Short- and Long-term Outcomes of 3-Row Vs 2-Row Circular Staplers for Low Colorectal Anastomosis After Total Mesorectal Excision: A Single-Center, Randomized, Single-Blind, Phase III Trial (THREESTAPLER Study).
Inna Tulina, Petr B Tsugulya, Valeriia Kim et al.
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In 30 seconds
This single-center, randomized, noninferiority trial compared 3-row and 2-row circular staplers for low colorectal anastomosis in 154 patients. The anastomotic leakage rate was 16.9% in the 3-row group versus 15.6% in the 2-row group (p = 0.8), indicating no significant difference in efficacy between the two stapler types.
Key findings
- Anastomotic leakage rates were 16.9% for 3-row vs 15.6% for 2-row staplers (p = 0.8).
- The observed difference in leakage rates was 1.3%, with a 1-sided 95% CI lower bound of -8.47%.
- 5-year overall survival was 80.2% in the 3-row group compared to 83.8% in the 2-row group (p = 0.80).
- Anastomotic stricture rates were 1.4% in the 2-row group and 0.7% in the 3-row group (p = 1).
Why it matters
Understanding the comparative effectiveness of different stapler designs is crucial for minimizing complications such as anastomotic leakage, which can significantly impact patient outcomes and healthcare costs in colorectal surgery.
What to keep in mind
The study was underpowered due to an optimistic sample size estimation, and routine postoperative proctography was not performed, potentially missing clinically silent leaks.