A prospective multi-center registry concerning the clinical performance of laparoscopic colorectal surgery using an absorbable adhesion barrier (INTERCEED®) made of oxidized regenerated cellulose

Jun Watanabe; Fumio Ishida; Hideyuki Ishida; Yosuke Fukunaga; Kazuteru Watanabe; Masanori Naito; Masahiko Watanabe

doi:10.1007/s00595-019-01816-7

A prospective multi-center registry concerning the clinical performance of laparoscopic colorectal surgery using an absorbable adhesion barrier (INTERCEED^®) made of oxidized regenerated cellulose

Surg Today. 2019 Oct;49(10):877-884. doi: 10.1007/s00595-019-01816-7. Epub 2019 Apr 29.

Authors

Jun Watanabe¹, Fumio Ishida², Hideyuki Ishida³, Yosuke Fukunaga⁴, Kazuteru Watanabe⁵, Masanori Naito⁶, Masahiko Watanabe⁶

Affiliations

¹ Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. nabe-jun@comet.ocn.ne.jp.
² Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan.
³ Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
⁴ Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
⁵ Department of Surgery, NTT Medical Center Tokyo, Tokyo, Japan.
⁶ Department of Colorectal Surgery, Kitasato University School of Medicine, Sagamihara, Japan.

Abstract

Purpose: The aim of this prospective multi-center registry was to evaluate the safety and clinical performance of INTERCEED^® in laparoscopic colorectal surgery.

Methods: This study was a prospective, multi-center, single-arm registry wherein patients who received INTERCEED^® in laparoscopic colorectal surgery were registered consecutively (UMIN-CTR 00001872). The primary outcome was the incidence rate of postoperative adhesive small intestinal obstruction within 6 months. The secondary outcomes were reoperation related to postoperative bleeding and anastomotic leak, surgical site infection (SSI) and anastomotic leak.

Results: Between March 2012 and March 2015, a total of 202 patients were enrolled from six institutions. INTERCEED^® was not applied in two patients, so 200 patients were analyzed using the full analysis set population. The incidence rate of postoperative adhesive intestinal obstruction was 1.0% (2/200). The total SSI rate was 3.5% (7/200), the deep incisional SSI rate was 0.0% (0/200), and the organ SSI rate was 0.0% (0/200). The incidence of anastomotic leak was 1.0% (2/200). Reoperation was performed in two cases: one for anastomotic leak and the other as cardiac surgery due to heart disease.

Conclusions: Using INTERCEED^® in laparoscopic colorectal surgery is safe and may be useful for preventing postoperative adhesive small intestinal obstruction.

Keywords: Adhesion barrier; Colorectal surgery; INTERCEED®; Oxidized regenerated cellulose; Small bowel obstruction.

MeSH terms

Adult
Aged
Aged, 80 and over
Anastomotic Leak / epidemiology
Cellulose, Oxidized*
Colon / surgery*
Digestive System Surgical Procedures / methods*
Female
Humans
Incidence
Intestinal Obstruction / epidemiology
Intestinal Obstruction / prevention & control*
Intestine, Small
Laparoscopy / methods*
Male
Middle Aged
Multicenter Studies as Topic
Postoperative Complications / epidemiology
Postoperative Complications / prevention & control*
Postoperative Hemorrhage / epidemiology
Prospective Studies
Rectum / surgery*
Registries
Reoperation
Safety
Surgical Wound Infection / epidemiology
Time Factors
Treatment Outcome

Substances

Cellulose, Oxidized