METHODS: The prospective open-label randomized controlled trial recruited women aged 22-55 with histologically confirmed Cervical Intraepithelial Neoplasia (CIN) 2 and 3 lesions. Participants were randomly allocated to either thermal ablation or LEEP. All cases were followed up with a Pap smear at three- and six-months post treatment. Sexual health assessments were conducted using a questionnaire at baseline and 3 months post-procedure. Secondary outcome measures included comparison of acceptability, pain, and side effects between the two treatment measures.
RESULTS: Out of 1356 screened cases, 60 were included in the study and randomized in two groups. The groups had similar baseline characteristics. Duration of LEEP was longer than thermal ablation (25.33 vs. 20.67 minutes), with higher pain reported 10 minutes post-procedure in the LEEP group. Three months post-procedure, both groups showed comparable acceptability and symptom relief. Sexual function parameters significantly improved in the thermal ablation group compared to LEEP, including satisfaction, desire, lubrication, flexibility, and ability to reach climax.
CONCLUSIONS: LEEP and thermal ablation are effective treatments for CIN with similar efficacy at 6 months. Thermal ablation demonstrated advantages in procedure time and post-procedural pain but exhibited varying effects on sexual function, improving satisfaction and desire. In contrast, LEEP showed a decrease in satisfaction and potential alterations in lubrication and flexibility. Larger-sample, longer-term studies are recommended for further insights.
方法:前瞻性开放标签随机对照试验招募了22-55岁经组织学证实的宫颈上皮内瘤变(CIN)2和3病变的女性。参与者被随机分配到热消融或LEEP。所有病例均在治疗后3个月和6个月进行巴氏涂片随访。在基线和术后3个月使用问卷进行性健康评估。次要结果指标包括可接受性比较,疼痛,两种治疗措施之间的副作用。
结果:在1356个筛查病例中,60人被纳入研究,随机分为两组。两组具有相似的基线特征。LEEP的持续时间长于热消融(25.33vs.20.67分钟),LEEP组术后10分钟疼痛较高。手术后三个月,两组均表现出相当的可接受性和症状缓解.与LEEP相比,热消融组的性功能参数明显改善,包括满意度,欲望,润滑,灵活性,和到达高潮的能力。
结论:LEEP和热消融是CIN的有效治疗方法,6个月时疗效相似。热消融在手术时间和术后疼痛方面表现出优势,但对性功能有不同的影响。提高满意度和欲望。相比之下,LEEP显示满意度下降,润滑和灵活性可能发生变化。较大的样本,建议进行长期研究以获得进一步的见解。