<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/NCT03257332</url>
  </required_header>
  <id_info>
    <org_study_id>EDFI-Cohort</org_study_id>
    <nct_id>NCT03257332</nct_id>
  </id_info>
  <brief_title>Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.</brief_title>
  <acronym>EDFI-Cohort</acronym>
  <official_title>The EDFI-Cohort: Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Curative Surgery for Rectal Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Slagelse Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Association of Danish Physiotherapists</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Slagelse Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background:&#xD;
&#xD;
      Patients treated for rectal cancer are in high risk of developing poor quality of life and&#xD;
      faecal incontinence. Faecal incontinence has a negative impact on quality of life. However,&#xD;
      there is limited knowledge on how to prevent it. Known exposures are ; age at surgery,&#xD;
      gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In&#xD;
      order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate&#xD;
      the anorectal muscle function for sensory and motor impairment. Exposures representing&#xD;
      different constructs in the biopsychosocial model are likewise likely to be associated with&#xD;
      quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary&#xD;
      incontinence, fatique, physical inactivity and finding meaning in life. There are to our&#xD;
      knowledge, no records on these relationships from prior to surgery to 2 years after. These&#xD;
      biopsychosocial exposures are central to include when developing strategies that can prevent&#xD;
      poor quality of life and faecal incontinence for patients treated for rectal cancer.&#xD;
&#xD;
      Purpose:&#xD;
&#xD;
      The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical&#xD;
      technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual&#xD;
      dysfunction, fatigue, physical activity and finding meaning in life) develop over time and&#xD;
      predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer&#xD;
      from prior to surgery to 2 years after primary treatment.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      We will include subjects diagnosed with rectal cancer and have received curative surgery (low&#xD;
      anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to&#xD;
      recruit all eligible patients in a one year period. We estimate to recruit 70 patients.&#xD;
&#xD;
      Self-reported outcomes will be collected with a series of validated questionnaires that&#xD;
      subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and&#xD;
      104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29)&#xD;
      and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal&#xD;
      incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and&#xD;
      (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding&#xD;
      meaning in life (SOME).&#xD;
&#xD;
      Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and&#xD;
      include: Anorectal manometry that measures anorectal muscle function and rectal perception, a&#xD;
      digital examination of anorectal muscle function using the Digital Rectal Examination Scoring&#xD;
      System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity.&#xD;
&#xD;
      We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple&#xD;
      linear regression models for the continuous data. We plan to adjust for known confounders and&#xD;
      variables related to treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not possible to include participants&#xD;
  </why_stopped>
  <start_date type="Actual">November 12, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Global health status/quality of life: EORTC QLQ-C30</measure>
    <time_frame>104 weeks</time_frame>
    <description>European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Low anterior resection syndrome</measure>
    <time_frame>104 weeks</time_frame>
    <description>Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Urinary incontinence</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)</description>
  </other_outcome>
  <other_outcome>
    <measure>Urinary incontinence - Urinary symptoms</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>International Consultation on Incontinence Questionnaire - Male/female Lower Urinary Tract Symptoms (ICIQ-MLUTS og ICIQ-FLUTS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Urinary incontinence - Sexual dysfunction</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>International Consultation on Incontinence Questionnaire - Male/female Sexual Matters associated with Lower Urinary Tract Symptoms (ICIQ-MLUTSsex or ICIQ-FLUTSsex)</description>
  </other_outcome>
  <other_outcome>
    <measure>Global health status/quality of life: EORTC QLQ-C30</measure>
    <time_frame>3, 6, 12, 26 and 52 weeks</time_frame>
    <description>European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)</description>
  </other_outcome>
  <other_outcome>
    <measure>Other subscales than 'global health status/quality of life': EORTC QLQ-C30</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life - colorectal cancer: EORTC QLQ-CR29</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>European Organisation for Research and Treatment of Cancer's colorectal cancer module (EORTC QLQ-CR29)</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life - Fatigue: EORTC QLQ-FA12</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>European Organisation for Research and Treatment of Cancer's fatigue module (EORTC QLQ-FA12)</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life - INFO: EORTC QLQ-INFO25</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>European Organisation for Research and Treatment of Cancer's information about disease and treatment module (EORTC QLQ-INFO25)</description>
  </other_outcome>
  <other_outcome>
    <measure>Anorectal muscle function - digital examination</measure>
