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EndometriosisNCT01105897

Prospective Study of the Outcomes of the Surgical Treatment of Deeply Infiltrating Endometriosis

An observational study of Endometriosis, run by PaijatHame Central 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 The sponsor has not verified this record for over two years, so it may be out of date.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 aim of this study is to examine the incidence of deeply infiltrating endometriotic lesions among surgically treated endometriosis patients, and examine the impact of endometriosis, and its surgical treatment, on severity of pain symptoms, quality of life, and sexual functioning. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Endometriosis
What is being tested?
Endometriosis surgery
Type of treatment
Surgery or procedure
How many people
201 participants
Where
1 siteFinland
Study dates
Jan 2005to Dec 2014
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 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women scheduled for operation on suspected endometriosis in two study hospitals between January 2005 - December 2007 (Päijät-Häme Central Hospital) and January 2008 - December 2008 (Helsinki University Hospital).

Who may be able to join

  • Finnish speaking patients scheduled for operation on suspected endometriosis

Who cannot join

  • Non-Finnish speaking patients
  • Previous hysterectomy.
  • Previous bilateral salpingo-oophorectomy
  • Any cancer
  • Chronic inflammatory bowel or bladder disease
  • Diabetes treated with insulin
  • Rheumatoid arthritis.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Päijät-Häme Central Hospital

    Lahti, Lahti, 15850

Other trials in Finland

About this study

Official title: Incidence of Deeply Infiltrating Endometriosis in Surgically Treated Endometriosis Patients and Long-term Results of Surgical Treatment in Terms of Pain, Quality of Life and Sexual Functioning

The aim of this study is to examine the incidence of deeply infiltrating endometriotic lesions among surgically treated endometriosis patients, and examine the impact of endometriosis, and its surgical treatment, on severity of pain symptoms, quality of life, and sexual functioning.

Read the detailed description

Patients scheduled for operation on suspected endometriosis in two study hospitals specialized in the surgical treatment of endometriosis between January 2005 - December 2007 (Päijät-Häme Central Hospital) and January 2008 - December 2008 (Helsinki University Hospital) were enrolled to the study. The diagnosis of endometriosis was histologically verified for all patients. Background data was collected from patients' age, body mass index, previous deliveries, previous endometriosis surgery, and current hormonal treatment for endometriosis.

From the beginning of January 2006 patients also completed preoperative questionnaires considering visual analogue scales (VAS) for pain symptoms (dysmenorrhea, deep dyspareunia, pain with urination and defecation, chronic pelvic pain, pain with ovulation), functional bowel and urinary symptoms, and 15D Quality of Life questionnaire, McCoy sexual functioning questionnaire, EHP-5 Short Form Endometriosis Profile questionnaire. Same questionnaires will also be completed six months, one year, two years, four years, and six years after the endometriosis operation. Follow-up questionnaires also contain questions concerning complications related to surgery, endometriosis recurrence, pregnancies, and infertility treatments.

Conditions
Endometriosis
Being tested
Endometriosis surgery
Keywords
endometriosis, deep endometriosis, surgery, laparoscopy, chronic pain, quality of life, sexual function, complications, recurrence
Medical subject headings
Endometriosis, Chronic Pain, Recurrence

What participants receive

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

  • Endometriosis surgeryProcedure or surgery

    Complete surgical excision of all visible endometriosis by multidisciplinary approach

Study groups in NCT01105897
Study groupRoleWhat they receive
Surgically treated endometriosis patientsWomen scheduled for operation on suspected endometriosis in two study hospitals specialized in the surgical treatment of endometriosis between January 2005 - December 2007 (Päijät-Häme Central Hospital) and January 2008 - December 2008 (Helsinki University Hospital).
Receives: Procedure: Endometriosis surgery

What is being measured

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

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

    Endometriosis related pain symptoms (dysmenorrhea, deep dyspareunia, pain with urination and defecation, chronic pelvic pain, pain with ovulation) assessed with visual analogue scales (VAS) and measured before, six months and one year after the surgery.

