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手术切除与消融治疗浅表子宫内膜异位症相关疼痛的随机对照试验。

Surgical Excision Versus Ablation for Superficial Endometriosis-Associated Pain: A Randomized Controlled Trial.

机构信息

Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecologic Surgery, Milton S. Hershey Medical Center, Penn State University, Hershey, Pennsylvania.

Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecologic Surgery, Milton S. Hershey Medical Center, Penn State University, Hershey, Pennsylvania.

出版信息

J Minim Invasive Gynecol. 2019 Jan;26(1):71-77. doi: 10.1016/j.jmig.2018.03.023. Epub 2018 Mar 30.

Abstract

STUDY OBJECTIVE

To compare surgical excision and ablation of endometriosis for treatment of chronic pelvic pain.

DESIGN

Randomized clinical trial with 12-month follow-up (Canadian Task Force classification I).

SETTING

Single academic tertiary care hospital.

PATIENTS

Women with minimal to mild endometriosis undergoing laparoscopy.

INTERVENTIONS

Excision or ablation of superficial endometriosis at the time of robot-assisted laparoscopy.

MEASUREMENTS AND MAIN RESULTS

Primary outcome was visual analog scale (VAS) scoring at baseline and 6 and 12 months for menstrual pain, nonmenstrual pain, dyspareunia, and dyschezia. Secondary outcomes included survey results at baseline and 6 and 12 months from the Short Form Health Survey, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, and the International Pelvic Pain Assessment. From December 2013 to October 2014, 73 patients were randomized intraoperatively to excision (n = 37) or ablation (n = 36) of endometriosis. Patients were followed at 6 and 12 months to evaluate the above outcomes. After ablation of endometriosis, dyspareunia (VAS scores) improved at 6 months (mean change [MC], -14.07; 95% confidence interval [CI], -25.93 to -2.21; p = .02), but improvement was not maintained at 12 months. Dysmenorrhea improved at 6 months (MC, -26.99; 95% CI, -41.48 to -12.50; p < .001) and 12 months (MC, -24.15; 95% CI, 39.62 to -8.68; p = .003) with ablation. No significant changes were seen in VAS scores after excision at 6 or 12 months. When comparing ablation and excision, the only significant difference was a change in dyspareunia at 6 months (MC, -22.96; 95% CI, -39.06 to -6.86; p = .01).

CONCLUSION

Treatment with ablation improved dysmenorrhea at 6 and 12 months and improved dyspareunia at 6 months as compared with preoperative data. However, only dyspareunia demonstrated a significant difference between ablation and excision. Excision and ablation showed similar effectiveness for the treatment of pain associated with superficial endometriosis, with ablation showing more significant individual changes. Careful patient counseling regarding expectations of surgical intervention is vital in the management of endometriosis.

摘要

研究目的

比较子宫内膜异位症的手术切除和消融治疗慢性盆腔疼痛。

设计

有 12 个月随访的随机临床试验(加拿大任务组分类 I)。

地点

单家学术性三级保健医院。

患者

接受机器人辅助腹腔镜检查的轻度至轻度子宫内膜异位症患者。

干预措施

在机器人辅助腹腔镜检查时切除或消融表浅子宫内膜异位症。

测量和主要结果

主要结果是基线和 6 个月及 12 个月时月经痛、非经期疼痛、性交痛和排便困难的视觉模拟评分(VAS)。次要结果包括基线和 6 个月及 12 个月时从简明健康调查量表、盆腔器官脱垂/尿失禁性功能问卷和国际盆腔疼痛评估获得的调查结果。2013 年 12 月至 2014 年 10 月,73 例患者在术中随机分为切除组(n=37)或消融组(n=36)治疗子宫内膜异位症。患者在 6 个月和 12 个月时接受随访以评估上述结果。在消融子宫内膜异位症后,性交痛(VAS 评分)在 6 个月时得到改善(平均变化[MC],-14.07;95%置信区间[CI],-25.93 至-2.21;p=0.02),但在 12 个月时未得到维持。痛经在 6 个月(MC,-26.99;95%CI,-41.48 至-12.50;p<0.001)和 12 个月(MC,-24.15;95%CI,39.62 至-8.68;p=0.003)时得到改善。切除后在 6 个月或 12 个月时 VAS 评分无明显变化。消融与切除相比,仅在 6 个月时性交痛有显著变化(MC,-22.96;95%CI,-39.06 至-6.86;p=0.01)。

结论

与术前数据相比,消融治疗可改善 6 个月和 12 个月时的痛经,并改善 6 个月时的性交痛。然而,只有性交痛在消融和切除之间显示出显著差异。切除和消融对表浅子宫内膜异位症相关疼痛的治疗效果相似,消融显示出更显著的个体变化。在子宫内膜异位症的管理中,对手术干预的期望进行仔细的患者咨询至关重要。

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