    <time_frame>6, 26, 52 and 104 weeks</time_frame>
    <description>Maximal resting pressure Maximal squeeze pressure Endurance squeeze - max squeeze pressure or longest time Latency (rate of force development), number of rectal muscle contractions/squeezes in 15 sec test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anorectal Manometry - pressure</measure>
    <time_frame>6, 26, 52 and 104 weeks</time_frame>
    <description>Maximal resting pressure Maximal squeeze pressure Maximal squeeze pressure duration</description>
  </other_outcome>
  <other_outcome>
    <measure>Anorectal Manometry - capacity</measure>
    <time_frame>6, 26, 52 and 104 weeks</time_frame>
    <description>Volume capacity measurements:&#xD;
Maximal tolerated volume Conscious rectal sensitivity threshold Conscious rectal sensitivity Constant sensation</description>
  </other_outcome>
  <other_outcome>
    <measure>Faecal incontinence</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>Self-reported questionnaire - St. Marks Incontinence score (Vaizey score)</description>
  </other_outcome>
  <other_outcome>
    <measure>Low anterior resection syndrome</measure>
    <time_frame>3, 6, 12, 26 and 52 weeks</time_frame>
    <description>Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity level</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>physical activity section of the Danish National Health Profile</description>
  </other_outcome>
  <other_outcome>
    <measure>Finding meaning in life</measure>
    <time_frame>3, 6, 12, 26, 52 and 104 weeks</time_frame>
    <description>Sources of Meaning and Meaning in Life Questionnaire (SoMe)</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical performance</measure>
    <time_frame>6, 26, 52 and 104 weeks</time_frame>
    <description>6-Minute Walk test</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Rectum Cancer</condition>
  <condition>Quality of Life</condition>
  <condition>Faecal Incontinence</condition>
  <condition>Low Anterior Resection Syndrome</condition>
  <arm_group>
    <arm_group_label>EDFI Cohort</arm_group_label>
    <description>Subjects should have received surgery for rectal cancer (low anterior resection).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Low Anterior Resection for Rectum Cancer</intervention_name>
    <description>Subjects should have received curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant (radiation/chemo) therapy.</description>
    <arm_group_label>EDFI Cohort</arm_group_label>
    <other_name>Total mesorectal excision</other_name>
    <other_name>Partial mesorectal excision</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects for the EDFI-Cohort study will be recruited during 2019 and 2020 from Department&#xD;
        of Surgery, Slagelse, and Zealand University Hospital, Køge. Subjects need to be diagnosed&#xD;
        with rectal cancer and have received curative surgery (low anterior resection) with/without&#xD;
        adjuvant (radiation/chemo) therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of rectal cancer&#xD;
&#xD;
          -  Low anterior resection (e.g. not limited to total mesorectal excision (TME) or partial&#xD;
             mesorectal excision (PME))&#xD;
&#xD;
          -  Ability to communicate in Danish&#xD;
&#xD;
          -  Adults (&gt; 18 years of age)&#xD;
&#xD;
          -  American Society of Anaesthesiologists (ASA) score: I-IV.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA score of: V-VI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Søren T Skou, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Slagelse Sygehus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ismail Gögenur, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Zealand University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zealand University Hospital</name>
      <address>
        <city>Køge</city>
        <state>Region Zealand</state>
        <zip>DK-4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slagelse Hospital</name>
      <address>
        <city>Slagelse</city>
        <state>Region Zealand</state>
        <zip>DK-4200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Emmertsen KJ, Laurberg S; Rectal Cancer Function Study Group. Impact of bowel dysfunction on quality of life after sphincter-preserving resection for rectal cancer. Br J Surg. 2013 Sep;100(10):1377-87. doi: 10.1002/bjs.9223.</citation>
    <PMID>23939851</PMID>
  </reference>
  <reference>
    <citation>Lai X, Wong FK, Ching SS. Review of bowel dysfunction of rectal cancer patients during the first five years after sphincter-preserving surgery: a population in need of nursing attention. Eur J Oncol Nurs. 2013 Oct;17(5):681-92. doi: 10.1016/j.ejon.2013.06.001. Epub 2013 Jul 17.</citation>
    <PMID>23871359</PMID>
  </reference>
  <reference>
    <citation>Ma B, Gao P, Song Y, Zhang C, Zhang C, Wang L, Liu H, Wang Z. Transanal total mesorectal excision (taTME) for rectal cancer: a systematic review and meta-analysis of oncological and perioperative outcomes compared with laparoscopic total mesorectal excision. BMC Cancer. 2016 Jul 4;16:380. doi: 10.1186/s12885-016-2428-5.</citation>
    <PMID>27377924</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Slagelse Hospital</investigator_affiliation>
    <investigator_full_name>Brian Clausen</investigator_full_name>
    <investigator_title>Physiotherapist and PhD</investigator_title>
  </responsible_party>
  <keyword>Rectum cancer</keyword>
  <keyword>Low Anterior Rectal Syndrome</keyword>
  <keyword>Anorectal muscle function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Low Anterior Resection Syndrome</mesh_term>
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Reseachers whom are interested in study data, are welcome to contact study PI.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03257332/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03257332/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03257332
org study id: EDFI-Cohort
nct id: NCT03257332
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background:

