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

NCT01105897 | Unknown

• 1 other identifier: ETLQ62/81
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Recurrence of endometriosis after surgical treatment

  six years

Study Arms (1)

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

Interventions

Endometriosis surgery PROCEDURE

Complete surgical excision of all visible endometriosis by multidisciplinary approach

Surgically treated endometriosis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Finnish speaking patients scheduled for operation on suspected endometriosis

You may not qualify if:

• Non-Finnish speaking patients
• Previous hysterectomy.
• Previous bilateral salpingo-oophorectomy
• Any cancer
• Chronic inflammatory bowel or bladder disease
• Diabetes treated with insulin
• Rheumatoid arthritis.

Sponsors & Collaborators

• PaijatHame Central Hospital: lead

Study Sites (1)

Päijät-Häme Central Hospital

Lahti, Lahti, 15850, Finland

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  PMID: 19337252 BACKGROUND

• 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.

  PMID: 19438891 RESULT

• 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.

  PMID: 21314818 RESULT

• 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.

  PMID: 21621895 RESULT

• 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.

  PMID: 22642851 RESULT

• 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.

  PMID: 22404128 RESULT

MeSH Terms

Conditions

Endometriosis; Chronic Pain; Recurrence

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Marjaleena Setälä, MD

  Päijänne Tavastia Central Hospital

  PRINCIPAL INVESTIGATOR

• Jyrki Kössi, MD, PhD

  Päijänne Tavastia Central Hospital

  STUDY DIRECTOR

• Juha Mäkinen, Prof.

  Turku University Hospital, Turku, Finland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 19, 2010
• Study Start: January 1, 2005
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

FI (1)