转化区大环形切除术的喷雾与强制凝血：一项随机试验

Spray Versus Forced Coagulation in Large Loop Excision of the Transformation Zone: A Randomized Trial.

作者信息

Hilal Ziad, Mavrommati Georgia, Foerster Claudia, Rezniczek Günther A, Hefler Lukas A, Tempfer Clemens B

机构信息

1Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany, and the 2Department of Obstetrics and Gynecology, Krankenhaus der Barmherzigen Schwestern, Linz, Austria.

出版信息

J Low Genit Tract Dis. 2016 Apr;20(2):169-73. doi: 10.1097/LGT.0000000000000177.

DOI:10.1097/LGT.0000000000000177

PMID:26796660

Abstract

OBJECTIVE

Large loop excision of the transformation zone (LLETZ) is the standard surgical treatment for cervical dysplasia. The optimal way to achieve local hemostasis in women undergoing LLETZ is unknown.

MATERIALS AND METHODS

In a prospective, randomized trial, we compared spray coagulation and forced coagulation in women undergoing LLETZ in a 1:1 ratio. The primary endpoint was time to complete local hemostasis (TCLH). Secondary endpoints were blood loss (Δ hemoglobin before and after LLETZ), pain (numerical visual analog scale, 5-step graphical visual analog scale measured 2-3 hours after LLETZ), and perioperative/postoperative complications (intraoperative need for sutures, postoperative bleeding, infection, and unscheduled readmission). Analysis was by intention to treat.

RESULTS

One hundred fifty-one women were enrolled and were eligible for analysis. Mean (SD) TCLH in 80 women with forced coagulation was 43.3 (38.5) and 28.9 (22.9) seconds in 71 women with spray coagulation (p < 0.001). The secondary endpoints blood loss (Δ hemoglobin, -0.8 [0.8] vs -0.7 [1.1]; p = 0.115), pain (numerical visual analog scale, 4.1 [0.9] vs 4.2 [0.9]; p = 0.283, graphical visual analog scale (1.9 [1.3] vs 1.8 [1.3]; p = 0.888), and perioperative/postoperative complications (6/71 [8%] vs 7/80 [9%]; p = 0.822) were comparable between the 2 arms. In a multivariate analysis, coagulation method (odds ratio = 0.18; 95% CI = 0.09-0.38; p < 0.001) and size of the cervix (odds ratio = 2.43; 95% CI = 1.16-5.15; p = 0.021) were independent predictors of TCLH.

CONCLUSIONS

Spray coagulation is superior to forced coagulation in women undergoing LLETZ and should be used as the standard approach.

摘要

目的

宫颈转化区大环形切除术（LLETZ）是宫颈发育异常的标准外科治疗方法。LLETZ 手术中实现局部止血的最佳方法尚不清楚。

材料与方法

在一项前瞻性随机试验中，我们将接受 LLETZ 手术的女性按 1:1 的比例随机分为喷雾凝固组和强制凝固组。主要终点是完成局部止血的时间（TCLH）。次要终点包括失血量（LLETZ 前后血红蛋白差值）、疼痛（数字视觉模拟量表，LLETZ 后 2 - 3 小时测量的 5 级图形视觉模拟量表）以及围手术期/术后并发症（术中缝线需求、术后出血、感染和计划外再入院）。分析采用意向性分析。

结果

共纳入 151 名女性并符合分析条件。80 名接受强制凝固的女性的平均（标准差）TCLH 为 43.3（38.5）秒，71 名接受喷雾凝固的女性为 28.9（22.9）秒（p < 0.001）。次要终点方面，两组在失血量（血红蛋白差值，-0.8 [0.8]对 -0.7 [1.1]；p = 0.115）、疼痛（数字视觉模拟量表，4.1 [0.9]对 4.2 [0.9]；p = 0.283，图形视觉模拟量表（1.9 [1.3]对 1.8 [1.3]；p = 0.888）以及围手术期/术后并发症（6/71 [8%]对 7/80 [9%]；p = 0.822）方面相当。在多变量分析中，凝固方法（比值比 = 0.18；95%置信区间 = 0.09 - 0.38；p < 0.001）和宫颈大小（比值比 = 2.43；95%置信区间 = 1.16 - 5.15；p = 0.021）是 TCLH 的独立预测因素。