A randomized trial of the Fischer cone biopsy excisor and loop electrosurgical excision procedure.
A randomized trial of the Fischer cone biopsy excisor and loop electrosurgical excision procedure.
复制标题
费歇尔锥形活检切除器和环形电外科切除程序的随机试验。
DOI：
10.1097/01.aog.0000139517.26003.fc
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发表时间：
2004
影响因子：
7.2
通讯作者：
Crowthers,Laina
中科院分区：
文献类型：
--
作者：
Boardman,LoriA;Steinhoff,MargaretM;Shackelton,Rebecca;Weitzen,Sherry;Crowthers,Laina
目的：比较使用 Fischer 锥形活检切除器或环形电外科切除术 (LEEP) 获得的标本的数量、切缘可解释性、切除的充分性和易用性。 方法：100 名年龄在 13 岁及以上的符合条件的患者被随机分配接受 Fischer 锥形活检切除器或 LEEP 治疗。资格标准包括：(1) 宫颈上皮内瘤变 (CIN) 2 或 3，(2) 持续性 CIN 1，或 (3) 细胞学/组织学差异。切除后，提供者按照 1 到 10 的等级对易用性进行排名。病理学家对手术类型不知情，分析了标本的切缘可解释性和切除的充分性。在研究开始之前，我们计算出总共需要 100 名患者来证明 LEEP 80% 和锥形活检切除器 99% 的可解释切缘率存在显着差异（功效 80%，α=.05）。 结果：在调整易用性、病灶大小和肿瘤程度后，锥形活检切除器产生单个样本的可能性并不比 LEEP 更高（74% 与 LEEP 相比）。 63%，相对风险 [RR] 0.93，95% 置信区间 [CI] 0.79−1.11），产生具有可解释边缘的标本（65% 与 73%，RR 0.97，95% CI 0.78–1.22），或导致完全切除宫颈病变（LEEP 的 72% 与 62%，RR 1.08， 95% CI 0.77–1.52）。提供者发现他们使用 Fischer 锥形活检切除器和 LEEP 锥形活检的体验相似，即使在调整培训年份和之前的经验后也是如此（RR 0.95，95% CI 0.72–1.24）。 结论：Fischer 锥形活检切除器和 LEEP 在最终标本数量、边缘可解释性和易用性方面表现相似。 证据级别：I The Fischer锥形切除器和环形电外科切除程序在最终标本的数量、边缘可解释性和易用性方面表现相似。
OBJECTIVE:To compare specimens obtained with the Fischer cone biopsy excisor or loop electrosurgical excision procedure (LEEP) with respect to number of specimens obtained, margin interpretability, adequacy of excision, and ease of use.METHODS:One hundred eligible patients aged 13 years and older were randomly assigned to treatment with the Fischer cone biopsy excisor or LEEP. Eligibility criteria included:(1) cervical intraepithelial neoplasia (CIN) 2 or 3,(2) persistent CIN 1, or (3) cytologic/histologic discrepancy. Following excision, providers ranked ease of use on a scale of 1 to 10. A pathologist blinded to procedure type analyzed specimens for margin interpretability and adequacy of excision. Before study initiation we calculated that a total of 100 patients would be required to demonstrate a significant difference in the interpretable margin rate of 80% for LEEP and 99% for cone biopsy excisor (power 80%, α=. 05).RESULTS:After adjustment for ease of use, lesion size, and degree of neoplasia, the cone biopsy excisor was no more likely to result in a single specimen than LEEP (74% versus 63%, relative risk [RR] 0.93, 95% confidence interval [CI] 0.79− 1.11), to result in a specimen with interpretable margins (65% versus 73%, RR 0.97, 95% CI 0.78–1.22), or to result in a fully excised cervical lesion (72% versus 62% for LEEPs, RR 1.08, 95% CI 0.77–1.52). Providers found their experiences with both Fischer cone biopsy excisor and LEEP cone biopsies to be similar, even after adjustment for year of training and previous experience (RR 0.95, 95% CI 0.72–1.24).CONCLUSION:The Fischer cone biopsy excisor and LEEP performed similarly with respect to the number of final specimens, margin interpretability, and ease of use.LEVEL OF EVIDENCE:IThe Fischer cone excisor and loop electrosurgical excision procedure performed similarly with respect to the number of final specimens, margin interpretability, and ease of use.