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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marjaleena Setala, PaijatHame Central Hospital
ClinicalTrials.gov Identifier:
NCT01105897
First received: April 15, 2010
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Endometriosis
Procedure: Endometriosis surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by PaijatHame Central Hospital:

Primary Outcome Measures:
  • Endometriosis related pain symptoms before, and one year after the endometriosis surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Recurrence of endometriosis after surgical treatment [ Time Frame: six years ] [ Designated as safety issue: No ]
    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


Enrollment: 201
Study Start Date: January 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105897

Locations
Finland
Päijät-Häme Central Hospital
Lahti, Finland, 15850
Sponsors and Collaborators
PaijatHame Central Hospital
Investigators
Principal Investigator: Marjaleena Setälä, MD Päijät-Häme Central Hospital, Lahti, Finland
Study Director: Jyrki Kössi, MD, PhD Päijät-Häme Central Hospital, Lahti, Finland
Study Director: Juha Mäkinen, Prof. Turku University Hospital, Turku, Finland
  More Information

Publications:
Responsible Party: Marjaleena Setala, M.D., PaijatHame Central Hospital
ClinicalTrials.gov Identifier: NCT01105897     History of Changes
Other Study ID Numbers: ETLQ62/81
Study First Received: April 15, 2010
Last Updated: August 30, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by PaijatHame Central Hospital:
endometriosis
deep endometriosis
surgery
laparoscopy
chronic pain
quality of life
sexual function
complications
recurrence

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 18, 2014