Suto T, et al. - Researchers in this paper presented the primary result of prospective randomized multicenter trial of new spray-type bio-absorbable adhesion barrier system (TCD-11091) against postoperative adhesion formation in patients who underwent laparotomy with ileostomy. They recognized using TCD-11091 as safe and in addition, was associated with significantly lower incidence of adhesion and severity of adhesions compared with non-treatment procedure.

Methods

• Researchers randomly assigned 126 patients to TCD-11091 group (n = 62) or non-treatment group (n = 62).
• The groups were similar regarding patient backgrounds.
• The observation was performed on 55 in the TCD-11091 group and 43 in the control group at the time of ileostomy closure (the second-look surgery).

Results

• Significantly lower incidence of adhesions observed at the second-look surgery was noticed in the TCD-11091 group (52.7 versus 90.7%; p < 0.001).
• For the secondary endpoints, significantly reduced incidence of wide extent adhesions (grade 2 or higher) was observed (38.2 versus 79.1%; p < 0.001).
• Regarding the severity of adhesions, the TCD-11091 group indicated significantly lower incidence of grade 2 or higher adhesions (47.3 versus 88.4%; p < 0.001).
• There appeared no differences in the incidence of adverse events between the TCD-11091 group and the non-treatment group (85.2 versus 75.4%; p = 0.225).