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

C

Cantonal Hospital of St. Gallen

Status

Completed

Conditions

Quality of Life
Surgery
Functional Outcome
Rectal Cancer

Treatments

Procedure: Transanal total mesorectal excision
Procedure: Abdominal total mesorectal excision

Study type

Observational

Funder types

Other

Identifiers

NCT06505863
taTME QoL

Details and patient eligibility

About

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)

Full 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.

Enrollment

249 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

249 participants in 2 patient groups

taTME
Description:
Patients who underwent transanal total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III
Treatment:
Procedure: Transanal total mesorectal excision
abTME
Description:
Patients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III
Treatment:
Procedure: Abdominal total mesorectal excision

Trial contacts and locations

1

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Central trial contact

Yanic Ammann, Dr. med.; Marie Klein, Dr. med.

Data sourced from clinicaltrials.gov

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