Clinical trial NCT01105897: Prospective Study of the Outcomes of the Surgical Treatment of Deeply Infiltrating Endometriosis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: endometriosis
deep endometriosis
surgery
laparoscopy
chronic pain
quality of life
sexual function
complications
recurrence
Lead sponsor: PaijatHame Central Hospital
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility 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.

Primary outcomes:
measure: Endometriosis related pain symptoms before, and one year after the endometriosis surgery
timeFrame: 12 months
measure: The incidence of deeply infiltrating lesions among surgically treated endometriosis patients.
timeFrame: 3 years
measure: Quality of life before, and one year after the endometriosis surgery
timeFrame: one year
measure: Sexual functioning of endometriosis patients before, and one year after the surgery
timeFrame: one year
measure: Complication related to surgical treatment of deeply infiltrating endometriosis with one year postoperative follow-up
timeFrame: one year
Secondary outcomes:
measure: Recurrence of endometriosis after surgical treatment
timeFrame: six years
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
Study officials:
affiliation: Päijänne Tavastia Central Hospital
name: Marjaleena Setälä, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Päijänne Tavastia Central Hospital
name: Jyrki Kössi, MD, PhD
role: STUDY_DIRECTOR
affiliation: Turku University Hospital, Turku, Finland
name: Juha Mäkinen, Prof.
role: STUDY_DIRECTOR
References:
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.
citation: Huhtinen K, Suvitie P, Hiissa J, Junnila J, Huvila J, Kujari H, Setala M, Harkki P, Jalkanen J, Fraser J, Makinen 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.
citation: Kossi J, Setala 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.
citation: Setala M, Savolainen H, Kossi J, Ranta T, Makinen 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.
citation: Setala M, Kossi J, Silventoinen S, Makinen 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.
citation: Kossi J, Setala M, Makinen J, Harkki 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.
citation: Setala M, Harkki P, Matomaki J, Makinen J, Kossi 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.x. Epub 2012 Apr 30.