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

NCT06505863 | Completed

• 1 other identifier: taTME QoL
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

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)

Conditions

Rectal Cancer; Quality of Life; Functional Outcome; Surgery

Keywords

Transanal total mesorectal excision; Laparoscopic total mesorectal excision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional outcomes

  5 years after initial operation

Study Arms (2)

taTME

Patients who underwent transanal total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III

Procedure: Transanal total mesorectal excision

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

Interventions

Transanal total mesorectal excision PROCEDURE

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.

taTME

Abdominal total mesorectal excision PROCEDURE

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

abTME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer

You may not qualify if:

• diagnoses other than rectal cancer
• recurrent rectal cancer
• partial mesorectal excision
• discontinuity resection (no anastomosis)
• incomplete TNM staging information
• metastatic cancer
• day mortality
• lack of quality of life data
• patient decline
• age under 18 years

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Cantonal Hospital of St.Gallen

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 3184105 BACKGROUND

• Ammann Y, Klein M, Marti L, Warschkow R, Strose L, Sparn M, Jager T, Bischofberger S, Brunner W. Does transanal total mesorectal excision (taTME) result in better quality of life and functional outcomes than traditional TME does? A retrospective propensity score-adjusted cohort study. Langenbecks Arch Surg. 2025 Apr 30;410(1):149. doi: 10.1007/s00423-025-03724-6.

  PMID: 40304801 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Walter Brunner, PD Dr. med.

  Cantonal Hospital of St. Gallen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)