Skip to main content
Clinical Trials/NCT06505863
NCT06505863
Completed
Not Applicable

Does Transanal Total Mesorectal Excision (taTME) Result in Better Quality of Life and Functional Outcomes Than Traditional Total Mesorectal Excision? A Retrospective Propensity Score-adjusted Cohort Study

Cantonal Hospital of St. Gallen1 site in 1 country249 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Cantonal Hospital of St. Gallen
Enrollment
249
Locations
1
Primary Endpoint
Quality of life (QoL)
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

The improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (QoL) and functional outcomes. Evidence for long-term QoL and functional outcomes of transanal total mesorectal excision (taTME) is not provided in current literature. This study will compare short-term and long-term QoL and functional outcomes after taTME compared to traditional abdominal TME (laparoscopic, robotic, and open approach)

Detailed Description

Quality of life and functional outcomes of patients undergoing taTME or abTME for stage I-III rectal cancer will be analysed. A retrospective propensity score-adjusted analysis of prospectively conducted data will be performed. The primary endpoint QoL will be assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30). Secondary endpoints are the functional outcomes according to the EORTC QLQ-C30 questionnaire.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
July 1, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yanic Ammann

Dr. med.

Cantonal Hospital of St. Gallen

Eligibility Criteria

Inclusion Criteria

  • elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer

Exclusion Criteria

  • diagnoses other than rectal cancer
  • recurrent rectal cancer
  • partial mesorectal excision
  • discontinuity resection (no anastomosis)
  • incomplete TNM staging information
  • metastatic cancer
  • 30-day mortality
  • lack of quality of life data
  • patient decline
  • age under 18 years

Outcomes

Primary Outcomes

Quality of life (QoL)

Time Frame: 5 years after initial operation

Assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30): * Overall QoL * QLQ-total

Secondary Outcomes

  • Functional outcomes(5 years after initial operation)

Study Sites (1)

Loading locations...

Similar Trials