Prospective, Multicenter Randomized Controlled Trial Comparing Two Hemorrhoidopexy Staplers: The HEMOSTASIS Study

Abstract

The objective of this study was to compare two hemorrhoidopexy staplers (EEA versus PPH03). Stapled hemorrhoidopexy is a treatment option for patients with symptomatic internal hemorrhoids who have failed more conservative measures. However, staple line bleeding remains common. Recent improvements in stapler design have attempted to reduce intraoperative bleeding and the need for intervention. HEMOSTASIS is a prospective, multicenter, 1:1 randomized controlled trial. Twelve hospital centers in the United States enrolled participants between 18 and 85 years of age with symptomatic grades 2 to 3 internal hemorrhoids. The primary end point was intraoperative bleeding, defined as bleeding requiring intervention (e.g., placement of sutures, cauterization, or ligation to achieve hemostasis). Secondary end points included staple line location, postoperative pain, quality of life, operative time, length of hospital stay, adverse events, and complication rates. On the primary end point, the rates of intraoperative bleeding requiring intervention were 41.0% (32 of 78) with EEA and 70.4% (50 of 71) with PPH (P < 0.001). Treatment for active bleeding was required in 30.8% versus 57.7% (P < 0.001) in the EEA and PPH arms, respectively. There were no significant differences between groups in postoperative pain. Adverse events and perioperative complication rates were generally mild/moderate and were similar between groups: 74.1% (60 of 81) of patients in the EEA group reported at least one adverse event versus 80.9% (55 of 68) in the PPH group (P = 0.32). Intraoperative bleeding occurred less often after stapled hemorrhoidopexy with the EEA stapler compared with the PPH03 stapler. Intervention to achieve hemostasis was required less often with the EEA stapler.