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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06505863
Enrollment
249
Registered
2024-07-17
Start date
2024-08-01
Completion date
2025-07-01
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Outcome, Quality of Life, Rectal Cancer, Surgery

Keywords

Transanal total mesorectal excision, Laparoscopic total mesorectal excision

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.

Interventions

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.

PROCEDUREAbdominal total mesorectal excision

Patients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III

Sponsors

Cantonal Hospital of St. Gallen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life (QoL)5 years after initial operationAssessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30): * Overall QoL * QLQ-total

Secondary

MeasureTime frameDescription
Functional outcomes5 years after initial operationAssessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30): * physical functioning * role functioning * cognitive functioning * emotional functioning * social functioning * fatigue * pain * nausea and vomiting * appetite loss * dyspnea * insomnia * constipation * diarrhea * financial difficulties

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026