The Primary Result of Prospective Randomized Multicenter Trial of New Spray-Type Bio-absorbable Adhesion Barrier System (TCD-11091) Against Postoperative Adhesion Formation

Abstract

BackgroundPostoperative adhesions are the major cause of postoperative complications including intestinal obstruction, infertility, and chronic pelvic pain. In order to reduce postoperative adhesions, Terumo Corporation (Tokyo, Japan) has developed an adhesion barrier system (TCD-11091) which is easy to use at the treatment site in various surgical procedures including laparoscopic surgeries. We conducted a prospective randomized single-blind study in patients who underwent laparotomy with ileostomy.Methods and ResultsOne hundred twenty-six patients were randomly assigned to TCD-11091 group (n = 62) or non-treatment group (n = 62). Patient backgrounds were similar between the groups. At the time of ileostomy closure (the second-look surgery), the observation was performed on 55 in the TCD-11091 group and 43 in the control group. The incidence of adhesions observed at the second-look surgery was significantly lower in the TCD-11091 group (52.7 versus 90.7%; p < 0.001). For the secondary endpoints, the incidence of wide extent adhesions (grade 2 or higher) was significantly reduced (38.2 versus 79.1%; p < 0.001). Regarding the severity of adhesions, the incidence of grade 2 or higher adhesions was also significantly lower in the TCD-11091 group (47.3 versus 88.4%; p < 0.001). No differences in the incidence of adverse events were found between the TCD-11091 group and the non-treatment group (85.2 versus 75.4%; p = 0.225).ConclusionsUse of TCD-11091 was safe and associated with significantly lower incidence of adhesion and severity of adhesions compared with non-treatment procedure.

Evaluation of adhesion barrier types in a rat hepatectomy-induced adhesion model

“…AdSpray is a bioresorbable hydrogel consisting of N-hydroxysuccinimide-modi ed carboxymethyl dextrin and, when applied to injured tissues using a sprayer, it forms a site-speci c physical barrier [21]. A clinical trial demonstrated that it could reduce the incidence, severity, and extent of adhesions following laparotomy in gastrointestinal surgery [22]. Owing to its spray form, it is easy to use in laparoscopic surgery, and its effectiveness has been reported in a laparoscopic gynecological adhesion model in large animals [23].…”

“…Owing to its spray form, it is easy to use in laparoscopic surgery, and its effectiveness has been reported in a laparoscopic gynecological adhesion model in large animals [23]. To our knowledge, although there is some evidence in the literature about the adhesion prevention effect of AdSpray in gastrointestinal or gynecological surgery [21,22,24], evidence in hepatectomy surgery has yet to be published.…”

Evaluation of adhesion barrier types in a rat hepatectomy-induced adhesion model

“…AdSpray is a bioresorbable hydrogel consisting of N-hydroxysuccinimide-modified carboxymethyl dextrin and, when applied to injured tissues using a sprayer, it forms a site-specific physical barrier [21]. A clinical trial demonstrated that it could reduce the incidence, severity, and extent of adhesions following laparotomy in gastrointestinal surgery [22]. Owing to its spray form, it is easy to use in laparoscopic surgery, and its effectiveness has been reported in a laparoscopic gynecological adhesion model in large animals [23].…”

Safety of Stoma Closure within 90 Days after Low Anterior Resection and Diverting Ileostomy

“…Our institution adopts a purse-string closure technique, which is associated with signi cantly fewer SSIs and better cosmetic outcomes with stoma reversal than those associated with conventional primary closure [19], thus potentially reducing the postoperative wound infection rate even after early stoma closure. Furthermore, applying anti-adhesive materials [20] around the stoma could reduce the technical di culties experienced and further improve the results of early stoma closure.…”