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

BACKGROUND: Anastomotic complications, including leaks, stenoses, and bleeding, cause considerable mortality and morbidity after colorectal surgery.

OBJETIVE: The purpose of this work was to evaluate the effectiveness of bioabsorbable staple line reinforcement in reducing colorectal anastomotic complications.

DESIGN: This was a prospective randomized clinical study.

SETTINGS: This study was conducted at a university hospital within a specialized colorectal unit.

PATIENTS: Patients 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.

INTERVENTION: Patients were prospectively randomly assigned to reinforcement of circular stapled anastomosis with a bioabsorbable device versus stapled circular anastomosis without reinforcement.

MAIN OUTCOME MEASURES: The 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.

RESULTS: Baseline 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.

LIMITATIONS: Sample 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.

CONCLUSIONS: The 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).