Overview

This trial is active, not recruiting.

Condition endometriosis
Treatment endometriosis surgery
Sponsor PaijatHame Central Hospital
Start date January 2005
End date December 2014
Trial size 201 participants
Trial identifier NCT01105897, ETLQ62/81

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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

Primary Outcomes

Measure
Endometriosis related pain symptoms before, and one year after the endometriosis surgery
time frame: 12 months
The incidence of deeply infiltrating lesions among surgically treated endometriosis patients.
time frame: 3 years
Quality of life before, and one year after the endometriosis surgery
time frame: one year
Sexual functioning of endometriosis patients before, and one year after the surgery
time frame: one year
Complication related to surgical treatment of deeply infiltrating endometriosis with one year postoperative follow-up
time frame: one year

Secondary Outcomes

Measure
Recurrence of endometriosis after surgical treatment
time frame: six years

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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.

Additional Information

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
Principal investigator Marjaleena Setälä, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by PaijatHame Central Hospital.