Incidence of Deeply Infiltrating Endometriosis in Surgically Treated Endometriosis Patients and Long-term Results of Surgical Treatment in Terms of Pain, Quality of Life and Sexual Functioning
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Endometriosis related pain symptoms before, and one year after the endometriosis surgery
研究概览
简要总结
The aim of this study is to examine the incidence of deeply infiltrating endometriotic lesions among surgically treated endometriosis patients, and examine the impact of endometriosis, and its surgical treatment, on severity of pain symptoms, quality of life, and sexual functioning.
详细描述
Patients scheduled for operation on suspected endometriosis in two study hospitals specialized in the surgical treatment of endometriosis between January 2005 - December 2007 (Päijät-Häme Central Hospital) and January 2008 - December 2008 (Helsinki University Hospital) were enrolled to the study. The diagnosis of endometriosis was histologically verified for all patients. Background data was collected from patients' age, body mass index, previous deliveries, previous endometriosis surgery, and current hormonal treatment for endometriosis.
From the beginning of January 2006 patients also completed preoperative questionnaires considering visual analogue scales (VAS) for pain symptoms (dysmenorrhea, deep dyspareunia, pain with urination and defecation, chronic pelvic pain, pain with ovulation), functional bowel and urinary symptoms, and 15D Quality of Life questionnaire, McCoy sexual functioning questionnaire, EHP-5 Short Form Endometriosis Profile questionnaire. Same questionnaires will also be completed six months, one year, two years, four years, and six years after the endometriosis operation. Follow-up questionnaires also contain questions concerning complications related to surgery, endometriosis recurrence, pregnancies, and infertility treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Finnish speaking patients scheduled for operation on suspected endometriosis
排除标准
- •Non-Finnish speaking patients
- •Previous hysterectomy.
- •Previous bilateral salpingo-oophorectomy
- •Any cancer
- •Chronic inflammatory bowel or bladder disease
- •Diabetes treated with insulin
- •Rheumatoid arthritis.
结局指标
主要结局
Endometriosis related pain symptoms before, and one year after the endometriosis surgery
时间窗: 12 months
Endometriosis related pain symptoms (dysmenorrhea, deep dyspareunia, pain with urination and defecation, chronic pelvic pain, pain with ovulation) assessed with visual analogue scales (VAS) and measured before, six months and one year after the surgery.
The incidence of deeply infiltrating lesions among surgically treated endometriosis patients.
时间窗: 3 years
The incidence of deeply infiltrating endometriosis among consecutive patients operated on suspected endometriosis between January 2005- December 2007
Quality of life before, and one year after the endometriosis surgery
时间窗: one year
Quality of life assessed with 15D Quality of Life questionnaire and EHP-5 Short Form Endometriosis Profile questionnaire before the operation and, one year after the surgery.
Sexual functioning of endometriosis patients before, and one year after the surgery
时间窗: one year
Sexual functioning measured with McCoy sexual functioning questionnaire before and one year after the surgery.
Complication related to surgical treatment of deeply infiltrating endometriosis with one year postoperative follow-up
时间窗: one year
Prospective monitoring of intraoperative complications, complications during the hospital stay, and mailed questionnaires six months, and one year after the endometriosis operation containing questions concerning complications related to surgery.
次要结局
- Recurrence of endometriosis after surgical treatment(six years)
研究者
Marjaleena Setala
M.D.
PaijatHame Central Hospital