Transanal total mesorectal excision for rectal cancer has been suspended in Norway
Phase observationalN = 157
- Population
- All patients who underwent TaTME for rectal cancer in Norway between October 2014 and October 2018
- Design
- Non-randomised registry cohort study. Data on all 157 patients who underwent transanal total mesorectal excision (TaTME) for rectal cancer in Norway between October 2014 and October 2018 (three of seven hospitals abandoned TaTME after a total of five procedures) were compared with national cohorts from the Norwegian Colorectal Cancer Registry (local recurrence) and the Norwegian Registry for Gastrointestinal Surgery (anastomotic leak). Kaplan-Meier estimates were used to compare local recurrence.
- Arms
- National registry cohorts (control): Patients in the Norwegian Colorectal Cancer Registry (local recurrence comparison) and the Norwegian Registry for Gastrointestinal Surgery (anastomotic leak comparison); the surgical approach in these cohorts is not specified in the abstract
- TaTME (all Norwegian patients) (experimental, n = 157): Transanal total mesorectal excision
- People
- Wasmuth HH, senior author Rashid G, Norwegian TaTME Collaborative Group, on behalf of the Norwegian Colorectal Cancer Group
Δ 28.8-month Local recurrence after rectal surgery+9.2 pointsΔ Anastomotic leakage+3.9 points
Show the numbers
| Endpoint | Analysis | TaTME (all Norwegian patients) | National registry cohorts | Effect |
|---|---|---|---|---|
| Local recurrence after rectal surgeryAll 157 TaTME patients versus the Norwegian Colorectal Cancer Registry national cohortEstimated (Kaplan-Meier) local recurrence rate at 2.4 years | finalWasmuth 2020 | 11.6% at 28.8 mo (6.6–19.9%) | 2.4% at 28.8 mo (1.4–4.3%) | P<0.001Observed local recurrences: 12 of 157 (7.6%), eight of them multifocal or extensive. Adjusted hazard ratio 6.71 (95% CI 2.94 to 15.32); the abstract does not label its direction, and with higher recurrence after TaTME it can only describe TaTME relative to the national cohort. The abstract's conclusion: local recurrence rates and growth patterns were unfavourable. |
| Anastomotic leakageTaTME cohort versus the Norwegian Registry for Gastrointestinal Surgery national cohortAnastomotic leaks resulting in reoperation | finalWasmuth 2020 | 8.4% | 4.5% | P=0.047Secondary aim. Fifty-six patients (35.7%) had a stoma at latest follow-up; 39 (24.8%) were permanent. |
| Endpoint | Analysis | TaTME (all Norwegian patients) | National registry cohorts | Effect |
|---|---|---|---|---|
| Local recurrence after rectal surgeryAll 157 TaTME patients versus the Norwegian Colorectal Cancer Registry national cohortEstimated (Kaplan-Meier) local recurrence rate at 2.4 years | finalWasmuth 2020 | 11.6% at 28.8 mo (6.6–19.9%) | 2.4% at 28.8 mo (1.4–4.3%) | P<0.001Observed local recurrences: 12 of 157 (7.6%), eight of them multifocal or extensive. Adjusted hazard ratio 6.71 (95% CI 2.94 to 15.32); the abstract does not label its direction, and with higher recurrence after TaTME it can only describe TaTME relative to the national cohort. The abstract's conclusion: local recurrence rates and growth patterns were unfavourable. |
| Anastomotic leakageTaTME cohort versus the Norwegian Registry for Gastrointestinal Surgery national cohortAnastomotic leaks resulting in reoperation | finalWasmuth 2020 | 8.4% | 4.5% | P=0.047Secondary aim. Fifty-six patients (35.7%) had a stoma at latest follow-up; 39 (24.8%) were permanent. |