Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Pelvic pain measured using NRS
研究概览
简要总结
The trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. Data will also be gathered on quality of life and neuropathic pain. Patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial tissue and 3) waiting list control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years) with suspected peritoneal endometriosis undergoing elective surgery for pain relief
- •Pain intensity ≥ 5 on Numeric Rating Scale (NRS) in the four weeks prior to giving consent
排除标准
- •Other known conditions/diseases that may cause pelvic pain
- •Diagnosed personality disorder, schizophrenia or treatment with anti-psychotics
- •Planned pregnancy during study period
- •Women who cannot read or speak Danish
研究组 & 干预措施
Active Surgery
干预措施: Medical treatment-as-usual (Other)
Diagnostic Surgery
干预措施: Laparoscopy without excision (Other)
Diagnostic Surgery
干预措施: Medical treatment-as-usual (Other)
No-surgery control
干预措施: Medical treatment-as-usual (Other)
Active Surgery
干预措施: Laparoscopy with excision (Other)
结局指标
主要结局
Pelvic pain measured using NRS
时间窗: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Pelvic pain intensity (sensory) and unpleasantness (affective) will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly.
次要结局
- Work ability measured using "Work Ability Index"(Change from pre-randomization to 1, 3 and 6 months post-randomization.)
- Neuropathic pain symptoms (assessed) measured using quantitative sensory testing(Change from pre-randomization to 6 months post-randomization.)
- Neuropathic pain symptoms (patient-reported) measured using painDETECT(Change from pre-randomization to 1, 3 and 6 months post-randomization.)
- Health-related Quality of Life measured using Endometriosis Health Profile-30(Change from pre-randomization to 1, 3 and 6 months post-randomization.)
- Pain frequency measured using weekly count(Change from pre-randomization to 1, 3 and 6 months post-randomization.)
- Worst pelvic pain measured using NRS(Change from pre-randomization to 1, 3 and 6 months post-randomization.)