Clinical trial NCT06314646: Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Surgery
Keywords: Rectal Cancer
Transanal Transection and Single-Stapled anastomosis
Total Mesorectal Excision
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult patients diagnosed with rectal cancer scheduled for elective rectal resection with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS).

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.

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.

Primary outcomes:
measure: Rate of anastomotic leak
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Rate of postoperative complications
timeFrame: 90 days after surgery
measure: Postoperative Recovery Profile (PRP) score
timeFrame: 90 days after surgery
measure: Proportion of patients fit for stoma closure
timeFrame: 12 months after surgery
measure: Healthcare costs
timeFrame: 12 months after surgery
measure: Low Anterior Resection Syndrome (LARS) score
timeFrame: 6 months after surgery or stoma closure
measure: Low Anterior Resection Syndrome (LARS) score
timeFrame: 12 months after surgery or stoma closure
measure: Low Anterior Resection Syndrome (LARS) score
timeFrame: 24 months after surgery or stoma closure
measure: Cancer recurrence
timeFrame: 24 months after surgery
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: MI
Study officials:
affiliation: IRCCS Huamanitas Research Hospital
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: