[Gunsight closure versus purse-string closure techniques in loop stoma reversal: a multicenter prospective randomized controlled trial].

Objective: To compare the wound healing time, Surgical site infection (SSI) rate and other postoperative outcomes between the gunsight closure and purse-string closure technique in loop stoma closure. Methods: Between November 2013 and December 2017, a total of 143 patients who underwent gunsight stoma reversal were included in this multicenter prospective randomized controlled trial. The patients were randomized to undergo gunsight (gunsight group, n=72) or purse-string closure technique (purse-string group, n=71). The primary endpoint was wound healing time. The second endpoints were the incidence of SSI, morbidity, and patient satisfaction. Statistical analysis between groups was performed using the t-test, repeated measures analysis of variance, Mann-Whitney U test, χ(2) test or Fisher's exact test. Results: There were 45 males and 27 females with age of 67 (11) (M(Q(R))) years in gunsight group, 42 males and 29 females with age of 65 (20) years in purse-string group. The body mass index, American Society of Anesthesiologist classification, comorbidities, primary diagnosis, the type of ostomy, intraoperative blood loss, perioperative complications, postoperative hospital stay, hospitalization cost, SSI rate and incisional hernia (stoma site) between the 2 groups were not significantly different (P>0.05). Although had a statistically longer operating time (80(10) minutes vs. 70(10) minutes, Z=-2.381, P=0.017), patients who underwent gunsight procedure and a significantly shorter wound healing time (17(2) days vs. 25(4) days, Z=-10.199, P<0.01), higher patient satisfaction score with regards to wound healing time (3(1) vs. 3(1), Z=-4.526, P<0.01), and higher total patient satisfaction score (25(3) vs. 25(3), Z=-2.529, P=0.011) compared with those who underwent purse-string procedure. Conclusions: The gunsight and purse-string techniques are effective procedures for stoma reversal and both have low SSI rate. The gunsight technique is associated with shorter wound healing time, higher levels of patient satisfaction compared with purse-string technique, and is recommended as the closure technique of choice.目的： 比较十字缝合和荷包缝合技术用于保护性肠造口还纳手术后皮肤关闭的有效性。 方法： 采用多中心前瞻性随机对照研究方法，于2013年11月至2017年12月，入组中华外科青年医师学术研究社结直肠外科研究组各成员单位的保护性肠造口还纳手术患者资料。样本量的确定采用优效性检验样本量计算，依据文献报道及前期工作基础，每组至少需要71例，两组合计需要样本量142例。术后评价切口疼痛情况、手术切口感染、切口愈合时间、术后患者满意度等。主要研究终点为切口愈合时间，次要研究终点为切口感染率、并发症发生率和患者满意度。组间比较采用独立样本t检验、重复测量方差分析、Mann-Whitney U检验、χ(2)检验、Fisher确切概率法等。 结果： 十字缝合组男性45例，女性27例，年龄67（11）岁[M（Q(R)）]；荷包缝合组男性42例，女性29例，年龄65（20）岁。两组体重指数、美国麻醉医师协会分级、合并症、初始手术诊断和造口部位（回肠或结肠）、术中出血量、围手术期并发症、术后住院时间、住院费用、切口感染率、术后切口疝均无明显差异。与荷包缝合组相比，十字缝合组的手术时间较长[80（10）min比70（10）min，Z=-2.381，P=0.017]，但切口愈合时间较短[17（2）d比25（4）d，Z=-10.199，P<0.01]，满意度调查中的愈合时间评分[3（1）比3（1），Z=-4.526，P<0.01]和总体满意评分[25（3）比25（3），Z=-2.529，P=0.011]优于荷包缝合组。 结论： 十字缝合与荷包缝合具有相似的切口感染率，均可有效用于造口还纳后的皮肤关闭。十字缝合技术的切口愈合时间更短，患者满意度评分更高，可作用肠造口还纳后皮肤关闭的重要技术选择。.