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

August 30, 2012 updated by: Marjaleena Setala, PaijatHame Central Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Lahti, Finland, 15850
        • Päijät-Häme Central hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women scheduled for operation on suspected endometriosis in two study hospitals between January 2005 - December 2007 (Päijät-Häme Central Hospital) and January 2008 - December 2008 (Helsinki University Hospital).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgically treated endometriosis patients
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
Complete surgical excision of all visible endometriosis by multidisciplinary approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometriosis related pain symptoms before, and one year after the endometriosis surgery
Time Frame: 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.
12 months
The incidence of deeply infiltrating lesions among surgically treated endometriosis patients.
Time Frame: 3 years
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
Time Frame: 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.
one year
Sexual functioning of endometriosis patients before, and one year after the surgery
Time Frame: one year
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
Time Frame: 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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of endometriosis after surgical treatment
Time Frame: 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
six years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PaijatHame Central Hospital

Investigators

  • Principal Investigator: Marjaleena Setälä, MD, Päijänne Tavastia Central Hospital
  • Study Director: Jyrki Kössi, MD, PhD, Päijänne Tavastia Central Hospital
  • Study Director: Juha Mäkinen, Prof., Turku University Hospital, Turku, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 16, 2010

First Posted (ESTIMATE)

April 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETLQ62/81

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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