Prospective Study of the Outcomes of the Surgical Treatment of Deeply Infiltrating Endometriosis
NCT ID: NCT01105897
Last Updated: 2012-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
201 participants
OBSERVATIONAL
2005-01-31
2014-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
Endometriosis surgery
Complete surgical excision of all visible endometriosis by multidisciplinary approach
Interventions
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Endometriosis surgery
Complete surgical excision of all visible endometriosis by multidisciplinary approach
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous hysterectomy.
* Previous bilateral salpingo-oophorectomy
* Any cancer
* Chronic inflammatory bowel or bladder disease
* Diabetes treated with insulin
* Rheumatoid arthritis.
18 Years
65 Years
FEMALE
No
Sponsors
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PaijatHame Central Hospital
OTHER
Responsible Party
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Marjaleena Setala
M.D.
Principal Investigators
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Marjaleena Setälä, MD
Role: PRINCIPAL_INVESTIGATOR
Päijänne Tavastia Central Hospital
Jyrki Kössi, MD, PhD
Role: STUDY_DIRECTOR
Päijänne Tavastia Central Hospital
Juha Mäkinen, Prof.
Role: STUDY_DIRECTOR
Turku University Hospital, Turku, Finland
Locations
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Päijät-Häme Central Hospital
Lahti, Lahti, Finland
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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ETLQ62/81
Identifier Type: -
Identifier Source: org_study_id