• Dis. Colon Rectum · Oct 2014

    Randomized Controlled Trial

    Preventing complications in colorectal anastomosis: results of a randomized controlled trial using bioabsorbable staple line reinforcement for circular stapler.

    • Carlos Placer, Jose M Enríquez-Navascués, Garazi Elorza, Ander Timoteo, Jose A Mugica, Nerea Borda, Yolanda Saralegui, and Jose L Elósegui.
    • Colorectal Unit, Service of General and Digestive Surgery, Hospital Universitario Donostia, San Sebastian, Spain.
    • Dis. Colon Rectum. 2014 Oct 1; 57 (10): 1195-201.

    BackgroundAnastomotic complications, including leaks, stenoses, and bleeding, cause considerable mortality and morbidity after colorectal surgery.ObjetiveThe purpose of this work was to evaluate the effectiveness of bioabsorbable staple line reinforcement in reducing colorectal anastomotic complications.DesignThis was a prospective randomized clinical study.SettingsThis study was conducted at a university hospital within a specialized colorectal unit.PatientsPatients undergoing left colon resection for a benign or malignant condition were eligible. A total of 302 patients participated, including 154 control subjects and 148 with reinforcement.InterventionPatients were prospectively randomly assigned to reinforcement of circular stapled anastomosis with a bioabsorbable device versus stapled circular anastomosis without reinforcement.Main Outcome MeasuresThe primary end point was the rate of pooled incidences of anastomotic complications (leakage, bleeding, or stenosis). Secondary outcomes were the rate of reoperations and the length of hospital stay.ResultsBaseline characteristics were similar between both groups. Intention-to-treat analysis revealed that there were no significant differences in the pooled incidences of anastomotic complications (p = 0.821). Regarding individual complications, we did not observe statistical differences between groups, including leakage (6.6% vs 4.8%; p = 0.518), hemorrhage (1.4% vs 1.3%; p = 0.431), or stenosis (2.9% vs 6.8%; p = 0.128). Again, no significant differences were observed in length of stay (7 days; p = 0.242) or rate of reoperation (7.3% vs 9.6%; p = 0.490). A patient (0.3%) in the control group died.LimitationsSample size calculation was performed including all 3 of the complications, which may render it underpowered to detect differences regarding a specific complication. Anastomoses located within 5 cm from the anal verge were excluded from the study.ConclusionsThe results obtained show that bioabsorbable staple line reinforcement in a colorectal anastomosis >5 cm from the anal verge does not reduce the rate of pooled anastomotic complications (ie, leaks, bleeding, or stenosis).

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