Functional Outcome, Quality of Life, Rectal Cancer, Surgery
Conditions
Keywords
Transanal total mesorectal excision, Laparoscopic total mesorectal excision
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.
Interventions
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.
Patients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Switzerland