Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01105897
Enrollment
201
Registered
2010-04-19
Start date
2005-01-31
Completion date
2014-12-31
Last updated
2012-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

endometriosis, deep endometriosis, surgery, laparoscopy, chronic pain, quality of life, sexual function, complications, recurrence

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.

Interventions

Complete surgical excision of all visible endometriosis by multidisciplinary approach

Sponsors

PaijatHame Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Endometriosis related pain symptoms before, and one year after the endometriosis surgery12 monthsEndometriosis 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 yearsThe 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 surgeryone yearQuality 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 surgeryone yearSexual 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-upone yearProspective 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

MeasureTime frameDescription
Recurrence of endometriosis after surgical treatmentsix yearsMailed 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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026