Mid-term absorbable monofilament is safe and effective for gastrointestinal anastomosis – PROMEGAT - A single-arm prospective observational study

Abstract

Introduction: Various suture materials and suture techniques are used to perform gastrointestinal anastomosis after tumour resection, but the best combination is still a matter of debate. Methods: This multi-centre, international, single-arm, prospective observational study aimed at demonstrating the non-inferiority of a mid-term absorbable monofilament in comparison to braided sutures in gastrointestinal anastomosis. Monosyn suture was used to create the gastrointestinal anastomosis and the frequency of anastomotic leakage until day of discharge was chosen as the primary parameter. The outcome was compared to the results published for braided sutures in the literature. Secondary parameters were the time to perform the anastomosis, length of hospital stay, costs, and postoperative complications. Results: The anastomosis leakage rate was 2.91%, indicating that Monosyn suture was not inferior to braided sutures used in gastrointestinal anastomosis. Of the reported anastomotic suture techniques, the single layer continuous method was the fastest and most economical technique in the present observational study. Conclusion: Monosyn suture is safe and effective in gastrointestinal anastomosis and represents a good alternative to other sutures used for gastrointestinal anastomosis. With regard to safety, time and cost-efficiency, the single-layer continuous technique should be considered a preferred method. The transfer of results from clinical studies into daily practice with regard to surgical techniques for gastrointestinal anastomosis should be further evaluated in larger studies or in nationwide registries. © 2018 The Authors