Operative Treatment of Endometriosis Patients in Turku University Hospital

NCT ID: NCT01849354

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Endometriosis patients

Endometriosis patients to be operated in Turku university hospital 2013-2015

No interventions assigned to this group

Control patients

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Endometriosis
• Adnexal finding
• Laparoscopic sterilization

Exclusion Criteria

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

• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Carita Edgren

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Turku University Hospital

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Carita Edgren

Role: CONTACT

carita.edgren@tyks.fi

Facility Contacts

Carita C Edgren

Role: primary

carita.edgren@tyks.fi

Other Identifiers

T17/2013

Identifier Type: -

Identifier Source: org_study_id