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

Active, not recruiting

• Conditions: Functional Outcome; Quality of Life; Rectal Cancer; Surgery
• Interventions: Procedure: Transanal total mesorectal excision

• Registration Number: NCT06505863
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Study Start: 2024-08-01
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
taTME	Transanal total mesorectal excision	Patients who underwent transanal total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III

Primary Outcome Measures

Name	Time	Method
Quality of life (QoL)	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 Outcome Measures

Name	Time	Method
Functional outcomes	5 years after initial operation	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

Trial Locations

Locations (1)

Cantonal Hospital of St.Gallen; 🇨🇭 Saint-Gall, Switzerland