<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/NCT04455945</url>
  </required_header>
  <id_info>
    <org_study_id>2017/514/108/12</org_study_id>
    <nct_id>NCT04455945</nct_id>
  </id_info>
  <brief_title>Quality of Life After Rectal Cancer Surgery</brief_title>
  <official_title>Comparison of Quality of Life Outcomes Between Laparoscopic and Open Approach for Rectal Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Lutfi Kirdar Kartal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Lutfi Kirdar Kartal Training and Research 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>
      Following colorectal surgery, many patients face a combination of physical and emotional&#xD;
      problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and&#xD;
      sexual function, as well as problems in social and role functioning, inevitably affect the&#xD;
      patients' well-being. Therefore, evaluation of the self-reported quality of life (QoL) is&#xD;
      becoming increasingly important in clinical trials. The investigators aimed to compare long&#xD;
      term health related life quality (HRQoL) results of laparoscopic approach with open approach&#xD;
      in patients with sphincter preserving resections for rectal cancer at a single-center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is planned prospectively. All patients scheduled for operation due to rectal&#xD;
      cancer in our clinic between January 2017 and December 2018 will be evaluated for suitability&#xD;
      for the study. During the preoperative examination, patients will be informed about the study&#xD;
      and their written consent will be obtained. Patients will be randomized between open and&#xD;
      laparoscopic groups in the ratio 2:1, depending on the type of surgery. Clinical data of&#xD;
      patients will be analyzed from the hospital database programme.&#xD;
&#xD;
      The EORTC QLQ-C30 and QLQ-CR29 questionnaires prepared by The European Organization for&#xD;
      Research and Treatment of Cancer (EORTC) will be used to evaluate the quality of life after&#xD;
      the operation. The EORTC QLQ-C30 questionnaire will be completed by examining the patients'&#xD;
      daily observation notes. EORTC QLQ-CR29 will be completed with face to face interviews in the&#xD;
      first year after surgery.&#xD;
&#xD;
      In this way, it will be aimed to compare the early and long-term quality of life (HRQoL)&#xD;
      results of open and laparoscopic approach in patients undergoing surgery for rectal cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">June 19, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Age</measure>
    <time_frame>Before surgery</time_frame>
    <description>Years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender</measure>
    <time_frame>Before surgery</time_frame>
    <description>Male/Female</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>Before surgery</time_frame>
    <description>kg/m²</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ASA</measure>
    <time_frame>Before surgery</time_frame>
    <description>I, II, III, IV</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor Localization</measure>
    <time_frame>During the operation</time_frame>
    <description>Upper/Middle/Low</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pathologic Stage</measure>
    <time_frame>up to 10 days after surgery</time_frame>
    <description>1A, 1B, 2A, 2B, 3A, 3B, 3C</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>yes/no</description>
  </primary_outcome>
  <primary_outcome>
    <measure>European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Functional scales</measure>
    <time_frame>During one week after surgery</time_frame>
    <description>Global/Physical/Role/Cognitive/Social functioning. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Symptom scales</measure>
    <time_frame>During one week after surgery</time_frame>
    <description>Fatigue/Nausea and vomiting/Pain/Dyspnoea/Insomnia/Appetite loss/Constipation/Diarrhoea/Financial difficulties. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Functional scales</measure>
    <time_frame>During one year after surgery</time_frame>
    <description>Body Image/Future projections/Weight/Sexual interest. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Symptom scales</measure>
    <time_frame>During one year after surgery</time_frame>
    <description>Urinary frequency/Blood and mucus in stool/Stool frequency/Urinary incontinence/Dysuria/Abdominal pain/Buttock pain/Bloating/Dry mouth/Hair loss/Taste/Flatulence/Faecal incontinence/Sore skin/Embarrassment/Impotence/Dyspareunia. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2</enrollment>
  <condition>Rectal Cancer</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Open</arm_group_label>
