Robotic Surgical Management of Endometriosis: Excision Versus Ablation With Argon Beam Coagulator (ABC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned to either ablation or excision of endometriosis. The investigators think that patients who have excision of endometriosis will have greater relief of pain.
详细描述
Patients with known endometriosis based on prior surgical pathology or suspected endometriosis based on symptomatology who plan on undergoing diagnostic laparoscopy will be offered enrollment in the study. They will complete preoperative pain assessments with the tools outlined above. At the time of diagnostic laparoscopy, patients found to have endometriosis will be staged according to the American Society of Reproductive Medicine guidelines. Patients with Stage 4 or deeply infiltrating endometriosis will be excluded from the study. At that point, the patients will be randomized in the operating room to either laparoscopic excision of endometriosis or laparoscopic ablation with the argon beam coagulator. Patients will be stratified according to the presence or absence of the Levonorgestrel-Intrauterine Device.
Pain assessments will be performed immediately postoperatively in the recovery area. Pain assessments will again be performed at 4 weeks, 6 months and 12 months. We will use the VAS pain scale and validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Endometriosis
- •Chronic Pelvic Pain
- •Stage 1-3 Endometriosis
- •Reproductive aged women
排除标准
- •Stage 4 Endometriosis
- •Deeply Infiltrating Endometriosis
- •Patients who decline surgical management of endometriosis
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 12 months
Patients will document their pain on a VAS.
次要结局
- Quality of Life and Pain Questionnaires(12 months)
研究者
Timothy A Deimling
Assistant Professor, Division of Obstetrics and Gynecology
Milton S. Hershey Medical Center
