Surgery today · 2019
A prospective multi-center registry concerning the clinical performance of laparoscopic colorectal surgery using an absorbable adhesion barrier (INTERCEED®) made of oxidized regenerated cellulose.
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Watanabe Jun, Ishida Fumio, Ishida Hideyuki, Fukunaga Yosuke, Watanabe Kazuteru, Naito Masanori, Watanabe Masahiko
Аннотация
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.
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.
Предметные рубрики MeSH
AdultAgedAged, 80 and overAnastomotic LeakCellulose, OxidizedColonDigestive System Surgical ProceduresFemaleHumansIncidenceIntestinal ObstructionIntestine, SmallLaparoscopyMaleMiddle AgedMulticenter Studies as TopicPostoperative ComplicationsPostoperative HemorrhageProspective StudiesRectumRegistriesReoperationSafetySurgical Wound InfectionTime FactorsTreatment Outcome