This study was sponsored by TERUMO Corp, Japan.
This manuscript is submitted to randomized clinical trial.
This study and findings are not presented any society and meetings.
Postoperative 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.
One 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).
Use of TCD-11091 was safe and associated with significantly lower incidence of adhesion and severity of adhesions compared with non-treatment procedure.
Diamond MP, Nezhat F. Adhesions after resection of ovarian endometriomas. Fertil Steril. 1993;59:935–936 CrossRef
Cezar, Cristina, et al. How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study. Best Practice & Research Clinical Obstetrics & Gynaecology, 2016, 35: 84–96. CrossRef
Kusunoki M et al. [Anti-adhesion barrier "Seprafilm" after abdominal surgery]. Progress in Medicine 2001;21(3):157–61
Vrijiland et al. Fewer intraperitoneal adhesions with use of hyaluronic acid-arboxymethylcellulose membrane. Ann Surg 2002;235(2):193–9 CrossRef
Becker et al. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg. 1996 Oct;183(4):297–306.PubMed
Johns, D. A., R. Ferland, and R. Dunn. Initial feasibility study of a sprayable hydrogel adhesion barrier system in patients undergoing laparoscopic ovarian surgery. J Am Assoc Gynecol Laparosc 10.3 (2003): 334–338.
- The Primary Result of Prospective Randomized Multicenter Trial of New Spray-Type Bio-absorbable Adhesion Barrier System (TCD-11091) Against Postoperative Adhesion Formation
- Springer US
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