PPH-01 Versus PPH-03 to Perform STARR for the Treatment of Hemorrhoids Associated With Large Internal Rectal Prolapse

Purpose. This multicenter randomized study was designed to compare the clinical and functional results of stapled transanal rectal resection (STARR) performed with 2 staplers (PPH-01 vs. PPH-03) in the treatment of hemorrhoidal disease associated with a large internal rectal prolapse. Methods. From a total of 937 patients, referred for hemorrhoidal disease in the 20 centers involved in the study, 425 (45.3%) with prolapsed hemorrhoids associated with a large internal rectal prolapse were randomized to undergo STARR with PPH-01 or PPH-03. Postoperative evaluation was made at 3, 6, and 12 months. Results. The incidence of bleeding at the stapled line was significantly lower in the PPH-03 group than in the PPH-01 group (58/207 [28.0%] vs. 145/201 [72.1%]; P < .0001); the mean number of hemostatic stitches was significantly higher in the PPH-01 than in the PPH-03 group (3.2 ± 0.1 vs. 1.8 ± 0.8; P < .0001). The mean operative time was 25.1 ± 11.5 minutes in the PPH-03 group and 38.1 ± 15.7 minutes in the PPH-01 group (P < .0001). No major complications occurred in either of the groups. At 12-month follow-up, the success rate in the 2 groups was 94.5% in the PPH01 group and 94.2% in the PPH03 group. Conclusion. STARR performed for the treatment of hemorrhoidal disease associated with a large rectal prolapse is a safe and effective procedure. The use of the PPH-03 stapler instead of the PPH-01 guarantees a statistically significant reduction of intraoperative bleeding and a significant decrease of the operative time.