Operative Treatment of Endometriosis Patients in Turku University Hospital (ProEndo)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01849354|
Recruitment Status : Unknown
Verified May 2013 by Carita Edgren, Turku University Hospital.
Recruitment status was: Recruiting
First Posted : May 8, 2013
Last Update Posted : May 8, 2013
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||600 participants|
|Target Follow-Up Duration:||3 Years|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2015|
Endometriosis patients to be operated in Turku university hospital 2013-2015
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.
- Endometriosis related pain symptoms before and after the endometriosis surgery [ Time Frame: 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.
- The quality of life before and after the endometriosis surgery [ Time Frame: 3 years ]Quality of life is assessed with EHP-30 questionnaire before and 6 months, 1, 2 and 3 years after the endometriosis surgery
- Sexual functioning before and after endometriosis surgery [ Time Frame: 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.
- Novel diagnostic markers for endometriosis [ Time Frame: 3 years ]Samples of blood, urine, endometrium and endometriosis tissue are collected during the operation and analyzed to find novel diagnostic markers for endometriosis.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849354
|Contact: Carita Edgrenfirstname.lastname@example.org|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20100|
|Contact: Carita C Edgren email@example.com|