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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometriosis surgery | Procedure | Complete surgical excision of all visible endometriosis by multidisciplinary approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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 | 3 years |
| 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. | one year |
| 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. | one year |
| 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | six years |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Marjaleena Setälä, MD | Päijänne Tavastia Central Hospital | Principal Investigator |
| Jyrki Kössi, MD, PhD | Päijänne Tavastia Central Hospital | Study Director |
| Juha Mäkinen, Prof. | Turku University Hospital, Turku, Finland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Päijät-Häme Central Hospital | Lahti | Lahti | 15850 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 19337252 | Background | 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. | |
| 19438891 |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D059350 | Chronic Pain |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Result |
| 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. |
| 21314818 | Result | 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. |
| 21621895 | Result | 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. |
| 22642851 | Result | 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. |
| 22404128 | Result | 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. |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |