OBJECTIVE: To evaluate the efficacy of Interceed as an adjuvant in the prevention of postoperative adhesion reformation to the ovary, fallopian tube, and fimbria when used together with microsurgical techniques. DESIGN: Prospective, randomized, multicenter, controlled clinical study. SETTING:Normal human volunteers in an academic research environment. PATIENTS: Sixty-six women suffering from infertility due at least in part to bilateral tubal disease with bilateral adhesions attached to ovaries, fallopian tubes, and fimbriae. INTERVENTION: Adhesiolysis bilaterly through laparotomy with microsurgical techniques, application of Interceed on one of the sides randomly assigned not known by the surgeon before application, follow-up laparoscopy 4 to 10 weeks postoperatively, with each patient serving as her own control. MAIN OUTCOME MEASURES: Adhesion severity scores at all sites and number of adhesion free organs after laparotomy and follow-up laparoscopy. RESULTS: When the initial scores registered at the operation for fertility were compared with those registered at the second-look laparoscopy, the results indicated that gentle microsurgical techniques resulted in a significant reduction of postoperative adhesions. Adnexa, which were covered with Interceed, had significantly lower adhesion scores than the control adnexa, representing an improvement of 39% compared with microsurgery alone (control) in reducing adhesion reformation scores. When combined with microsurgical techniques, Interceed reduced adhesion reformation scores by 70%. The number of ovaries, fallopian tubes, and fimbriae without adhesions at the time of second-look laparoscopy was significantly increased by approximately twofold when organs were covered with Interceed. CONCLUSION: In a prospective, randomized, multicenter, controlled clinical study using a protocol in which other adjuvants have been shown not to be efficacious, Interceed was shown to reduce significantly the incidence and severity of adhesion reformation to the ovary, fallopian tube, and fimbria after infertility surgery.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of Interceed as an adjuvant in the prevention of postoperative adhesion reformation to the ovary, fallopian tube, and fimbria when used together with microsurgical techniques. DESIGN: Prospective, randomized, multicenter, controlled clinical study. SETTING: Normal human volunteers in an academic research environment. PATIENTS: Sixty-six women suffering from infertility due at least in part to bilateral tubal disease with bilateral adhesions attached to ovaries, fallopian tubes, and fimbriae. INTERVENTION: Adhesiolysis bilaterly through laparotomy with microsurgical techniques, application of Interceed on one of the sides randomly assigned not known by the surgeon before application, follow-up laparoscopy 4 to 10 weeks postoperatively, with each patient serving as her own control. MAIN OUTCOME MEASURES: Adhesion severity scores at all sites and number of adhesion free organs after laparotomy and follow-up laparoscopy. RESULTS: When the initial scores registered at the operation for fertility were compared with those registered at the second-look laparoscopy, the results indicated that gentle microsurgical techniques resulted in a significant reduction of postoperative adhesions. Adnexa, which were covered with Interceed, had significantly lower adhesion scores than the control adnexa, representing an improvement of 39% compared with microsurgery alone (control) in reducing adhesion reformation scores. When combined with microsurgical techniques, Interceed reduced adhesion reformation scores by 70%. The number of ovaries, fallopian tubes, and fimbriae without adhesions at the time of second-look laparoscopy was significantly increased by approximately twofold when organs were covered with Interceed. CONCLUSION: In a prospective, randomized, multicenter, controlled clinical study using a protocol in which other adjuvants have been shown not to be efficacious, Interceed was shown to reduce significantly the incidence and severity of adhesion reformation to the ovary, fallopian tube, and fimbria after infertility surgery.
Authors: Fausto Catena; Salomone Di Saverio; Michael D Kelly; Walter L Biffl; Luca Ansaloni; Vincenzo Mandalà; George C Velmahos; Massimo Sartelli; Gregorio Tugnoli; Massimo Lupo; Stefano Mandalà; Antonio D Pinna; Paul H Sugarbaker; Harry Van Goor; Ernest E Moore; Johannes Jeekel Journal: World J Emerg Surg Date: 2011-01-21 Impact factor: 5.469
Authors: Salomone Di Saverio; Fausto Catena; Federico Coccolini; Marica Galati; Nazareno Smerieri; Walter L Biffl; Luca Ansaloni; Gregorio Tugnoli; George C Velmahos; Massimo Sartelli; Cino Bendinelli; Gustavo Pereira Fraga; Michael D Kelly; Frederick A Moore; Vincenzo Mandalà; Stefano Mandalà; Michele Masetti; Elio Jovine; Antonio D Pinna; Andrew B Peitzman; Ari Leppaniemi; Paul H Sugarbaker; Harry Van Goor; Ernest E Moore; Johannes Jeekel Journal: World J Emerg Surg Date: 2013-10-10 Impact factor: 5.469