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

• Conditions: Endometriosis
• Interventions: Procedure: Endometriosis surgery

• Registration Number: NCT01105897
• Lead Sponsor: PaijatHame Central Hospital

Brief 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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-16
• Study First Posted: 2010-04-19
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-30
• Last Update Posted: 2012-08-31
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 201

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgically treated endometriosis patients	Endometriosis surgery	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).

Primary Outcome Measures

Name	Time	Method
Endometriosis related pain symptoms before, and one year after the endometriosis surgery	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.	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence of endometriosis after surgical treatment	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

Trial Locations

Locations (1)

Päijät-Häme Central Hospital; 🇫🇮 Lahti, Finland