Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial
Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial
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DOI：
10.1016/j.fertnstert.2004.03.046
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发表时间：
2004-10-01
影响因子：
6.7
通讯作者：
Garry, R
中科院分区：
文献类型：
--
作者：
Abbott, J;Hawe, J;Garry, R
目的：研究腹腔镜手术与安慰剂手术对子宫内膜异位症各期患者疼痛和生活质量的影响。设计：一项随机、盲法、交叉研究。设置：一家地区综合医院的三级转诊单位。患者：39名经组织学证实的子宫内膜异位症患者完成了为期12个月的研究。干预措施：妇女被随机分配到最初接受诊断性手术（延迟手术组）或完全切除手术（立即手术组）。6个月后，重复腹腔镜检查，去除任何病理present.Main结果Measure（S）：终点是视觉模拟疼痛评分，有效的生活质量工具（EQ-5D和SF-12），和性活动问卷评分从基线值的变化。结果：39名按照方案进行手术的妇女中，切除手术后症状改善的人数明显多于安慰剂组：20人中有16人（80%）比19人中有6人（32%）;卡方2（1）= 9.3。切除手术后6个月，生活质量的其他方面也有显著改善，但安慰剂治疗后没有改善。在第二次手术时，45%的病例中仅进行了初步诊断程序的女性表现出疾病进展，33%的病例中疾病保持静止，22%的病例中疾病有所改善。20%的病例报告对手术无反应。结论：腹腔镜子宫内膜异位症切除术在减轻疼痛和改善生活质量方面比安慰剂更有效。手术与30%的安慰剂反应率相关，这与疾病的严重程度无关。大约20%的妇女没有报告手术后子宫内膜异位症的改善。(C)2004年，美国生殖医学会。
Objective: To examine the effect on pain and quality of life for women with all stages of endometriosis undergoing laparoscopic surgery compared with placebo surgery.Design: A randomized, blinded, crossover study.Setting: A tertiary referral unit in a district general hospital.Patient(s): Thirty-nine women with histologically proven endometriosis completed the 12-month study.Intervention(s): Women were randomized to receive initially either a diagnostic procedure (the delayed surgical group) or full excisional surgery (the immediate surgery group). After 6 months, repeat laparoscopy was performed, with removal of any pathology present.Main Outcome Measure(s): The end points were changes from baseline values of visual analogue pain scores, validated quality-of-life instruments (EQ-5D and SF-12), and sexual activity questionnaire scores. Patients and assessors of outcomes were blinded to the treatment-group assignment.Result(s): Significantly more of the 39 women operated on according to protocol reported symptomatic improvement after excisional surgery than after placebo: 16 of 20 (80%) vs. 6 of 19 (32%); chi(2)(1) = 9.3. Other aspects of quality of life were also significantly improved 6 months after excisional surgery but not after placebo. Progression of disease at second surgery was demonstrated for women having only an initial diagnostic procedure in 45% of cases, with disease remaining static in 33% and improving in 22% of cases. Nonresponsiveness to surgery was reported in 20% of cases.Conclusion(s): Laparoscopic excision of endometriosis is more effective than placebo at reducing pain and improving quality of life. Surgery is associated with a 30% placebo response rate that is not dependent on severity of disease. Approximately 20% of women do not report an improvement after surgery for endometriosis. (C) 2004 by American Society for Reproductive Medicine.