Department of General, Vascular and Thoracic Surgery, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin,
Langenbecks Arch Surg. 2013 Mar;398(3):467-74. doi: 10.1007/s00423-012-0904-1.
Recurrent Crohn's disease activity at the site of anastomosis after ileocecal resection is of great surgical importance. This prospective randomized multi-center trial with an estimated case number of 224 patients was initially planned to investigate whether stapled side-to-side anastomosis, compared to hand-sewn end-to-end anastomosis, results in a decreased recurrence of Crohn's disease following ileocolic resection (primary endpoint). The secondary endpoint was to focus on the early postoperative results comparing both surgical methods. The study was terminated early due to insufficient patient recruitment and because another large study investigated the same question, while our trial was ongoing.
Patients with stenosing ileitis terminalis in Crohn's disease who underwent an ileocolic resection were randomized to side-to-side or end-to-end anastomosis. Due to its early discontinuation, our study only investigated the secondary endpoints, the early postoperative results (complications: bleeding, wound infection, anastomotic leakage, first postoperative stool, duration of hospital stay).
From February 2006 until June 2010, 67 patients were enrolled in nine participating centers. The two treatment groups were comparable to their demographic and pre-operative data. BMI and Crohn's Disease Activity Index were 22.2 (± 4.47) and 200.5 (± 73.66), respectively, in the side-to-side group compared with 23.3 (± 4.99) and 219.6 (± 89.03) in the end-to-end group. The duration of surgery was 126.7 (± 42.8) min in the side-to-side anastomosis group and 137.4 (± 51.9) min in the end-to-end anastomosis group. Two patients in the end-to-end anastomosis group developed an anastomotic leakage (6.5%). Impaired wound healing was found in 13.9% of the side-to-side anastomosis group, while 6.5% of the end-to-end anastomosis group developed this complication. The duration of hospital stay was comparable in both groups with 9.9 (± 3.93) and 10.4 (± 3.26) days, respectively.
Because of the early discontinuation of the study, it is not possible to provide a statement about the perianastomotic recurrence rates regarding the primary endpoint. With regard to the early postoperative outcome, we observed no difference between the two types of anastomosis.
回肠末端切除术后吻合口处克罗恩病的复发对手术治疗具有重要意义。本研究为前瞻性、随机、多中心临床试验，预计纳入 224 例患者，旨在探讨吻合器吻合与手工端端吻合相比，是否可降低回肠结肠切除术后克罗恩病的复发率（主要终点）。次要终点为比较两种手术方法的早期术后结果。由于入组患者数量不足，且另一项大型研究正在进行，本研究提前终止。
克罗恩病末端回肠炎狭窄患者行回肠结肠切除术，随机分为侧侧吻合组或端端吻合组。由于提前终止，本研究仅调查了次要终点，即早期术后结果（并发症：出血、伤口感染、吻合口漏、首次术后排便、住院时间）。
2006 年 2 月至 2010 年 6 月，9 个参与中心共纳入 67 例患者。两组患者的人口统计学和术前数据相似。侧侧吻合组的 BMI 和克罗恩病活动指数分别为 22.2（±4.47）和 200.5（±73.66），端端吻合组分别为 23.3（±4.99）和 219.6（±89.03）。侧侧吻合组的手术时间为 126.7（±42.8）min，端端吻合组为 137.4（±51.9）min。端端吻合组有 2 例患者发生吻合口漏（6.5%）。侧侧吻合组有 13.9%的患者出现伤口愈合不良，端端吻合组有 6.5%的患者出现该并发症。两组患者的住院时间相似，分别为 9.9（±3.93）和 10.4（±3.26）天。
由于研究提前终止，无法对主要终点的吻合口复发率提供结论。就早期术后结果而言，我们观察到两种吻合方式之间无差异。
