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临床试验/NCT02350790
NCT02350790已完成不适用

Robotic Surgical Management of Endometriosis: Excision Versus Ablation With Argon Beam Coagulator (ABC)

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2013年12月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy A Deimling

Assistant Professor, Division of Obstetrics and Gynecology

Milton S. Hershey Medical Center

研究点 (2)

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