Mortality Clinical Trial
Official title:
Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study
This study assessed whether transanal TME in patients with rectal cancer is superior to open, laparoscopic, and robotic TME (abdominal TME (abTME)) regarding oncological outcome, postoperative morbidity and 90-day mortality.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - all patients receiving elective total mesorectal excision Exclusion Criteria: - diagnosis other than rectal cancer - partial mesorectal excision - discontinuity resection (no anastomosis) - incomplete Staging - metastatic cancer - lack of follow-up - decline of a retrospective data Analysis - age under 18 years |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of surgery, Cantonal hospital of St. Gallen | St. Gallen | Saint Gallen |
Lead Sponsor | Collaborator |
---|---|
Cantonal Hospital of St. Gallen |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | time from surgery to end of follow-up or death | 60 months | |
Primary | cancer-specific survival | time from surgery to end of follow-up or death due to rectal cancer | 60 months | |
Primary | disease-specific survival | time from surgery to end of follow-up or death due to or recurrence of rectal cancer | 60 months | |
Secondary | positive resection margin | tumor extending to the resection margin in pathological examination (R0, R1) | 30 days | |
Secondary | Quirke Score | Quality of mesorectal excision in pathological examination (Good, modest, bad) | 30 days | |
Secondary | circular resection margin (CRM) | size of circular resection margin (mm) in pathological examination | 30 days | |
Secondary | number of lymph nodes | number of lymph nodes in pathological examination | 30 days | |
Secondary | postoperative morbidity | Number of patients with postoperative complications (bleeding, anastomotic leakage, ileus, sacral infect, fistula, other surgical complications). The complications will be classified according the Clavien-Dindo-Classification | 30 days | |
Secondary | postoperative 90-day mortality | Number of patients who die in the first 90 days after surgery | 90 days | |
Secondary | relapse-free survival | local recurrence | 60 months | |
Secondary | recurrence-free survival | local or systemic recurrence | 60 months |
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