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

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)

Study Overview

• Status: Completed
• Conditions: Quality of Life; Rectal Cancer; Surgery; Functional Outcome
• Intervention / Treatment: Procedure: Transanal total mesorectal excision; Procedure: Abdominal total mesorectal excision

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.

• Study Type: Observational
• Enrollment (Actual): 249

Contacts and Locations

Study Locations

• Switzerland
  • Saint-Gall, Switzerland, 9000
    • Cantonal Hospital of St.Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer at the Cantonal hospital of St.Gallen, Switzerland.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
taTME; Patients who underwent transanal total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III	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.
abTME; Patients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QoL)	Assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30): Overall QoL; QLQ-total	5 years after initial operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcomes	Assessed 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	5 years after initial operation

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Study Director: Walter Brunner, PD Dr. med., Cantonal Hospital of St. Gallen

Publications and helpful links

General Publications

• Heald RJ. The 'Holy Plane' of rectal surgery. J R Soc Med. 1988 Sep;81(9):503-8. doi: 10.1177/014107688808100904. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Transanal total mesorectal excision; Laparoscopic total mesorectal excision
• Other Study ID Numbers: taTME QoL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The anonymized patient data that support the findings of this study are available and can be obtained upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No