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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: Endometriosis surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgically treated endometriosis patients<br>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<br>* Complete surgical excision of all visible endometriosis by multidisciplinary approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, deep endometriosis, surgery, laparoscopy, chronic pain, quality of life, sexual function, complications, recurrence