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

NCT ID: NCT06505863

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-07-01

Brief Summary

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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

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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

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Rectal Cancer Quality of Life Functional Outcome Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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taTME

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

Transanal total mesorectal excision

Intervention Type 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.

abTME

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

Abdominal total mesorectal excision

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hospital of St. Gallen

OTHER

Sponsor Role lead

Responsible Party

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Yanic Ammann

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walter Brunner, PD Dr. med.

Role: STUDY_DIRECTOR

Cantonal Hospital of St. Gallen

Locations

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Cantonal Hospital of St.Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 3184105 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40304801 (View on PubMed)

Other Identifiers

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taTME QoL

Identifier Type: -

Identifier Source: org_study_id

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