Clinical Trials Directory

Trials / Completed

CompletedNCT06505863

Quality of Life After Transanal Total Mesorectal Excision Compared to Traditional Total Mesorectal Excision

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

Status
Completed
Phase
Study type
Observational
Enrollment
249 (actual)
Sponsor
Cantonal Hospital of St. Gallen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETransanal total mesorectal excisionTransanal approach in surgical treatment of rectal cancer along the anatomical and embryological planes, called total mesorectal excision, as described in 1988 by Heald et al.
PROCEDUREAbdominal total mesorectal excisionPatients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III

Timeline

Start date
2024-08-01
Primary completion
2025-01-01
Completion
2025-07-01
First posted
2024-07-17
Last updated
2025-07-14

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT06505863. Inclusion in this directory is not an endorsement.