NCT01105897

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 201 (actual)
• Sponsor: PaijatHame Central Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
PROCEDURE	Endometriosis surgery	Complete surgical excision of all visible endometriosis by multidisciplinary approach

Timeline

• Start date: 2005-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-04-19
• Last updated: 2012-08-31

Locations

1 site across 1 country: Finland