Skip to main content
main-content

25.07.2017 | Original Article | Ausgabe 10/2017 Open Access

Journal of Gastrointestinal Surgery 10/2017

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

Zeitschrift:
Journal of Gastrointestinal Surgery > Ausgabe 10/2017
Autoren:
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
Wichtige Hinweise
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.

Abstract

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 < 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).

Conclusions

Use of TCD-11091 was safe and associated with significantly lower incidence of adhesion and severity of adhesions compared with non-treatment procedure.

Unsere Produktempfehlungen

e.Med Interdisziplinär

Kombi-Abonnement

Mit e.Med Interdisziplinär erhalten Sie Zugang zu allen CME-Fortbildungen und Premium-Inhalten der Fachzeitschriften, inklusive eines Print-Abos.

e.Med Chirurgie

Kombi-Abonnement

Mit e.Med Chirurgie erhalten Sie Zugang zu CME-Fortbildungen des Fachgebietes Chirurgie, den Premium-Inhalten der chirurgischen Fachzeitschriften, inklusive einer gedruckten chirurgischen Zeitschrift Ihrer Wahl.

Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 10/2017

Journal of Gastrointestinal Surgery 10/2017Zur Ausgabe

Neu im Fachgebiet Chirurgie

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Chirurgie und bleiben Sie gut informiert – ganz bequem per eMail.

Bildnachweise