not recovered)\] in the study cohorts.
Low Anterior Resection Syndrome (LARS) score	24 months after surgery or stoma closure	Median difference of Low Anterior Resection Syndrome (LARS) score \[ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)\] in the study cohorts.
Cancer recurrence	24 months after surgery	Incidence rate difference of cancer recurrence- defined as any local or distal recurrence or metastasis- in the study cohorts.
Rate of postoperative complications	90 days after surgery	Rate difference of overall postoperative complications- classified according to the Clavien-Dindo scale \[ranging from 0 (no complications) to 5 (complications leading to death)\]- in the study cohorts.
Healthcare costs	12 months after surgery	Median difference of healthcare costs (direct and indirect) in the study cohorts.

Trial Locations

Locations (1)

IRCCS Humanitas Research Hospital; 🇮🇹 Rozzano, MI, Italy