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Recruiting NCT06314646

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

— Observational Rectal Cancer Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transanal Transection and Single-Stapled anastomosis (TTSS), Double-stapled Total Mesorectal Excision (TME).
Who it may be relevant to
Registry conditions: Rectal Cancer, Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Rate of anastomotic leak [Time frame: 90 days after surgery]
Secondary outcome measures (8)
  • Rate of postoperative complications [Time frame: 90 days after surgery]
  • Postoperative Recovery Profile (PRP) score [Time frame: 90 days after surgery]
  • Proportion of patients fit for stoma closure [Time frame: 12 months after surgery]
  • Healthcare costs [Time frame: 12 months after surgery]
  • Low Anterior Resection Syndrome (LARS) score [Time frame: 6 months after surgery or stoma closure]
  • Low Anterior Resection Syndrome (LARS) score [Time frame: 12 months after surgery or stoma closure]
  • Low Anterior Resection Syndrome (LARS) score [Time frame: 24 months after surgery or stoma closure]
  • Cancer recurrence [Time frame: 24 months after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Humanitas Research Hospital — Rozzano

Identifiers

NCT: NCT06314646 · 3747

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