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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-26

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Cancer Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Transanal Transection and Single-Stapled anastomosis (TTSS)

Intervention Type PROCEDURE

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)

Double-stapled Total Mesorectal Excision (TME)

Intervention Type PROCEDURE

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

Interventions

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Transanal Transection and Single-Stapled anastomosis (TTSS)

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

Intervention Type PROCEDURE

Double-stapled Total Mesorectal Excision (TME)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No