<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779256</url>
  </required_header>
  <id_info>
    <org_study_id>2017/1925 REK Sør-Øst D</org_study_id>
    <nct_id>NCT03779256</nct_id>
  </id_info>
  <brief_title>Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life</brief_title>
  <acronym>ENDO</acronym>
  <official_title>ENDO - Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO1, ENDO2, ENDO3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St John of God Hospital, Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nepean Blue Mountains Local Health District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endometriosis on the bowel is a benign condition that can cause major complaints and severely&#xD;
      affect the quality of life of women of fertile age. If medical treatment is not enough to&#xD;
      improve pain and/or other symptoms it may be necessary to undergo major surgical treatment&#xD;
      and removal of the endometriosis nodule on the bowel. Such extensive surgical treatment&#xD;
      carries risks of serious complications. Therefore, a thorough diagnostic work-up before&#xD;
      surgery is important to know the extent of disease. This will provide women with the best&#xD;
      possible information and for the surgeon to plan the operation. The risk of complications&#xD;
      increases as the bowel endometriosis is localized closer to the anus as well and/or if the&#xD;
      bowel nodule is large.&#xD;
&#xD;
      The distance between the anus and the nodule and the size of the nodule can be measured with&#xD;
      two dimensional (2D) vaginal ultrasound. Additionally, Magnetic resonance imaging (MRI) is&#xD;
      also used in some countries for these same measurements. Our study would like to investigate&#xD;
      the diagnostic value of 2D ultrasound and MRI as well as learn more about women's quality of&#xD;
      life before and after surgery. The investigators have designed the study to evaluate the&#xD;
      following three questions into three studies ENDO1, ENDO2 and ENDO3:&#xD;
&#xD;
        -  ENDO1: How good is 2D transvaginal ultrasound at measuring the size of the bowel&#xD;
           endometriosis nodule and the distance between anus and the lower part of the bowel&#xD;
           nodule compared to measurements done during surgery?&#xD;
&#xD;
        -  ENDO2: What is the quality of life, sexual and bowel function of women before and 3- and&#xD;
           12-months after surgery due to bowel endometriosis? Questionnaires will be used.&#xD;
&#xD;
        -  ENDO3: How good is 2D transvaginal ultrasound at measuring the size of the bowel&#xD;
           endometriosis nodule compared to magnetic resonance imaging (MRI) and measurements done&#xD;
           during surgery?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mild endometriosis normally affects the peritoneum. More advanced form of endometriosis is&#xD;
      termed deep infiltrating endometriosis (DIE). In women suffering from DIE, the endometriotic&#xD;
      tissue invades the tissue &gt;5mm below the peritoneal surface, affecting organs in the pelvis&#xD;
      like the ovaries, uterus, vagina, bladder, ureters and/or bowel. In women with suspected&#xD;
      endometriosis, the prevalence of DIE affecting the bowel is found to range from 24.0 to&#xD;
      73.3%. The symptoms of DIE can be debilitating with dysmenorrhoea, dyspareunia, altered bowel&#xD;
      motions, dyschezia and/or dysuria. Thus, it may have an immense impact on women's quality of&#xD;
      life with societal consequences.&#xD;
&#xD;
      The risk of complications with surgery for deep infiltrating endometriosis (DIE) of the bowel&#xD;
      can be severe like anastomotic leak and rectovaginal fistula. Evidence show that there is an&#xD;
      increased risk of anastomotic leaks bowel if the anastomosis &lt;5-8cm from the anal verge. DIE&#xD;
      of the rectosigmoid colon can be diagnosed by widely available and low-cost two-dimensional&#xD;
      transvaginal sonograhpy (2D-TVS) with a high sensitivity and specificity. MRI is comparable&#xD;
      to TVS in diagnosis of intestinal endometriosis but is costlier and less available than TVS.&#xD;
      MRI has the advantage over 2D-TVS that it is reproducible, the area of interest can be viewed&#xD;
      in many planes and the images can be reviewed and compared by same or different examiners&#xD;
      over time.&#xD;
&#xD;
      There are two surgical approaches used in women suffering from bowel endometriosis, namely&#xD;
      segmental resection of rectosigmoid or nodule excision. Nodule excision may be performed by&#xD;
      shaving (not opening the rectum) or disc excision (removing bowel nodule with surrounding&#xD;
      rectal wall). The success of pelvic pain reduction following surgery in women suffering from&#xD;
      DIE is related to the radicality of surgery. However, some argue a more symptom-guided&#xD;
      approach to surgery.&#xD;
&#xD;
      Endometriosis itself and surgical treatment may have immense impact endometriosis can have on&#xD;
      a woman's life. Thus, it is essential to discuss the severity of symptoms, any implications&#xD;
      of surgery as well as the risk of complications to enable women informed consent. The&#xD;
      pre-operative information and decision making is based on symptoms, fertility wish, the&#xD;
      clinical examination and diagnostic tests. Consequently, diagnostic tools such as TVS and MRI&#xD;
      are important factors to plan and perform a safe procedure with the best possible outcomes&#xD;
      for the women.&#xD;
&#xD;
      There are, to the investigator's knowledge, no studies, which demonstrate if there is a&#xD;
      correlation between measurement of the size of an endometriotic rectosigmoid lesion with&#xD;
      2D-TVS compared to the actual lesion size in the resected bowel. Additionally, there are no&#xD;
      studies that investigate the correlation between the distance between the rectosigmoid lesion&#xD;
      and the anal verge, to plan appropriate surgery and estimate risk of serious complications.&#xD;
      Furthermore, there are no known studies evaluating the correlation of measurements of bowel&#xD;
      lesions when comparing transvaginal 2D-TVS, MRI and surgery. The aim of surgery is to improve&#xD;
      women's quality of life and thus it is essential to evaluate results before and after surgery&#xD;
      for bowel endometriosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">March 8, 2021</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ENDO1AMeasurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS</measure>
    <time_frame>Before scheduled surgery</time_frame>
    <description>Millimeter distance measured on 2D TVS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ENDO1A: Measurements on the distance between the lower margin of the rectal lesion and anal verge</measure>
    <time_frame>During scheduled surgery</time_frame>
    <description>Millimeter distance measured during surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ENDO1B: Size of bowel lesion measured on the excised bowel lesion.</measure>
    <time_frame>During surgery.</time_frame>
    <description>Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ENDO1B: Size of bowel lesion measured with 2D-TVS.</measure>
    <time_frame>Before scheduled surgery.</time_frame>
    <description>Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ENDO2: Incidence of low anterior resection syndrome (LARS)</measure>
    <time_frame>Preoperatively, 3- and 12-months postoperatively</time_frame>
    <description>LARS questionnaire consisting of five questions, each response correlates to a score. Lowest score is 0-20 i.e. no LARS, score 21-29 i.e. minor LARS and score 30-42 i.e. major LARS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ENDO3: Correlation between Lesion to anal verge distance (LAVD) measured with 2D-TVS, MRI and measurements during surgery</measure>
    <time_frame>Pre-operatively and during surgery</time_frame>
    <description>Millimeters of lesion to anal verge distance measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ENDO3: Measurements of bowel lesion size with MRI compared to 2D TVS and surgery</measure>
    <time_frame>Before and during scheduled surgery</time_frame>
    <description>Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria.</measure>
    <time_frame>Preoperatively, 3 and 12 months postoperatively</time_frame>
    <description>Numerical analogue scale ranging from 0 to 10 scored for each symptom, 0 representing no pain and 10 representing worst possible pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ENDO1: Type and frequency of complications after bowel surgery</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>&quot;Clavien-Dindo&quot; classification of surgical complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ENDO2: Quality of life Endometriosis Health Profile-30</measure>
    <time_frame>Preoperatively, 3 and 12 months postoperatively</time_frame>
    <description>Using questionnaire - Endometriosis Health Profile (EHP-30), consisting of a core questionnaire with 30 items grouped into 5 scales and modular questionnaire consisting of 23 items grouped into 6 scales. All scales have a minimum score of 0 (indicating low disability) and a maximum score of 100 (indicating high disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ENDO2: Sexual function</measure>
    <time_frame>Preoperatively, 3 and 12 months postoperatively</time_frame>
    <description>Using questionnaire - Female Sexual Function Index (FSFI) consisting of 19 questions, minimum score 2.0 (worst score), maximum score 36.0 (best score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ENDO2: Quality of life before bowel surgery</measure>
    <time_frame>Before surgery</time_frame>
    <description>GIQLI (gastrointestinal quality of life index) questionnaire. 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ENDO2: Quality of life after bowel surgery</measure>
    <time_frame>3 months</time_frame>
    <description>GIQLI questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ENDO2: Quality of life after bowel surgery</measure>
    <time_frame>12 months</time_frame>
    <description>GIQLI questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">207</enrollment>
  <condition>Endometriosis Related Pain</condition>
  <condition>Quality of Life</condition>
  <condition>Pain, Chronic</condition>
  <condition>Bowel Dysfunction</condition>
  <condition>Endometriosis Rectum</condition>
  <condition>Deep Infiltrating Endometriosis</condition>
  <condition>Deep Endometriosis</condition>
  <arm_group>
    <arm_group_label>Women with bowel endometriosis.</arm_group_label>
    <description>Women with symptomatic bowel endometriosis scheduled for surgical treatment investigated with 2D transvaginal ultrasound before surgery at Hospital St John of God, Vienna, Austria; Oslo university hospital, Oslo, Norway and Nepean Hospital, Sydney, Australia.&#xD;
The women recruited at Oslo university hospital, Norway will also have a magnetic resonance imaging (MRI) of the abdomen and pelvis before surger.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>2D transvaginal ultrasound</intervention_name>
    <description>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.&#xD;
Women recruited at Oslo university hospital, Norway will also have an MRI performed pre-operatively.</description>
    <arm_group_label>Women with bowel endometriosis.</arm_group_label>
    <other_name>Segmental bowel resection or</other_name>
    <other_name>Disc excision of bowel</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bowel excised by discoid excision or segmental resection sent for histopathological&#xD;
      examination, which is routine practice after surgery.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible women will be included from tertiary referral centers for deep infiltrating&#xD;
        endometriosis.&#xD;
&#xD;
        ENDO1 will include women from Oslo University Hospital, Hospital St John of God and Nepean&#xD;
        Hospital. Estimated total eligible women: 135.&#xD;
&#xD;
        ENDO2 will include women from Oslo University Hospital and Nepean Hospital. Estimated&#xD;
        eligible women: 70.&#xD;
&#xD;
        ENDO3 will include women from Oslo University Hospital. Estimated eligible women: 40&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Women of reproductive age, ≥ 18 years old, scheduled for planned laparoscopic or open&#xD;
        bowel surgery for deep infiltrating endometriosis with suspected symptomatic bowel lesions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Postmenopausal women, women &lt; 18 years old, women with previous bowel surgery. Women who&#xD;
        do not speak and read fluent English or Norwegian.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mee Kristine Aas-Eng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nepean Hospital</name>
      <address>
        <city>Sydney</city>
        <zip>NSW2747</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital St John of God</name>
      <address>
        <city>Vienna</city>
        <zip>1020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo university hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Norway</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Kristine Aas-Eng</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Deep infiltrating endometriosis</keyword>
  <keyword>Transvaginal ultrasound</keyword>
  <keyword>Endometriosis rectum</keyword>
  <keyword>Conservative surgery</keyword>
  <keyword>Radical surgery</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Deep endometriosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779256
org study id: 2017/1925 REK Sør-Øst D
nct id: NCT03779256
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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?
