<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/NCT02190656</url>
  </required_header>
  <id_info>
    <org_study_id>009515</org_study_id>
    <nct_id>NCT02190656</nct_id>
  </id_info>
  <brief_title>Anterior Resection Syndrome Following Sphincter-preserving Surgery</brief_title>
  <official_title>Anterior Resection Syndrome Following Sphincter-preserving Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Royal College of Surgeons of England</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen Mary University of London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bowel cancer is the third most common cancer in the UK in both males and females. The rectum&#xD;
      is the most commonly affected part of the bowel. Improvements in surgery have meant that many&#xD;
      patients with rectal cancer can now undergo surgery that removes the rectum and avoids a&#xD;
      permanent stoma. The operation that most patients have is an anterior resection of the&#xD;
      rectum.&#xD;
&#xD;
      Unfortunately this surgery frequently leads to a change in bowel function, with patients&#xD;
      suffering from incontinence, urgency and unpredictability a problem known as anterior&#xD;
      resection syndrome. These problems are believed to be fairly common following surgery but&#xD;
      follow up appointments have traditionally concentrated on ensuring that the cancer has not&#xD;
      returned and have not reviewed functional outcomes in enough detail. Because of this we are&#xD;
      unsure exactly how common the problems described are.&#xD;
&#xD;
      The proposed study will allow us to determine how many patients have ongoing symptoms&#xD;
      following their surgery for rectal cancer. It will also allow us to use a newly developed&#xD;
      scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK&#xD;
      population, to ensure that it can accurately be used in the future to measure the problem and&#xD;
      aid development of new therapies. An appreciation of the impact of symptoms on postoperative&#xD;
      quality of life will encourage routine assessment of functional outcomes in clinical&#xD;
      practice, allowing identification of patients who may benefit from treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the main aims when carrying out surgery for rectal cancer is to avoid patients ending&#xD;
      up with a permanent stoma. The current standard operation for resection of the rectum is an&#xD;
      anterior resection. A large proportion of the patients undergoing this procedure develop&#xD;
      anterior resection syndrome, with significant alteration of their bowel habit, including&#xD;
      urgency, incontinence and unpredictability. Many definitions for this problem have been used&#xD;
      and until recently there was no specifically designed tool for measuring it. There has never&#xD;
      been a large scale study in the UK to tell us how common the problem is. A meta-analysis&#xD;
      combining results from small studies show marked variation in the frequency of symptoms&#xD;
      ranging from 285%, mainly because of the different methods of assessment used in the studies.&#xD;
&#xD;
      The LARS score was recently developed by a research group in Denmark. Their results show that&#xD;
      45.9% of patients had major LARS at 12 months following surgery. This is nearly half of all&#xD;
      patients in their sample and clearly represents an important problem.&#xD;
&#xD;
      Anterior resection syndrome is known to have a negative effect on quality of life. It is a&#xD;
      multifactorial condition and is increased in patients have chemotherapy and radiotherapy.&#xD;
      There are treatments available and also in development which may help patients. However in&#xD;
      clinical practice, patients are not routinely asked about their functional outcome and the&#xD;
      effect that these symptoms can have on patients' lives is often not discussed. The urgent&#xD;
      need for further research into the longterm functional effects of treatments for cancer has&#xD;
      been acknowledged by the National Institute for Health and Care Excellence (NICE) and the&#xD;
      National Cancer Survivorship Initiative.&#xD;
&#xD;
      Determining baseline prevalence in the UK and validating the LARS score will allow accurate&#xD;
      preoperative counselling of patients about functional outcomes following surgery for rectal&#xD;
      cancer. It will facilitate comparison between populations, further helping to determine risk&#xD;
      factors and aiding in development of therapeutic interventions. An appreciation of the impact&#xD;
      of anterior resection syndrome on postoperative quality of life will encourage routine&#xD;
      assessment of functional outcomes in clinical practice, allowing identification of patients&#xD;
      who may benefit from treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with no LARS; minor LARS and major LARS</measure>
    <time_frame>At the time of questionnaire completion</time_frame>
    <description>This will allow us to determine the prevalence of Low Anterior Resection Syndrome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between LARS score and EORTC QLQ-C30 questionnaire score</measure>
    <time_frame>At the time of questionnaire completion</time_frame>
    <description>The association between the LARS score and The European Organization for Research and Treatment of Cancer (EORTC) generic quality of life questionnaire QLQC30 will be used to establish validity of the LARS score. Ability of the score to differ between patient groups known to differ in postoperative function (for example, those who have had radiotherapy and those who have not) will also be used to assess validity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>LARS score in different age groups</measure>
    <time_frame>At time of questionnaire completion</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>LARS score in participants who have had laparoscopic surgery and participants who have had open surgery</measure>
    <time_frame>At time of questionnaire completion</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1197</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Anterior resection</arm_group_label>
    <description>Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients having had an anterior resection for rectal cancer who are more than 12 months&#xD;
        post surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having had an anterior resection for rectal cancer who are more than 12&#xD;
             months post surgery&#xD;
&#xD;
          -  Patients who are more than 12 months post reversal of any defunctioning stoma&#xD;
&#xD;
          -  Aged over 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any inclusion criteria not met&#xD;
&#xD;
          -  Presence of a stoma&#xD;
&#xD;
          -  Local recurrence of cancer&#xD;
&#xD;
          -  Current adjuvant therapy&#xD;
&#xD;
          -  Further rectal surgery after the initial operation&#xD;
&#xD;
          -  Insufficient written English to participate&#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>Mohamed Thaha, PhD FRCS</last_name>
    <role>Study Chair</role>
    <affiliation>Queen Mary University of London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary University of London</name>
      <address>
        <city>London</city>
        <zip>E1 2AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>March 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>April 4, 2016</last_update_submitted>
  <last_update_submitted_qc>April 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rectal cancer</keyword>
  <keyword>Anterior Resection Syndrome</keyword>
  <keyword>Functional outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02190656
org study id: 009515
nct id: NCT02190656
lead sponsor: 
collaborator: 
has dmc: No
Bowel cancer is the third most common cancer in the UK in both males and females. The rectum
      is the most commonly affected part of the bowel. Improvements in surgery have meant that many
      patients with rectal cancer can now undergo surgery that removes the rectum and avoids a
      permanent stoma. The operation that most patients have is an anterior resection of the
      rectum.

