阴道镜下宫颈环形电切术与冷刀锥切术治疗宫颈转化区病变的比较：一项随机试验

Video colposcopy versus headlight for large loop excision of the transformation zone (LLETZ): a randomised trial.

机构信息

Department of Obstetrics and Gynecology, Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum, Hölkeskampring 40, 44625, Herne, Germany.

出版信息

Arch Gynecol Obstet. 2022 Feb;305(2):415-423. doi: 10.1007/s00404-021-06331-0. Epub 2021 Nov 21.

DOI:10.1007/s00404-021-06331-0

PMID:34802113

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8606170/

Abstract

PURPOSE

To compare resected cone mass and resection margin status when performing Large Loop Excision of the Transformation Zone (LLETZ) using video colposcopy (LLETZ-VC) versus a headlight (LLETZ-HL) in women with cervical dysplasia.

METHODS

Prospective, randomised trial (monocentric) at a specialised cervical dysplasia unit in a University Hospital. Women with a biopsy-proven CIN2 + or persisting CIN1 or diagnostic LLETZ were recruited and randomised. LLETZ was performed either under video colposcopic vision or using a standard surgical headlight. The primary endpoint was resected cone mass. Secondary endpoints were the rate of involved margins, fragmentation of the specimen, procedure time, time to complete haemostasis (TCH), blood loss, pain, intra- and postoperative complications, and surgeon preference.

RESULTS

LLETZ-VC and LLETZ-HL (109 women each) had comparable cone masses (1.57 [0.98-2.37] vs. 1.67 [1.15-2.46] grams; P = 0.454). TCH was significantly shorter in the LLETZ-VC arm (60 [41-95.2] vs. 90 [47.2-130.2] seconds; P = 0.008). There was no statistically significant difference in involved resection margins (6/87 [6.5%] vs. 16/101 [13.7%], P = 0.068) and postoperative complications (13/82 [13.7%] vs. 22/72 [23.4%], P = 0.085). Patient-reported outcomes favoured LLETZ-VC with a lower use of analgesics (6/80 [7.0%] vs. 17/87 [16.3%]; P = 0.049). However, LLETZ-VC was more difficult to perform with significantly lower ratings for handling (7 [5-9] vs. 9 [8-10]; P < 0.001) and general satisfaction (7.5 [5-9] vs. 10 [8-10]; P < 0.001).

CONCLUSION

Intraoperative video colposcopy for LLETZ has minimal benefits at the cost of surgeons' satisfaction.

CLINICAL TRIAL REGISTRATION

NCT04326049 (ClinicalTrials.gov).

摘要

目的

比较在阴道镜下（LLETZ-VC）和头灯下（LLETZ-HL）行大环形电切术（LLETZ）时切除的锥形组织质量和切缘状态，用于治疗宫颈上皮内瘤变（CIN）的妇女。

方法

这是一项在大学医院的宫颈上皮内瘤变专科单位进行的前瞻性、随机临床试验（单中心）。招募了经活检证实为 CIN2+或持续存在 CIN1 或诊断性 LLETZ 的患者，并进行了随机分组。LLETZ 分别在阴道镜直视下或使用标准手术头灯下进行。主要终点是切除的锥形组织质量。次要终点是切缘受累的发生率、标本碎裂、手术时间、止血完成时间（TCH）、出血量、疼痛、术中及术后并发症以及术者偏好。

结果

LLETZ-VC 和 LLETZ-HL（各 109 例）的锥形组织质量相当（1.57 [0.98-2.37] 与 1.67 [1.15-2.46] 克；P=0.454）。LLETZ-VC 组的 TCH 明显缩短（60 [41-95.2] 与 90 [47.2-130.2] 秒；P=0.008）。切缘受累的发生率无统计学差异（6/87 [6.5%] 与 16/101 [13.7%]，P=0.068）和术后并发症（13/82 [13.7%] 与 22/72 [23.4%]，P=0.085）。患者报告的结局有利于 LLETZ-VC，其镇痛药使用率较低（6/80 [7.0%] 与 17/87 [16.3%]；P=0.049）。然而，LLETZ-VC 操作难度较大，处理（7 [5-9] 与 9 [8-10]；P<0.001）和总体满意度（7.5 [5-9] 与 10 [8-10]；P<0.001）评分明显较低。