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OpenTrials
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NCT Number: NCT06505863

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

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)

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Functional Outcome Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Quality of Life Rectal Diseases Rectal Neoplasms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cantonal Hospital of St.Gallen

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Quality of life (QoL)

    Time frame: 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 outcomes

  1. Functional outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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