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

June 25, 2024 updated by: Istituto Clinico Humanitas

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

472

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • IRCCS Humanitas Research Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonino Spinelli, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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)
Patients will undergo rectal cancer surgery through low rectal resection with double-stapled anastomosis Total Mesorectal Excision (TME)
Procedure: Double-stapled Total Mesorectal Excision (TME)
Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of anastomotic leak
Time Frame: 90 days after surgery
Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.
90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days after surgery
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.
90 days after surgery
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.
12 months after surgery
Healthcare costs
Time Frame: 12 months after surgery
Median difference of healthcare costs (direct and indirect) in the study cohorts.
12 months after surgery
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.
24 months after surgery
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 months after surgery or stoma closure
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.
12 months after surgery or stoma closure
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.
24 months after surgery or stoma closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Antonino Spinelli, MD, PhD, IRCCS Huamanitas Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3747

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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