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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01105897
• Other study ID #: ETLQ62/81
• Status: Active, not recruiting
• Phase: N/A
• First received: April 15, 2010
• Last updated: August 30, 2012
• Start date: January 2005
• Est. completion date: December 2014

Study information

• Verified date: August 2012
• Source: PaijatHame Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• Endometriosis surgery
Complete surgical excision of all visible endometriosis by multidisciplinary approach

Locations

Country	Name	City	State
Finland	Päijät-Häme Central Hospital	Lahti

Sponsors (1)

Lead Sponsor	Collaborator
PaijatHame Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (7)

Huhtinen K, Suvitie P, Hiissa J, Junnila J, Huvila J, Kujari H, Setälä M, Härkki P, Jalkanen J, Fraser J, Mäkinen J, Auranen A, Poutanen M, Perheentupa A. Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts. Br J Cancer. 2009 Apr 21;100(8):1315-9. doi: 10.1038/sj.bjc.6605011. Epub 2009 Mar 31. — View Citation

Kössi J, Setälä M, Enholm B, Luostarinen M. The early outcome of laparoscopic sigmoid and rectal resection for endometriosis. Colorectal Dis. 2010 Mar;12(3):232-5. doi: 10.1111/j.1463-1318.2009.01923.x. Epub 2009 Apr 27. — View Citation

Kössi J, Setälä M, Mäkinen J, Härkki P, Luostarinen M. Quality of life and sexual function 1 year after laparoscopic rectosigmoid resection for endometriosis. Colorectal Dis. 2013 Jan;15(1):102-8. doi: 10.1111/j.1463-1318.2012.03111.x. — View Citation

Setälä M, Härkki P, Matomäki J, Mäkinen J, Kössi J. Sexual functioning, quality of life and pelvic pain 12 months after endometriosis surgery including vaginal resection. Acta Obstet Gynecol Scand. 2012 Jun;91(6):692-8. doi: 10.1111/j.1600-0412.2012.01394 — View Citation

Setälä M, Härkki P, Suvitie P, Fraser J, Jalkanen J, Kössi J, Perheentupa A, Mäkinen J. Is the presence of endometrioma always associated with more severe disease? Gynecol Surg, 2011 Jan. Epub ahead of print.

Setälä M, Kössi J, Silventoinen S, Mäkinen J. The impact of deep disease on surgical treatment of endometriosis. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):289-93. doi: 10.1016/j.ejogrb.2011.04.046. Epub 2011 May 31. — View Citation

Setälä M, Savolainen H, Kössi J, Ranta T, Mäkinen J. Deeply infiltrating disease in surgically treated endometriosis patients. Acta Obstet Gynecol Scand. 2011 May;90(5):468-72. doi: 10.1111/j.1600-0412.2011.01097.x. Epub 2011 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometriosis related pain symptoms before, and one year after the endometriosis surgery	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	No
Primary	The incidence of deeply infiltrating lesions among surgically treated endometriosis patients.	The incidence of deeply infiltrating endometriosis among consecutive patients operated on suspected endometriosis between January 2005- December 2007	3 years	No
Primary	Quality of life before, and one year after the endometriosis surgery	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	No
Primary	Sexual functioning of endometriosis patients before, and one year after the surgery	Sexual functioning measured with McCoy sexual functioning questionnaire before and one year after the surgery.	one year	No
Primary	Complication related to surgical treatment of deeply infiltrating endometriosis with one year postoperative follow-up	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	No
Secondary	Recurrence of endometriosis after surgical treatment	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	No