      Unfortunately this surgery frequently leads to a change in bowel function, with patients
      suffering from incontinence, urgency and unpredictability a problem known as anterior
      resection syndrome. These problems are believed to be fairly common following surgery but
      follow up appointments have traditionally concentrated on ensuring that the cancer has not
      returned and have not reviewed functional outcomes in enough detail. Because of this we are
      unsure exactly how common the problems described are.

      The proposed study will allow us to determine how many patients have ongoing symptoms
      following their surgery for rectal cancer. It will also allow us to use a newly developed
      scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK
      population, to ensure that it can accurately be used in the future to measure the problem and
      aid development of new therapies. An appreciation of the impact of symptoms on postoperative
      quality of life will encourage routine assessment of functional outcomes in clinical
      practice, allowing identification of patients who may benefit from treatment.
One of the main aims when carrying out surgery for rectal cancer is to avoid patients ending
      up with a permanent stoma. The current standard operation for resection of the rectum is an
      anterior resection. A large proportion of the patients undergoing this procedure develop
      anterior resection syndrome, with significant alteration of their bowel habit, including
      urgency, incontinence and unpredictability. Many definitions for this problem have been used
      and until recently there was no specifically designed tool for measuring it. There has never
      been a large scale study in the UK to tell us how common the problem is. A meta-analysis
      combining results from small studies show marked variation in the frequency of symptoms
      ranging from 285%, mainly because of the different methods of assessment used in the studies.

      The LARS score was recently developed by a research group in Denmark. Their results show that
      45.9% of patients had major LARS at 12 months following surgery. This is nearly half of all
      patients in their sample and clearly represents an important problem.

      Anterior resection syndrome is known to have a negative effect on quality of life. It is a
      multifactorial condition and is increased in patients have chemotherapy and radiotherapy.
      There are treatments available and also in development which may help patients. However in
      clinical practice, patients are not routinely asked about their functional outcome and the
      effect that these symptoms can have on patients' lives is often not discussed. The urgent
      need for further research into the longterm functional effects of treatments for cancer has
      been acknowledged by the National Institute for Health and Care Excellence (NICE) and the
      National Cancer Survivorship Initiative.

      Determining baseline prevalence in the UK and validating the LARS score will allow accurate
      preoperative counselling of patients about functional outcomes following surgery for rectal
      cancer. It will facilitate comparison between populations, further helping to determine risk
      factors and aiding in development of therapeutic interventions. An appreciation of the impact
      of anterior resection syndrome on postoperative quality of life will encourage routine
      assessment of functional outcomes in clinical practice, allowing identification of patients
      who may benefit from treatment.
time perspective: Cross-Sectional
measure: Number of participants with no LARS; minor LARS and major LARS
time frame: At the time of questionnaire completion
description: This will allow us to determine the prevalence of Low Anterior Resection Syndrome
measure: Correlation between LARS score and EORTC QLQ-C30 questionnaire score
time frame: At the time of questionnaire completion
description: The association between the LARS score and The European Organization for Research and Treatment of Cancer (EORTC) generic quality of life questionnaire QLQC30 will be used to establish validity of the LARS score. Ability of the score to differ between patient groups known to differ in postoperative function (for example, those who have had radiotherapy and those who have not) will also be used to assess validity.
measure: LARS score in different age groups
time frame: At time of questionnaire completion
measure: LARS score in participants who have had laparoscopic surgery and participants who have had open surgery
time frame: At time of questionnaire completion
arm group label: Anterior resection
description: Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohamed Thaha, PhD FRCS
role: Study Chair
affiliation: Queen Mary University of London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Rectal Neoplasms