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NCT Number: NCT06314646

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.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 Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.

Treatment and study plan

Transanal Transection and Single-Stapled anastomosis (TTSS)

Procedure

Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS)

Double-stapled Total Mesorectal Excision (TME)

Procedure

Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)

Primary outcomes

  1. Rate of anastomotic leak

    Time frame: 90 days after surgery

    Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.

Secondary outcomes

  1. Rate of postoperative complications

    Time frame: 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.

  2. Postoperative Recovery Profile (PRP) score

    Time frame: 90 days after surgery

    Median difference of Postoperative Recovery Profile (PRP) [ranging from 0 (completely recovered) to 68 (not recovered)] in the study cohorts.

  3. Proportion of patients fit for stoma closure

    Time frame: 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.

  4. Healthcare costs

    Time frame: 12 months after surgery

    Median difference of healthcare costs (direct and indirect) in the study cohorts.

  5. Low Anterior Resection Syndrome (LARS) score

    Time frame: 6 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.

  6. Low Anterior Resection Syndrome (LARS) score

    Time frame: 12 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.

  7. Low Anterior Resection Syndrome (LARS) score

    Time frame: 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.

  8. Cancer recurrence

    Time frame: 24 months after surgery

    Incidence rate difference of cancer recurrence- defined as any local or distal recurrence or metastasis- in the study cohorts.

Study contacts

Contact information is provided by the study sponsor or research team.

Annalisa Maroli, PhD

CONTACT

[email protected]

02 8224 7776 ext. 0039

Stefano De Zanet, MS

CONTACT

[email protected]

02 8224 4623 ext. 0039

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study 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

Acronym: TTSS-REC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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