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

Surgery Clinical Trial

— TTSS-REC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314646
• Other study ID #: 3747
• Status: Not yet recruiting
• Start date: May 31, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Istituto Clinico Humanitas
• Contact: Annalisa Maroli, PhD
• Phone: 02 8224 7776
• Email: colorapp[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 472
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Surgery

Intervention

Procedure:
• Transanal Transection and Single-Stapled anastomosis (TTSS)
Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS)
• Double-stapled Total Mesorectal Excision (TME)
Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of anastomotic leak	Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.	90 days after surgery
Secondary	Rate of postoperative complications	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.	90 days after surgery
Secondary	Postoperative Recovery Profile (PRP) score	Median difference of Postoperative Recovery Profile (PRP) [ranging from 0 (completely recovered) to 68 (not recovered)] in the study cohorts.	90 days after surgery
Secondary	Proportion of patients fit for stoma closure	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.	12 months after surgery
Secondary	Healthcare costs	Median difference of healthcare costs (direct and indirect) in the study cohorts.	12 months after surgery
Secondary	Low Anterior Resection Syndrome (LARS) score	Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.	6 months after surgery or stoma closure
Secondary	Low Anterior Resection Syndrome (LARS) score	Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.	12 months after surgery or stoma closure
Secondary	Low Anterior Resection Syndrome (LARS) score	Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.	24 months after surgery or stoma closure
Secondary	Cancer recurrence	Incidence rate difference of cancer recurrence- defined as any local or distal recurrence or metastasis- in the study cohorts.	24 months after surgery