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EndometriosisProEndoNCT01849354

Operative Treatment of Endometriosis Patients in Turku University Hospital

An observational study of Endometriosis, run by Turku University Hospital at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 50 years, women only
Conditions the study is for
Endometriosis
How many people
600 participants
Where
1 siteFinland
Study dates
Jan 2013to Dec 2015
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 50 years
  • Women only
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • Endometriosis
  • Adnexal finding
  • Laparoscopic sterilization

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Carita Edgren contact

carita.edgren@tyks.fi

Finland1 site, 1 recruiting
  • Turku University Hospital

    Turku, 20100

    Carita C Edgren, carita.edgren@tyks.fi

    Recruiting

Other trials in Finland

About this study

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.

Read the 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
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01849354
Study groupRoleWhat they receive
Endometriosis patientsEndometriosis patients to be operated in Turku university hospital 2013-2015
Control patientsPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endometriosis related pain symptoms before and after the endometriosis surgery

    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.

    Measured: 3 years

  2. The quality of life before and after the endometriosis surgery

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

    Measured: 3 years

  3. Sexual functioning before and after endometriosis surgery

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

    Measured: 3 years

Secondary outcomes (1)
  1. Novel diagnostic markers for endometriosis

    Samples of blood, urine, endometrium and endometriosis tissue are collected during the operation and analyzed to find novel diagnostic markers for endometriosis.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
600 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT01849354
Sponsor's protocol ID
T17/2013
Acronym
ProEndo
Status last verified
May 2013
First submitted
19 Feb 2013
Last updated
8 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by Turku University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carita Edgren (carita.edgren@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endometriosis related pain symptoms before and after the endometriosis surgery (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.

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