Department of Obstetrics and Gynecology, Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum, Hölkeskampring 40, 44625, Herne, Germany.
Arch Gynecol Obstet. 2022 Feb;305(2):415-423. doi: 10.1007/s00404-021-06331-0. Epub 2021 Nov 21.
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.
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.
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).
Intraoperative video colposcopy for LLETZ has minimal benefits at the cost of surgeons' satisfaction.
NCT04326049 (ClinicalTrials.gov).
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。
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。
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。
LLETZ 术中使用阴道镜的益处有限，但却降低了术者的满意度。
NCT04326049（ClinicalTrials.gov）。