      Patients treated for rectal cancer are in high risk of developing poor quality of life and
      faecal incontinence. Faecal incontinence has a negative impact on quality of life. However,
      there is limited knowledge on how to prevent it. Known exposures are ; age at surgery,
      gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In
      order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate
      the anorectal muscle function for sensory and motor impairment. Exposures representing
      different constructs in the biopsychosocial model are likewise likely to be associated with
      quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary
      incontinence, fatique, physical inactivity and finding meaning in life. There are to our
      knowledge, no records on these relationships from prior to surgery to 2 years after. These
      biopsychosocial exposures are central to include when developing strategies that can prevent
      poor quality of life and faecal incontinence for patients treated for rectal cancer.

      Purpose:

      The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical
      technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual
      dysfunction, fatigue, physical activity and finding meaning in life) develop over time and
      predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer
      from prior to surgery to 2 years after primary treatment.

      Methods:

      We will include subjects diagnosed with rectal cancer and have received curative surgery (low
      anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to
      recruit all eligible patients in a one year period. We estimate to recruit 70 patients.

      Self-reported outcomes will be collected with a series of validated questionnaires that
      subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and
      104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29)
      and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal
      incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and
      (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding
      meaning in life (SOME).

      Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and
      include: Anorectal manometry that measures anorectal muscle function and rectal perception, a
      digital examination of anorectal muscle function using the Digital Rectal Examination Scoring
      System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity.

      We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple
      linear regression models for the continuous data. We plan to adjust for known confounders and
      variables related to treatment.
observational model: Cohort
time perspective: Prospective
measure: Global health status/quality of life: EORTC QLQ-C30
time frame: 104 weeks
description: European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)
measure: Low anterior resection syndrome
time frame: 104 weeks
description: Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)
measure: Urinary incontinence
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
measure: Urinary incontinence - Urinary symptoms
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: International Consultation on Incontinence Questionnaire - Male/female Lower Urinary Tract Symptoms (ICIQ-MLUTS og ICIQ-FLUTS)
measure: Urinary incontinence - Sexual dysfunction
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: International Consultation on Incontinence Questionnaire - Male/female Sexual Matters associated with Lower Urinary Tract Symptoms (ICIQ-MLUTSsex or ICIQ-FLUTSsex)
measure: Global health status/quality of life: EORTC QLQ-C30
time frame: 3, 6, 12, 26 and 52 weeks
description: European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)
measure: Other subscales than 'global health status/quality of life': EORTC QLQ-C30
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)
measure: Quality of life - colorectal cancer: EORTC QLQ-CR29
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: European Organisation for Research and Treatment of Cancer's colorectal cancer module (EORTC QLQ-CR29)
measure: Quality of life - Fatigue: EORTC QLQ-FA12
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: European Organisation for Research and Treatment of Cancer's fatigue module (EORTC QLQ-FA12)
measure: Quality of life - INFO: EORTC QLQ-INFO25
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: European Organisation for Research and Treatment of Cancer's information about disease and treatment module (EORTC QLQ-INFO25)
measure: Anorectal muscle function - digital examination
time frame: 6, 26, 52 and 104 weeks
description: Maximal resting pressure Maximal squeeze pressure Endurance squeeze - max squeeze pressure or longest time Latency (rate of force development), number of rectal muscle contractions/squeezes in 15 sec test.
measure: Anorectal Manometry - pressure
time frame: 6, 26, 52 and 104 weeks
description: Maximal resting pressure Maximal squeeze pressure Maximal squeeze pressure duration
measure: Anorectal Manometry - capacity
time frame: 6, 26, 52 and 104 weeks
description: Volume capacity measurements:
Maximal tolerated volume Conscious rectal sensitivity threshold Conscious rectal sensitivity Constant sensation
measure: Faecal incontinence
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: Self-reported questionnaire - St. Marks Incontinence score (Vaizey score)
measure: Low anterior resection syndrome
time frame: 3, 6, 12, 26 and 52 weeks
description: Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)
measure: Physical activity level
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: physical activity section of the Danish National Health Profile
measure: Finding meaning in life
time frame: 3, 6, 12, 26, 52 and 104 weeks
description: Sources of Meaning and Meaning in Life Questionnaire (SoMe)
measure: Physical performance
time frame: 6, 26, 52 and 104 weeks
description: 6-Minute Walk test
arm group label: EDFI Cohort
description: Subjects should have received surgery for rectal cancer (low anterior resection).
intervention type: Procedure
intervention name: Low Anterior Resection for Rectum Cancer
description: Subjects should have received curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant (radiation/chemo) therapy.
arm group label: EDFI Cohort
other name: Total mesorectal excision
other name: Partial mesorectal excision
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Søren T Skou, PhD
role: Study Chair
affiliation: Slagelse Sygehus
last name: Ismail Gögenur, PhD
role: Study Chair
affiliation: Zealand University Hospital
facility: 
facility: 
country: Denmark
citation: Emmertsen KJ, Laurberg S; Rectal Cancer Function Study Group. Impact of bowel dysfunction on quality of life after sphincter-preserving resection for rectal cancer. Br J Surg. 2013 Sep;100(10):1377-87. doi: 10.1002/bjs.9223.
PMID: 23939851
citation: Lai X, Wong FK, Ching SS. Review of bowel dysfunction of rectal cancer patients during the first five years after sphincter-preserving surgery: a population in need of nursing attention. Eur J Oncol Nurs. 2013 Oct;17(5):681-92. doi: 10.1016/j.ejon.2013.06.001. Epub 2013 Jul 17.
PMID: 23871359
citation: Ma B, Gao P, Song Y, Zhang C, Zhang C, Wang L, Liu H, Wang Z. Transanal total mesorectal excision (taTME) for rectal cancer: a systematic review and meta-analysis of oncological and perioperative outcomes compared with laparoscopic total mesorectal excision. BMC Cancer. 2016 Jul 4;16:380. doi: 10.1186/s12885-016-2428-5.
PMID: 27377924
responsible party type: Principal Investigator
investigator affiliation: Slagelse Hospital
investigator full name: Brian Clausen
investigator title: Physiotherapist and PhD
mesh term: Rectal Neoplasms
mesh term: Low Anterior Resection Syndrome
mesh term: Fecal Incontinence
sharing ipd: Undecided
ipd description: Reseachers whom are interested in study data, are welcome to contact study PI.
provided document: 
provided document: 