    <description>Patients with open surgery for rectal cancer planned in our department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic</arm_group_label>
    <description>Patients with laparoscopic surgery for rectal cancer planned in our department.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Rectal cancer surgery</intervention_name>
    <description>Open sphincter preserving surgery for rectal cancer</description>
    <arm_group_label>Open</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Rectal cancer surgery</intervention_name>
    <description>Laparoscopic sphincter preserving surgery for rectal cancer</description>
    <arm_group_label>Laparoscopic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who underwent surgery (laparoscopic or open) for rectal cancer in our&#xD;
        department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who underwent surgery (laparoscopic or open) for rectal cancer in our&#xD;
             department.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients whose all oncological treatments had not been completed at least 6 months&#xD;
             ago&#xD;
&#xD;
          -  The patients with ASA IV score&#xD;
&#xD;
          -  The patients with previous abdominal surgery&#xD;
&#xD;
          -  The patients who had developed major surgical complications (such as anastomosis&#xD;
             leakage, requiring re-laparotomy, evisceration)&#xD;
&#xD;
          -  The patients who underwent a new abdominal surgery except for stoma closure&#xD;
&#xD;
          -  The patients with local recurrence or distant metastases&#xD;
&#xD;
          -  The patients who still had a stoma&#xD;
&#xD;
          -  The patients who did not want to take part in the study&#xD;
&#xD;
          -  The patients who missed in the follow-up period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Selcuk Kaya, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kartal Dr. Lutfi Kirdar Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kartal Dr Lutfi Kirdar Tranining and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34890</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Andersson J, Angenete E, Gellerstedt M, Angeras U, Jess P, Rosenberg J, Furst A, Bonjer J, Haglind E. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial. Br J Surg. 2016 Nov;103(12):1746. doi: 10.1002/bjs.10280. Epub 2016 Jul 6. No abstract available.</citation>
    <PMID>27801927</PMID>
  </reference>
  <reference>
    <citation>D'Ambrosio G, Paganini AM, Balla A, Quaresima S, Ursi P, Bruzzone P, Picchetto A, Mattei FI, Lezoche E. Quality of life in non-early rectal cancer treated by neoadjuvant radio-chemotherapy and endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgery (TEM) versus laparoscopic total mesorectal excision. Surg Endosc. 2016 Feb;30(2):504-511. doi: 10.1007/s00464-015-4232-8. Epub 2015 Jun 5.</citation>
    <PMID>26045097</PMID>
  </reference>
  <reference>
    <citation>D'Ambrosio G, Picchetto A, Campo S, Palma R, Panetta C, De Laurentis F, La Rocca S, Lezoche E. Quality of life in patients with loco-regional rectal cancer after ELRR by TEM versus VLS TME after nChRT: long-term results. Surg Endosc. 2019 Mar;33(3):941-948. doi: 10.1007/s00464-018-6583-4. Epub 2018 Nov 12.</citation>
    <PMID>30421081</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. Lutfi Kirdar Kartal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ramazan Sari</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>rectal cancer surgery</keyword>
  <keyword>life quality</keyword>
  <keyword>questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04455945
org study id: 2017/514/108/12
nct id: NCT04455945
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Following colorectal surgery, many patients face a combination of physical and emotional
      problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and
      sexual function, as well as problems in social and role functioning, inevitably affect the
      patients' well-being. Therefore, evaluation of the self-reported quality of life (QoL) is
      becoming increasingly important in clinical trials. The investigators aimed to compare long
      term health related life quality (HRQoL) results of laparoscopic approach with open approach
      in patients with sphincter preserving resections for rectal cancer at a single-center.
This study is planned prospectively. All patients scheduled for operation due to rectal
      cancer in our clinic between January 2017 and December 2018 will be evaluated for suitability
      for the study. During the preoperative examination, patients will be informed about the study
      and their written consent will be obtained. Patients will be randomized between open and
      laparoscopic groups in the ratio 2:1, depending on the type of surgery. Clinical data of
      patients will be analyzed from the hospital database programme.

