title: PPH-01 versus PPH-03 to perform STARR for the treatment of hemorrhoids associated with large internal rectal prolapse: a prospective multicenter randomized trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors: Villa delle Querce Hospital, Naples, Italy. ar@colonproctologia.eu
authors: Adolfo
authors: A
authors: Renzi
authors: Antonio
authors: A
authors: Brillantino
authors: Giandomenico
authors: G
authors: Di Sarno
authors: Francesco
authors: F
authors: D'Aniello
authors: Alfredo
authors: A
authors: Giordano
authors: Alberto
authors: A
authors: Stefanuto
authors: Daniele
authors: D
authors: Aguzzi
authors: Antonio
authors: A
authors: Daffinà
authors: Francesco
authors: F
authors: Ceci
authors: Giuseppe
authors: G
authors: D'Oriano
authors: Massimo
authors: M
authors: Mercuri
authors: Alfonso
authors: A
authors: Alderisio
authors: Luis
authors: L
authors: Perretta
authors: Francesco
authors: F
authors: Carrino
authors: Giovanni
authors: G
authors: Sernia
authors: Ettore
authors: E
authors: Greco
authors: Marcello
authors: M
authors: Picchio
authors: Giuseppe
authors: G
authors: Marino
authors: Angelo
authors: A
authors: Goglia
authors: Amilcare
authors: A
authors: Trombetti
authors: Biagio
authors: B
authors: De Pascalis
authors: Sabatino
authors: S
authors: Panella
authors: Osvaldo
authors: O
authors: Bochicchio
authors: Alfredo
authors: A
authors: Bandini
authors: Luca
authors: L
authors: Del Re
authors: Francesco
authors: F
authors: Longo
authors: Osvaldo
authors: O
authors: Micera
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016009:Chi-Square Distribution; D005260:Female; D006484:Hemorrhoids / Q000150:complications / Q000601:surgery*; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D012005:Rectal Prolapse / Q000150:complications / Q000601:surgery*; D013528:Surgical Staplers; D017792:Surgical Stapling / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome