Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life
Condition: Endometriosis Related Pain; Quality of Life; Pain, Chronic; Bowel Dysfunction; Endometriosis Rectum; Deep Infiltrating Endometriosis; Deep Endometriosis
MeSH terms: Intestinal Diseases; Endometriosis; Chronic Pain
Study type: Observational

Summary: 
      Endometriosis on the bowel is a benign condition that can cause major complaints and severely
      affect the quality of life of women of fertile age. If medical treatment is not enough to
      improve pain and/or other symptoms it may be necessary to undergo major surgical treatment
      and removal of the endometriosis nodule on the bowel. Such extensive surgical treatment
      carries risks of serious complications. Therefore, a thorough diagnostic work-up before
      surgery is important to know the extent of disease. This will provide women with the best
      possible information and for the surgeon to plan the operation. The risk of complications
      increases as the bowel endometriosis is localized closer to the anus as well and/or if the
      bowel nodule is large.

      The distance between the anus and the nodule and the size of the nodule can be measured with
      two dimensional (2D) vaginal ultrasound. Additionally, Magnetic resonance imaging (MRI) is
      also used in some countries for these same measurements. Our study would like to investigate
      the diagnostic value of 2D ultrasound and MRI as well as learn more about women's quality of
      life before and after surgery. The investigators have designed the study to evaluate the
      following three questions into three studies ENDO1, ENDO2 and ENDO3:

        -  ENDO1: How good is 2D transvaginal ultrasound at measuring the size of the bowel
           endometriosis nodule and the distance between anus and the lower part of the bowel
           nodule compared to measurements done during surgery?

        -  ENDO2: What is the quality of life, sexual and bowel function of women before and 3- and
           12-months after surgery due to bowel endometriosis? Questionnaires will be used.

        -  ENDO3: How good is 2D transvaginal ultrasound at measuring the size of the bowel
           endometriosis nodule compared to magnetic resonance imaging (MRI) and measurements done
           during surgery?
    

Detailed description: 
      Mild endometriosis normally affects the peritoneum. More advanced form of endometriosis is
      termed deep infiltrating endometriosis (DIE). In women suffering from DIE, the endometriotic
      tissue invades the tissue >5mm below the peritoneal surface, affecting organs in the pelvis
      like the ovaries, uterus, vagina, bladder, ureters and/or bowel. In women with suspected
      endometriosis, the prevalence of DIE affecting the bowel is found to range from 24.0 to
      73.3%. The symptoms of DIE can be debilitating with dysmenorrhoea, dyspareunia, altered bowel
      motions, dyschezia and/or dysuria. Thus, it may have an immense impact on women's quality of
      life with societal consequences.

      The risk of complications with surgery for deep infiltrating endometriosis (DIE) of the bowel
      can be severe like anastomotic leak and rectovaginal fistula. Evidence show that there is an
      increased risk of anastomotic leaks bowel if the anastomosis <5-8cm from the anal verge. DIE
      of the rectosigmoid colon can be diagnosed by widely available and low-cost two-dimensional
      transvaginal sonograhpy (2D-TVS) with a high sensitivity and specificity. MRI is comparable
      to TVS in diagnosis of intestinal endometriosis but is costlier and less available than TVS.
      MRI has the advantage over 2D-TVS that it is reproducible, the area of interest can be viewed
      in many planes and the images can be reviewed and compared by same or different examiners
      over time.

      There are two surgical approaches used in women suffering from bowel endometriosis, namely
      segmental resection of rectosigmoid or nodule excision. Nodule excision may be performed by
      shaving (not opening the rectum) or disc excision (removing bowel nodule with surrounding
      rectal wall). The success of pelvic pain reduction following surgery in women suffering from
      DIE is related to the radicality of surgery. However, some argue a more symptom-guided
      approach to surgery.

      Endometriosis itself and surgical treatment may have immense impact endometriosis can have on
      a woman's life. Thus, it is essential to discuss the severity of symptoms, any implications
      of surgery as well as the risk of complications to enable women informed consent. The
      pre-operative information and decision making is based on symptoms, fertility wish, the
      clinical examination and diagnostic tests. Consequently, diagnostic tools such as TVS and MRI
      are important factors to plan and perform a safe procedure with the best possible outcomes
      for the women.

      There are, to the investigator's knowledge, no studies, which demonstrate if there is a
      correlation between measurement of the size of an endometriotic rectosigmoid lesion with
      2D-TVS compared to the actual lesion size in the resected bowel. Additionally, there are no
      studies that investigate the correlation between the distance between the rectosigmoid lesion
      and the anal verge, to plan appropriate surgery and estimate risk of serious complications.
      Furthermore, there are no known studies evaluating the correlation of measurements of bowel
      lesions when comparing transvaginal 2D-TVS, MRI and surgery. The aim of surgery is to improve
      women's quality of life and thus it is essential to evaluate results before and after surgery
      for bowel endometriosis.
    

Intervention name(s): 2D transvaginal ultrasound
Intervention type(s): Procedure
Intervention description(s): Transvaginal ultrasound is part of routine pre-operative examination of the women before surgery is scheduled. Described surgical treatment interventions is standard practice used to alleviate patient symptoms.
Women recruited at Oslo university hospital, Norway will also have an MRI performed pre-operatively.
Other intervention name(s): Segmental bowel resection or; Disc excision of bowel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible women will be included from tertiary referral centers for deep infiltrating
        endometriosis.

        ENDO1 will include women from Oslo University Hospital, Hospital St John of God and Nepean
        Hospital. Estimated total eligible women: 135.

        ENDO2 will include women from Oslo University Hospital and Nepean Hospital. Estimated
        eligible women: 70.

        ENDO3 will include women from Oslo University Hospital. Estimated eligible women: 40
      
Biospecimen description: 
      Bowel excised by discoid excision or segmental resection sent for histopathological
      examination, which is routine practice after surgery.
    
Keywords: Deep infiltrating endometriosis; Transvaginal ultrasound; Endometriosis rectum; Conservative surgery; Radical surgery; Quality of life; Deep endometriosis