      The EORTC QLQ-C30 and QLQ-CR29 questionnaires prepared by The European Organization for
      Research and Treatment of Cancer (EORTC) will be used to evaluate the quality of life after
      the operation. The EORTC QLQ-C30 questionnaire will be completed by examining the patients'
      daily observation notes. EORTC QLQ-CR29 will be completed with face to face interviews in the
      first year after surgery.

      In this way, it will be aimed to compare the early and long-term quality of life (HRQoL)
      results of open and laparoscopic approach in patients undergoing surgery for rectal cancer.
observational model: Cohort
time perspective: Prospective
measure: Age
time frame: Before surgery
description: Years
measure: Gender
time frame: Before surgery
description: Male/Female
measure: BMI
time frame: Before surgery
description: kg/m²
measure: ASA
time frame: Before surgery
description: I, II, III, IV
measure: Tumor Localization
time frame: During the operation
description: Upper/Middle/Low
measure: Pathologic Stage
time frame: up to 10 days after surgery
description: 1A, 1B, 2A, 2B, 3A, 3B, 3C
measure: Complications
time frame: Through study completion, an average of 1 year
description: yes/no
measure: European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Functional scales
time frame: During one week after surgery
description: Global/Physical/Role/Cognitive/Social functioning. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning.
measure: European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Symptom scales
time frame: During one week after surgery
description: Fatigue/Nausea and vomiting/Pain/Dyspnoea/Insomnia/Appetite loss/Constipation/Diarrhoea/Financial difficulties. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level.
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Functional scales
time frame: During one year after surgery
description: Body Image/Future projections/Weight/Sexual interest. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning.
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Symptom scales
time frame: During one year after surgery
description: Urinary frequency/Blood and mucus in stool/Stool frequency/Urinary incontinence/Dysuria/Abdominal pain/Buttock pain/Bloating/Dry mouth/Hair loss/Taste/Flatulence/Faecal incontinence/Sore skin/Embarrassment/Impotence/Dyspareunia. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level.
arm group label: Open
description: Patients with open surgery for rectal cancer planned in our department.
arm group label: Laparoscopic
description: Patients with laparoscopic surgery for rectal cancer planned in our department.
intervention type: Procedure
intervention name: Open Rectal cancer surgery
description: Open sphincter preserving surgery for rectal cancer
arm group label: Open
intervention type: Procedure
intervention name: Laparoscopic Rectal cancer surgery
description: Laparoscopic sphincter preserving surgery for rectal cancer
arm group label: Laparoscopic
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Selcuk Kaya, MD
role: Study Chair
affiliation: Kartal Dr. Lutfi Kirdar Training and Research Hospital
facility: 
country: Turkey
citation: Andersson J, Angenete E, Gellerstedt M, Angeras U, Jess P, Rosenberg J, Furst A, Bonjer J, Haglind E. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial. Br J Surg. 2016 Nov;103(12):1746. doi: 10.1002/bjs.10280. Epub 2016 Jul 6. No abstract available.
PMID: 27801927
citation: D'Ambrosio G, Paganini AM, Balla A, Quaresima S, Ursi P, Bruzzone P, Picchetto A, Mattei FI, Lezoche E. Quality of life in non-early rectal cancer treated by neoadjuvant radio-chemotherapy and endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgery (TEM) versus laparoscopic total mesorectal excision. Surg Endosc. 2016 Feb;30(2):504-511. doi: 10.1007/s00464-015-4232-8. Epub 2015 Jun 5.
PMID: 26045097
citation: D'Ambrosio G, Picchetto A, Campo S, Palma R, Panetta C, De Laurentis F, La Rocca S, Lezoche E. Quality of life in patients with loco-regional rectal cancer after ELRR by TEM versus VLS TME after nChRT: long-term results. Surg Endosc. 2019 Mar;33(3):941-948. doi: 10.1007/s00464-018-6583-4. Epub 2018 Nov 12.
PMID: 30421081
responsible party type: Principal Investigator
investigator affiliation: Dr. Lutfi Kirdar Kartal Training and Research Hospital
investigator full name: Ramazan Sari
investigator title: Principal Investigator
mesh term: Rectal Neoplasms
sharing ipd: No