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

Background 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 ea...

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Bibliographic Details
Published in:Journal of gastrointestinal surgery 2017-10, Vol.21 (10), p.1683-1691
Main Authors: Suto, Takeshi, Watanabe, Masahiko, Endo, Takeshi, Komori, Koji, Ohue, Masayuki, Kanemitsu, Yukihide, Itou, Masaaki, Takii, Yasumasa, Yatsuoka, Toshimasa, Shiozawa, Manabu, Kinugasa, Tetsushi, Ueno, Hideki, Takayama, Tadatoshi, Masaki, Tadahiko, Masuko, Hiroyuki, Horie, Hisanaga, Inomata, Masafumi
Format: Article
Language:English
Subjects:
Absorbable Implants
Adult
Aged
Colorectal cancer
Female
Gastroenterology
Gastrointestinal surgery
Gels
Humans
Ileostomy
Incidence
Japan
Laparotomy
Male
Medicine
Medicine & Public Health
Middle Aged
Original
Original Article
Ostomy
Polymers - therapeutic use
Postoperative Complications - epidemiology
Postoperative Complications - etiology
Postoperative Complications - prevention & control
Postoperative period
Prospective Studies
Single-Blind Method
Surgery
Tissue Adhesions - epidemiology
Tissue Adhesions - etiology
Tissue Adhesions - prevention & control
Treatment Outcome
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Summary:Background 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. Methods and Results 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  
ISSN:1091-255X
1873-4626
DOI:10.1007/s11605-017-3503-1