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Operative Treatment of Endometriosis Patients in Turku University Hospital (ProEndo)

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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
Sponsor:
Information provided by (Responsible Party):
Carita Edgren, Turku University Hospital

Tracking Information
First Submitted Date February 19, 2013
First Posted Date May 8, 2013
Last Update Posted Date May 8, 2013
Study Start Date January 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2013)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 3, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Operative Treatment of Endometriosis Patients in Turku University Hospital
Official Title Not Provided
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood and urine samples. Peritoneal fluid, helthy peritoneum, endometriosis tissue and endometrium samples.
Sampling Method Probability Sample
Study Population Endometriosis patients to be operated in Turku university hospital 2013-2015. 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.
Condition Endometriosis
Intervention Not Provided
Study Groups/Cohorts
  • Endometriosis patients
    Endometriosis patients to be operated in Turku university hospital 2013-2015
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 3, 2013)
600
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Endometriosis
  • Adnexal finding
  • Laparoscopic sterilization

Exclusion Criteria:

  • Pregnancy
  • Acute infection
  • Hemoperitoneum
  • Suspicion of a malignancy
Sex/Gender
Sexes Eligible for Study: Female
Ages up to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01849354
Other Study ID Numbers T17/2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carita Edgren, Turku University Hospital
Study Sponsor Turku University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Turku University Hospital
Verification Date May 2013