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
|Condition or disease||Intervention/treatment|
|Endometriosis||Procedure: Endometriosis surgery|
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 Type :||Observational|
|Actual Enrollment :||201 participants|
|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|
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
- 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.
- 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
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
|Päijät-Häme Central Hospital|
|Lahti, Finland, 15850|
|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|