Yeung Patrick, Tu Frank, Bajzak Krisztina, Lamvu Georgine, Guzovsky Olga, Agnelli Rob, Peavey Mary, Winer Wendy, Albee Robert, Sinervo Ken
Department of Obstetrics, Gynecology & Women's Health, Saint Louis University, St. Louis, MO, USA.
JSLS. 2013 Jan-Mar;17(1):88-94. doi: 10.4293/108680812X13517013317833.
To serve as a pilot feasibility study for a randomized study of excision versus ablation in the treatment of endometriosis by (1) estimating the magnitude of change in symptoms after excision only at multiple referral centers and (2) determining the proportion of women willing to participate in a randomized trial.
We performed a multicenter prospective study of women undergoing excision for endometriosis (Canadian Task Force class II-3) at Duke University Center for Endometriosis Research & Treatment (currently the Saint Louis University Center for Endometriosis), Center for Endometriosis Care, Northshore University Health System, Memorial University (Canada), and Florida Hospital. The study comprised 100 female patients, aged 18 to 55 years, with endometriosis-suspected pelvic pain. The intervention was laparoscopic excision only of the abnormal peritoneum suspicious for endometriosis. The main outcome measures were quality of life, pelvic pain, dysmenorrhea, dyspareunia, and bowel and bladder symptoms.
The mean follow-up period was 8.5 months. Excision of endometriosis showed a significant reduction in all pain scores except bowel symptoms, as well as significant improvement in quality of life. Of the patients, 84% were willing to participate in a randomized study.
Quality of life is a needed primary outcome for any randomized study comparing excision versus ablation. A multicenter comparative trial is feasible, although quality assurance would have to be addressed. Patients were willing to be randomized even at surgical referral centers.
通过（1）在多个转诊中心仅评估切除术后症状的变化程度，以及（2）确定愿意参与随机试验的女性比例，为一项关于子宫内膜异位症治疗中切除术与消融术的随机研究开展一项试点可行性研究。
我们在杜克大学子宫内膜异位症研究与治疗中心（现为圣路易斯大学子宫内膜异位症中心）、子宫内膜异位症护理中心、北岸大学健康系统、加拿大纪念大学和佛罗里达医院，对接受子宫内膜异位症切除术的女性进行了一项多中心前瞻性研究（加拿大工作组II - 3级）。该研究纳入了100名年龄在18至55岁之间、疑似因子宫内膜异位症导致盆腔疼痛的女性患者。干预措施仅为腹腔镜切除可疑子宫内膜异位症的异常腹膜。主要结局指标包括生活质量、盆腔疼痛、痛经、性交困难以及肠道和膀胱症状。
平均随访期为8.5个月。子宫内膜异位症切除术显示，除肠道症状外，所有疼痛评分均显著降低，生活质量也有显著改善。其中84%的患者愿意参与随机研究。
生活质量是任何比较切除术与消融术的随机研究所需的主要结局指标。多中心比较试验是可行的，不过必须解决质量保证问题。即使在手术转诊中心，患者也愿意接受随机分组。
