Randomised multicentre trial of circular stapling devices.

Area of Science:

• Colorectal surgery
• Surgical devices
• Clinical trials

Background:

• Anastomotic leakage is a significant complication after anterior resection for rectal cancer.
• Previous register data suggested a potential difference in leakage rates between two circular stapling devices.

Purpose of the Study:

• To compare the risk of anastomotic leakage between Ethicon™ PROXIMATE™ ILS™ and Autosuture™ Premium Plus CEEA™ stapling devices.
• To evaluate the safety and efficacy of different surgical stapling devices in rectal cancer surgery.

Main Methods:

• A randomized multicenter study included 529 patients over 18 years old undergoing anterior resection for rectal cancer.
• Patients were randomly assigned to receive either the Ethicon™ PROXIMATE™ ILS™ or Autosuture™ Premium Plus CEEA™ stapling device.
• Anastomotic leakage was defined as a clinically manifest leak.

Main Results:

• A total of 529 patients were randomized, with a 9.4% leak rate for PROXIMATE™ ILS™ and 7.3% for Premium Plus CEEA™.
• The overall leak rate in the study was 8.3%, with no statistically significant difference between the two devices (p=0.419).
• The study was terminated early due to product replacements at several centers.

Conclusions:

• No significant difference in anastomotic leak rates was observed between the two circular stapling devices.
• The findings suggest that surgical devices should demonstrate superiority in randomized trials or be monitored in quality registers before widespread adoption.
• Further large-scale studies are needed to definitively compare the safety and efficacy of different surgical stapling devices.