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Surg Innov ; 18(3): 241-7, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21737467

ABSTRACT

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.


Subject(s)
Hemorrhoids/surgery , Rectal Prolapse/surgery , Surgical Staplers , Surgical Stapling/methods , Adolescent , Adult , Aged , Chi-Square Distribution , Female , Hemorrhoids/complications , Humans , Incidence , Italy/epidemiology , Male , Middle Aged , Postoperative Complications/epidemiology , Rectal Prolapse/complications , Time Factors , Treatment Outcome
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