Placer Carlos, Enríquez-Navascués Jose M, Elorza Garazi, Timoteo Ander, Mugica Jose A, Borda Nerea, Saralegui Yolanda, Elósegui Jose L
Colorectal Unit, Service of General and Digestive Surgery, Hospital Universitario Donostia, San Sebastian, Spain.
Dis Colon Rectum. 2014 Oct;57(10):1195-201. doi: 10.1097/DCR.0000000000000207.
Anastomotic complications, including leaks, stenoses, and bleeding, cause considerable mortality and morbidity after colorectal surgery.
The purpose of this work was to evaluate the effectiveness of bioabsorbable staple line reinforcement in reducing colorectal anastomotic complications.
This was a prospective randomized clinical study.
This study was conducted at a university hospital within a specialized colorectal unit.
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.
Patients were prospectively randomly assigned to reinforcement of circular stapled anastomosis with a bioabsorbable device versus stapled circular anastomosis without reinforcement.
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.
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.
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.
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).
吻合口并发症，包括渗漏、狭窄和出血，在结直肠手术后会导致相当高的死亡率和发病率。
本研究旨在评估生物可吸收吻合钉加固在降低结直肠吻合口并发症方面的有效性。
这是一项前瞻性随机临床研究。
本研究在一家大学医院的专业结直肠科进行。
因良性或恶性疾病接受左半结肠切除术的患者符合条件。共有302名患者参与，其中154名作为对照组，148名接受加固治疗。
患者被前瞻性随机分配至使用生物可吸收装置加固圆形吻合钉吻合术组和未进行加固的圆形吻合钉吻合术组。
主要终点是吻合口并发症（渗漏、出血或狭窄）的合并发生率。次要结局是再次手术率和住院时间。
两组的基线特征相似。意向性分析显示，吻合口并发症的合并发生率无显著差异（p = 0.821）。对于个体并发症，我们未观察到组间的统计学差异，包括渗漏（6.6%对4.8%；p = 0.518）、出血（1.4%对1.3%；p = 0.431）或狭窄（2.9%对6.8%；p = 0.128）。同样，住院时间（7天；p = 0.242）或再次手术率（7.3%对9.6%；p = 0.490）也无显著差异。对照组有1名患者（0.3%）死亡。
样本量计算纳入了所有3种并发症，这可能使其检测特定并发症差异的能力不足。距肛缘5 cm以内的吻合口被排除在研究之外。
研究结果表明，在距肛缘>5 cm的结直肠吻合术中使用生物可吸收吻合钉加固并不能降低吻合口并发症（即渗漏、出血或狭窄）的合并发生率。
