NCT01849354

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

Enrollment Period

2.9 years

First QC Date

February 19, 2013

Last Update Submit

May 3, 2013

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    3 years

  • 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

    3 years

  • 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.

    3 years

Secondary Outcomes (1)

  • Novel diagnostic markers for endometriosis

    3 years

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Endometriosis
  • Adnexal finding
  • Laparoscopic sterilization

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20100, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples. Peritoneal fluid, helthy peritoneum, endometriosis tissue and endometrium samples.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Carita Edgren

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2013

First Posted

May 8, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Last Updated

May 8, 2013

Record last verified: 2013-05

Locations