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

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ClinicalTrials.gov Identifier: NCT01105897

Recruitment Status : Unknown

Verified August 2012 by Marjaleena Setala, PaijatHame Central Hospital.
Recruitment status was: Active, not recruiting

First Posted : April 19, 2010

Last Update Posted : August 31, 2012

Sponsor:

Information provided by (Responsible Party):

Marjaleena Setala, PaijatHame Central Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Endometriosis	Procedure: Endometriosis surgery

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.

Study Design


Study Type :	Observational
Actual Enrollment :	201 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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
Study Start Date :	January 2005
Estimated Primary Completion Date :	December 2014
Estimated Study Completion Date :	December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Surgically treated endometriosis patients Women 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).	Procedure: Endometriosis surgery Complete surgical excision of all visible endometriosis by multidisciplinary approach

Outcome Measures

Primary Outcome Measures :

Endometriosis related pain symptoms before, and one year after the endometriosis surgery [ Time Frame: 12 months ]
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.
The incidence of deeply infiltrating lesions among surgically treated endometriosis patients. [ Time Frame: 3 years ]
The incidence of deeply infiltrating endometriosis among consecutive patients operated on suspected endometriosis between January 2005- December 2007
Quality of life before, and one year after the endometriosis surgery [ Time Frame: one year ]
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.
Sexual functioning of endometriosis patients before, and one year after the surgery [ Time Frame: one year ]
Sexual functioning measured with McCoy sexual functioning questionnaire before and one year after the surgery.
Complication related to surgical treatment of deeply infiltrating endometriosis with one year postoperative follow-up [ Time Frame: one year ]
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.

Secondary Outcome Measures :

Recurrence of endometriosis after surgical treatment [ Time Frame: six years ]
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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).

Criteria

Inclusion Criteria:

Finnish speaking patients scheduled for operation on suspected endometriosis

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

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): NCT01105897

Locations


Finland
Päijät-Häme Central Hospital
Lahti, Finland, 15850

Sponsors and Collaborators

PaijatHame Central Hospital

Investigators


Principal Investigator:	Marjaleena Setälä, MD	Päijänne Tavastia Central Hospital
Study Director:	Jyrki Kössi, MD, PhD	Päijänne Tavastia Central Hospital
Study Director:	Juha Mäkinen, Prof.	Turku University Hospital, Turku, Finland

More Information

Publications of Results:

Kössi J, Setälä 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.

Setälä M, Savolainen H, Kössi J, Ranta T, Mäkinen 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.

Setälä M, Kössi J, Silventoinen S, Mäkinen 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.

Kössi J, Setälä M, Mäkinen J, Härkki 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.

Setälä M, Härkki P, Matomäki J, Mäkinen J, Kössi 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.

Other 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, Setälä M, Härkki P, Jalkanen J, Fraser J, Mäkinen 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.


Responsible Party:	Marjaleena Setala, M.D., PaijatHame Central Hospital
ClinicalTrials.gov Identifier:	NCT01105897 History of Changes
Other Study ID Numbers:	ETLQ62/81
First Posted:	April 19, 2010 Key Record Dates
Last Update Posted:	August 31, 2012
Last Verified:	August 2012

Keywords provided by Marjaleena Setala, PaijatHame Central Hospital:


endometriosis deep endometriosis surgery laparoscopy chronic pain	quality of life sexual function complications recurrence

Additional relevant MeSH terms:


Endometriosis Genital Diseases, Female

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