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.
observational model: Cohort
time perspective: Prospective
measure: ENDO1AMeasurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS
time frame: Before scheduled surgery
description: Millimeter distance measured on 2D TVS
measure: ENDO1A: Measurements on the distance between the lower margin of the rectal lesion and anal verge
time frame: During scheduled surgery
description: Millimeter distance measured during surgery
measure: ENDO1B: Size of bowel lesion measured on the excised bowel lesion.
time frame: During surgery.
description: Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
measure: ENDO1B: Size of bowel lesion measured with 2D-TVS.
time frame: Before scheduled surgery.
description: Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
measure: ENDO2: Incidence of low anterior resection syndrome (LARS)
time frame: Preoperatively, 3- and 12-months postoperatively
description: LARS questionnaire consisting of five questions, each response correlates to a score. Lowest score is 0-20 i.e. no LARS, score 21-29 i.e. minor LARS and score 30-42 i.e. major LARS.
measure: ENDO3: Correlation between Lesion to anal verge distance (LAVD) measured with 2D-TVS, MRI and measurements during surgery
time frame: Pre-operatively and during surgery
description: Millimeters of lesion to anal verge distance measured
measure: ENDO3: Measurements of bowel lesion size with MRI compared to 2D TVS and surgery
time frame: Before and during scheduled surgery
description: Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
measure: ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria.
time frame: Preoperatively, 3 and 12 months postoperatively
description: Numerical analogue scale ranging from 0 to 10 scored for each symptom, 0 representing no pain and 10 representing worst possible pain
measure: ENDO1: Type and frequency of complications after bowel surgery
time frame: Through study completion, an average of 1 year
description: "Clavien-Dindo" classification of surgical complications
measure: ENDO2: Quality of life Endometriosis Health Profile-30
time frame: Preoperatively, 3 and 12 months postoperatively
description: Using questionnaire - Endometriosis Health Profile (EHP-30), consisting of a core questionnaire with 30 items grouped into 5 scales and modular questionnaire consisting of 23 items grouped into 6 scales. All scales have a minimum score of 0 (indicating low disability) and a maximum score of 100 (indicating high disability).
measure: ENDO2: Sexual function
time frame: Preoperatively, 3 and 12 months postoperatively
description: Using questionnaire - Female Sexual Function Index (FSFI) consisting of 19 questions, minimum score 2.0 (worst score), maximum score 36.0 (best score).
measure: ENDO2: Quality of life before bowel surgery
time frame: Before surgery
description: GIQLI (gastrointestinal quality of life index) questionnaire. 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.
measure: ENDO2: Quality of life after bowel surgery
time frame: 3 months
description: GIQLI questionnaire
measure: ENDO2: Quality of life after bowel surgery
time frame: 12 months
description: GIQLI questionnaire
arm group label: Women with bowel endometriosis.
description: Women with symptomatic bowel endometriosis scheduled for surgical treatment investigated with 2D transvaginal ultrasound before surgery at Hospital St John of God, Vienna, Austria; Oslo university hospital, Oslo, Norway and Nepean Hospital, Sydney, Australia.
The women recruited at Oslo university hospital, Norway will also have a magnetic resonance imaging (MRI) of the abdomen and pelvis before surger.
intervention type: Procedure
intervention name: 2D transvaginal ultrasound
description: 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.
arm group label: Women with bowel endometriosis.
other name: Segmental bowel resection or
other name: Disc excision of bowel
Bowel excised by discoid excision or segmental resection sent for histopathological
      examination, which is routine practice after surgery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mee Kristine Aas-Eng, MD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
facility: 
facility: 
country: Australia
country: Austria
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Kristine Aas-Eng
investigator title: Principal investigator
mesh term: Intestinal Diseases
mesh term: Endometriosis
mesh term: Chronic Pain
sharing ipd: Undecided