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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-07-25

AUTHORS

Takeshi Suto, Masahiko Watanabe, Takeshi Endo, Koji Komori, Masayuki Ohue, Yukihide Kanemitsu, Masaaki Itou, Yasumasa Takii, Toshimasa Yatsuoka, Manabu Shiozawa, Tetsushi Kinugasa, Hideki Ueno, Tadatoshi Takayama, Tadahiko Masaki, Hiroyuki Masuko, Hisanaga Horie, Masafumi Inomata

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. More... »

PAGES

1683-1691

Journal

TITLE

Journal of Gastrointestinal Surgery

ISSUE

10

VOLUME

21

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s11605-017-3503-1

DOI

http://dx.doi.org/10.1007/s11605-017-3503-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1090895874

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28744742


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25 schema:description 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.
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31 schema:keywords BackgroundPostoperative adhesions
32 ConclusionsUse
33 Prospective Randomized Multicenter Trial
34 ResultsOne hundred twenty
35 Terumo Corporation
36 adhesion
37 adhesion formation
38 adverse events
39 background
40 barrier system
41 bio
42 cause
43 chronic pelvic pain
44 closure
45 complications
46 control group
47 corporations
48 differences
49 endpoint
50 events
51 formation
52 grade 2
53 group
54 high adhesion
55 hundred twenty
56 ileostomy
57 ileostomy closure
58 incidence
59 incidence of adhesions
60 infertility
61 intestinal obstruction
62 laparoscopic surgery
63 laparotomy
64 lower incidence
65 major cause
66 method
67 multicenter trial
68 non-treatment group
69 observations
70 obstruction
71 order
72 pain
73 patient background
74 patients
75 pelvic pain
76 postoperative adhesion formation
77 postoperative adhesions
78 postoperative complications
79 primary results
80 procedure
81 randomized multicenter trial
82 results
83 second-look surgery
84 secondary endpoints
85 severity
86 severity of adhesions
87 single-blind study
88 sites
89 study
90 surgery
91 surgical procedures
92 system
93 time
94 treatment sites
95 trials
96 twenties
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