A randomized prospective trial of rigid and flexible hysteroscopy in an outpatient setting

Andrew J. Baxter, Barbara Beck, Kevin Phillips
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引用次数: 18

Abstract

Objective To compare flexible and rigid hysteroscopy in an outpatient hysteroscopy clinic.

Design A randomized, single-blinded prospective study.

Setting A one-stop, outpatient hysteroscopy clinic in a district general hospital.

Subjects 96 women referred to the clinic with abnormal uterine bleeding.

Main outcome measures Patient pain scores, local anaesthetic usage, need for cervical dilation, quality of view, correlation of clinical and histological findings, duration of procedure, operator's assessment of the ease of the procedure.

Results Data from 83 women were analysed; three declined to enter the study, one failed to complete the pain scores and nine also had an operative hysteroscopy. Immediate median pain scores were statistically lower in the flexible hysteroscopy group, 1.2 vs. 3.6 (P = 0.001). The difference persisted 30 min after the procedure (0.4 vs. 1.1, P = 0.031). Pain experienced with endometrial biopsy was similar in the two groups (2.5 vs. 3.0, P = 0.16). There were no statistical differences between the two study arms with regard to procedure duration, quality of view, need for cervical dilation, anaesthetic usage or operator assessment of the ease of the procedure. There was agreement in clinical and histological diagnoses in all cases. The operators’ assessment of patients’ pain level correlated highly with patient pain scores. There were no statistically significant differences in any end-point between the two operators.

Conclusion Flexible hysteroscopy is associated with lower levels of patient discomfort than rigid hysteroscopy. Other study variables were comparable for the two types of hysteroscopy.

刚性和柔性宫腔镜在门诊的随机前瞻性试验
目的比较柔性宫腔镜与刚性宫腔镜在门诊宫腔镜检查中的应用。设计一项随机、单盲的前瞻性研究。在某地区综合医院设立一站式宫腔镜门诊。研究对象96名因子宫异常出血就诊的女性。主要观察指标:患者疼痛评分、局部麻醉的使用、宫颈扩张的需要、观察质量、临床和组织学表现的相关性、手术持续时间、手术操作者对手术难易程度的评价。结果分析了83名妇女的资料;其中3人拒绝参加研究,1人未能完成疼痛评分,9人也进行了手术宫腔镜检查。软性宫腔镜组即刻中位疼痛评分较低,分别为1.2比3.6 (P = 0.001)。手术后30分钟差异持续(0.4 vs 1.1, P = 0.031)。两组子宫内膜活检时的疼痛相似(2.5 vs. 3.0, P = 0.16)。在手术时间、观察质量、宫颈扩张的需要、麻醉剂的使用或操作者对手术难易程度的评估方面,两个研究组之间没有统计学差异。所有病例的临床和组织学诊断一致。操作者对患者疼痛程度的评估与患者疼痛评分高度相关。两组患者在任何终点均无统计学差异。结论软性宫腔镜与刚性宫腔镜相比,患者不适程度较低。两种宫腔镜的其他研究变量具有可比性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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