Endometriosis Clinical Trial
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.
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.
After 4-6 months of the operation all the patients come to outpatient clinic visit to Turku
University Hospital's women's clinic. Before this visit they fill in the specific electric
questionnaire for the control visit. In this form they are asked for example how well they
have recovered from the operation and how their symptoms have developed. They also fill in
the EHP-30- and FSFI-forms. The endometrial and blood and urine samples are collected during
this visit. After this all patients will receive an annual follow up form electrically 1, 2
and 3 years after the operation in which they are asked about later recovery, symptoms and
possible pregnancies and the patients will also fill in the EHP-30- and FSFI-forms.
The information from the questionnaires is encoded so that an individual patient cannot be
identified. The questionnaires and the register collected from them will be stored in Turku
University Hospital at least until the study has ended.
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Observational Model: Case Control, Time Perspective: Prospective
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