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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transanal total mesorectal excision | Transanal 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. |
| PROCEDURE | Abdominal total mesorectal excision | Patients 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.