NCT06314646

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Mar 2024Dec 2027

First Submitted

Initial submission to the registry

March 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

3.2 years

First QC Date

March 11, 2024

Last Update Submit

June 25, 2024

Conditions

Rectal CancerSurgery

Keywords

Rectal CancerTransanal Transection and Single-Stapled anastomosisTotal Mesorectal Excision

Outcome Measures

Primary Outcomes (1)

  • Rate of anastomotic leak

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

    90 days after surgery

Secondary Outcomes (8)

  • Rate of postoperative complications

    90 days after surgery

  • Postoperative Recovery Profile (PRP) score

    90 days after surgery

  • Proportion of patients fit for stoma closure

    12 months after surgery

  • Healthcare costs

    12 months after surgery

  • Low Anterior Resection Syndrome (LARS) score

    6 months after surgery or stoma closure

  • +3 more secondary outcomes

Study Arms (2)

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)

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)

Interventions

Transanal Transection and Single-Stapled anastomosis (TTSS)PROCEDURE

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

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)

Double-stapled Total Mesorectal Excision (TME)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Antonino Spinelli, MD, PhD

    IRCCS Huamanitas Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, PhD

CONTACT

02 8224 7776colorapp@humanitas.it

Stefano De Zanet, MS

CONTACT

02 8224 4623colorapp@humanitas.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

March 26, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)