    Measured: 12 months

  2. The incidence of deeply infiltrating lesions among surgically treated endometriosis patients.

    The incidence of deeply infiltrating endometriosis among consecutive patients operated on suspected endometriosis between January 2005- December 2007

    Measured: 3 years

  3. Quality of life before, and one year after the endometriosis surgery

    Quality of life assessed with 15D Quality of Life questionnaire and EHP-5 Short Form Endometriosis Profile questionnaire before the operation and, one year after the surgery.

    Measured: one year

  4. Sexual functioning of endometriosis patients before, and one year after the surgery

    Sexual functioning measured with McCoy sexual functioning questionnaire before and one year after the surgery.

    Measured: one year

  5. Complication related to surgical treatment of deeply infiltrating endometriosis with one year postoperative follow-up

    Prospective monitoring of intraoperative complications, complications during the hospital stay, and mailed questionnaires six months, and one year after the endometriosis operation containing questions concerning complications related to surgery.

    Measured: one year

Secondary outcomes (1)

  1. Recurrence of endometriosis after surgical treatment

    Mailed questionnaires six months, one year, two years, four years, and six years after the surgical treatment of endometriosis containing questions about the recurrence of pain symptoms and about further endometriosis operations

    Measured: six years

Timeline

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

  1. First posted19 Apr 2010 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2014 (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
Cohort
Time perspective
Prospective
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01105897
Sponsor's protocol ID
ETLQ62/81
Status last verified
Aug 2012
First submitted
15 Apr 2010
Last updated
31 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • Setälä M, Härkki P, Suvitie P, Fraser J, Jalkanen J, Kössi J, Perheentupa A, Mäkinen J. Is the presence of endometrioma always associated with more severe disease? Gynecol Surg, 2011 Jan. Epub ahead of print.

  • Huhtinen K, Suvitie P, Hiissa J, Junnila J, Huvila J, Kujari H, Setala M, Harkki P, Jalkanen J, Fraser J, Makinen J, Auranen A, Poutanen M, Perheentupa A. Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts. Br J Cancer. 2009 Apr 21;100(8):1315-9. doi: 10.1038/sj.bjc.6605011. Epub 2009 Mar 31.

    PubMed 19337252

  • Kossi J, Setala M, Enholm B, Luostarinen M. The early outcome of laparoscopic sigmoid and rectal resection for endometriosis. Colorectal Dis. 2010 Mar;12(3):232-5. doi: 10.1111/j.1463-1318.2009.01923.x. Epub 2009 Apr 27.

    PubMed 19438891

  • Setala M, Savolainen H, Kossi J, Ranta T, Makinen J. Deeply infiltrating disease in surgically treated endometriosis patients. Acta Obstet Gynecol Scand. 2011 May;90(5):468-72. doi: 10.1111/j.1600-0412.2011.01097.x. Epub 2011 Mar 29.

    PubMed 21314818

  • Setala M, Kossi J, Silventoinen S, Makinen J. The impact of deep disease on surgical treatment of endometriosis. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):289-93. doi: 10.1016/j.ejogrb.2011.04.046. Epub 2011 May 31.

    PubMed 21621895

  • Kossi J, Setala M, Makinen J, Harkki P, Luostarinen M. Quality of life and sexual function 1 year after laparoscopic rectosigmoid resection for endometriosis. Colorectal Dis. 2013 Jan;15(1):102-8. doi: 10.1111/j.1463-1318.2012.03111.x.

    PubMed 22642851

  • Setala M, Harkki P, Matomaki J, Makinen J, Kossi J. Sexual functioning, quality of life and pelvic pain 12 months after endometriosis surgery including vaginal resection. Acta Obstet Gynecol Scand. 2012 Jun;91(6):692-8. doi: 10.1111/j.1600-0412.2012.01394.x. Epub 2012 Apr 30.

    PubMed 22404128

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by PaijatHame Central 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 1 inclusion and 7 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 31 Aug 2012. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endometriosis related pain symptoms before, and one year after the endometriosis surgery (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01105897, which also lists 7 linked publications.

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 31 Aug 2012.

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