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临床试验/NCT01849354
NCT01849354Unknown不适用

Operative Treatment of Endometriosis Patients in Turku University Hospital

Turku University Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
The quality of life before and after the endometriosis surgery

研究概览

简要总结

The women's clinic at Turku University Hospital has also since year 2000 accomplished and systematically increased advanced surgical treatment for the endometriosis patients with difficult disease. The aim is to centralize endometriosis treatment in the hospital district and by doing that be able to offer exact diagnosis, advanced surgical treatment and infertility treatment for every patient in the hospital area. The main purpose of this study is to find out how the operative treatment of endometriosis patients in Turku University Hospital is functioning and to see how the quality of life of these patients is before and after the surgery. Furthermore, the structure of the endometriosis patients' endometrium and the different markers of blood and urine are studied.

详细描述

This prospective study is performed with the women's clinic in Turku University Hospital.

The aim is to get every patient, who is operated because of endometriosis in Turku University Hospital, to participate on the study. The patients are recruited on the basis of the referral letters, which have been sent to the endometriosis outpatient clinic. Before the visit to the outpatient clinic they are sent an electric form in which it is told about the study and the samples to be collected and from the voluntariness of the participation and privacy protection. The patients fill in the electric anamnesis form, which is gone through with the outpatient clinic visit. With the outpatient clinic visit the patients sign a consent form together with the doctor. After having agreed to the study the patients will fill an electric questionnaire about quality of life of endometriosis patient (EHP-30) and a questionnaire about their sexual satisfaction (FSFI) before the operation. The electric forms are made on the Webropol-program. In the electric forms the patient information is encoded so that an individual patient cannot be identified.

The control group consists of patients who will be operated because of an adnexal finding other than endometriosis, for example ovarian cyst. Also patients with laparoscopic sterilization will be recruited to the control group. The patients who might be suitable, are contacted by telephone call. The main points of the study are explained to them and they are asked to participate in the study. The control patients fill in the same electric forms before the operation as the endometriosis patients do and doctor discusses with them before they agree to the study. The exclusion criterions are acute infection, pregnancy, hemoperitoneum, suspicion of a malignancy or incidentally found endometriosis.

The findings during the operation of endometriosis patients and the procedures that have been done are documented on the specific forms made for this purpose (Oper1, -2 ja -3-forms) and the prognostic form for future fertility (Endometriosis Fertility Index) is filled. On the morning of the operation day the urine and blood samples are taken and the samples from endometrium, peritoneum and peritoneal fluid as well as the endometriotic tissue are collected during the operation.

Blood and urine samples are taken also from the control patients on the morning of the operation day. During the operation the samples from peritoneum, peritoneal fluid and endometriotic tissue are collected.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Endometriosis
  • Adnexal finding
  • Laparoscopic sterilization

排除标准

  • Pregnancy
  • Acute infection
  • Hemoperitoneum
  • Suspicion of a malignancy

结局指标

主要结局

The quality of life before and after the endometriosis surgery

时间窗: 3 years

Quality of life is assessed with EHP-30 questionnaire before and 6 months, 1, 2 and 3 years after the endometriosis surgery

Endometriosis related pain symptoms before and after the endometriosis surgery

时间窗: 3 years

Endometriosis related pain symptoms are collected from the operativelly treated endometriosis patients by a questionnaire 6 months, 1, 2 and 3 years after the surgery by using NRS-scale.

Sexual functioning before and after endometriosis surgery

时间窗: 3 years

Sexual functioning is measured by using FSFI (Female Sexual Function Index)-form before, 6 months, 1, 2 and 3 years after endometriosis surgery.

次要结局

  • Novel diagnostic markers for endometriosis(3 years)

研究者

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

Carita Edgren

MD

Turku University Hospital

研究点 (1)

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