<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/NCT03765411</url>
  </required_header>
  <id_info>
    <org_study_id>Robotic Proct in the Elderly</org_study_id>
    <nct_id>NCT03765411</nct_id>
  </id_info>
  <brief_title>Safe Colorectal Surgery in the Elderly</brief_title>
  <official_title>Safe Surgery in the Elderly: A Review of Outcomes Following Robotic Proctectomy From the Nationwide Inpatient Sample, a Retrospective Cross Sectional Cohort Study. Cross-Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tripler Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Madigan Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Tripler Army Medical Center</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>
      The objective was to evaluate the use and outcomes of robotic proctectomy compared to open&#xD;
      and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional&#xD;
      cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective was to evaluate the use and outcomes of robotic proctectomy compared to open&#xD;
      and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional&#xD;
      cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All&#xD;
      cases were restricted to age 70 years old or greater. The incidence of robotic proctectomy&#xD;
      from 2006 - 2013 both as a whole as well as divided into approach was analyzed. Each approach&#xD;
      was compared for both primary and secondary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">April 15, 2017</completion_date>
  <primary_completion_date type="Actual">April 15, 2013</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>In-hospital Complications</measure>
    <time_frame>through study completion, an average of 5 days</time_frame>
    <description>Complications to include mechanical wound, infections, urinary, pulmonary, gastrointestinal, cardiovascular, systemic, surgical, and any complication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>through study completion, an average of 5 days</time_frame>
    <description>Death during admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>through study completion, an average of 5 days</time_frame>
    <description>Length of in hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs and Charges</measure>
    <time_frame>through study completion, an average of 5 days</time_frame>
    <description>Hospital charges refer to the total amount billed by the hospital. Hospital cost refers to the amount paid by the insurance provider</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">6740</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Open Proctectomy Patients</arm_group_label>
    <description>Patients who underwent Proctectomy through an open approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic Proctectomy Patients</arm_group_label>
    <description>Patients who underwent Proctectomy through a Laparoscopic approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic Proctectomy Patients</arm_group_label>
    <description>Patients who underwent Proctectomy through a Robotic approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Proctectomy</intervention_name>
    <description>Resection of the rectum</description>
    <arm_group_label>Laparoscopic Proctectomy Patients</arm_group_label>
    <arm_group_label>Open Proctectomy Patients</arm_group_label>
    <arm_group_label>Robotic Proctectomy Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were eligible if they were 70 years old or greater, underwent proctectomy in an&#xD;
        elective setting, and did not have an abdominoperioneal resection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  70 years of age or older&#xD;
&#xD;
          -  underwent proctectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergent admissions&#xD;
&#xD;
          -  abdominoperineal resections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Tripler Army Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96859</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.census.gov/content/dam/Census/library/publications/2016/demo/p95-16-1.pdf</url>
    <description>An Aging World: 2015 International Population Reports</description>
  </link>
  <results_reference>
    <citation>Guiding principles for the care of older adults with multimorbidity: an approach for clinicians. Guiding principles for the care of older adults with multimorbidity: an approach for clinicians: American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity. J Am Geriatr Soc. 2012 Oct;60(10):E1-E25. doi: 10.1111/j.1532-5415.2012.04188.x. Epub 2012 Sep 19. No abstract available.</citation>
    <PMID>22994865</PMID>
  </results_reference>
  <results_reference>
    <citation>Fielding LP, Phillips RK, Hittinger R. Factors influencing mortality after curative resection for large bowel cancer in elderly patients. Lancet. 1989 Mar 18;1(8638):595-7. doi: 10.1016/s0140-6736(89)91618-8.</citation>
    <PMID>2564119</PMID>
  </results_reference>
  <results_reference>
    <citation>Tan KY, Kawamura Y, Mizokami K, Sasaki J, Tsujinaka S, Maeda T, Konishi F. Colorectal surgery in octogenarian patients--outcomes and predictors of morbidity. Int J Colorectal Dis. 2009 Feb;24(2):185-9. doi: 10.1007/s00384-008-0615-9. Epub 2008 Dec 3.</citation>
    <PMID>19050901</PMID>
  </results_reference>
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    <PMID>12495308</PMID>
  </results_reference>
  <results_reference>
    <citation>Cheung HY, Chung CC, Fung JT, Wong JC, Yau KK, Li MK. Laparoscopic resection for colorectal cancer in octogenarians: results in a decade. Dis Colon Rectum. 2007 Nov;50(11):1905-10. doi: 10.1007/s10350-007-9070-x. Epub 2007 Sep 26.</citation>
    <PMID>17899275</PMID>
  </results_reference>
  <results_reference>
    <citation>Stocchi L, Nelson H, Young-Fadok TM, Larson DR, Ilstrup DM. Safety and advantages of laparoscopic vs. open colectomy in the elderly: matched-control study. Dis Colon Rectum. 2000 Mar;43(3):326-32. doi: 10.1007/BF02258297.</citation>
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  </results_reference>
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    <citation>Vignali A, Di Palo S, Tamburini A, Radaelli G, Orsenigo E, Staudacher C. Laparoscopic vs. open colectomies in octogenarians: a case-matched control study. Dis Colon Rectum. 2005 Nov;48(11):2070-5. doi: 10.1007/s10350-005-0147-0.</citation>
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    <PMID>20011205</PMID>
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  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tripler Army Medical Center</investigator_affiliation>
    <investigator_full_name>Carly R Richards</investigator_full_name>
    <investigator_title>General Surgery Chief Resident Surgeon</investigator_title>
  </responsible_party>
  <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>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/NCT03765411
org study id: Robotic Proct in the Elderly
nct id: NCT03765411
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective was to evaluate the use and outcomes of robotic proctectomy compared to open
      and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional
      cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed.
The objective was to evaluate the use and outcomes of robotic proctectomy compared to open
      and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional
      cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All
      cases were restricted to age 70 years old or greater. The incidence of robotic proctectomy
      from 2006 - 2013 both as a whole as well as divided into approach was analyzed. Each approach
      was compared for both primary and secondary outcomes.
observational model: Case-Only
time perspective: Cross-Sectional
measure: In-hospital Complications
time frame: through study completion, an average of 5 days
description: Complications to include mechanical wound, infections, urinary, pulmonary, gastrointestinal, cardiovascular, systemic, surgical, and any complication
measure: In-hospital mortality
time frame: through study completion, an average of 5 days
description: Death during admission
measure: Length of Stay
time frame: through study completion, an average of 5 days
description: Length of in hospital stay
measure: Costs and Charges
time frame: through study completion, an average of 5 days
description: Hospital charges refer to the total amount billed by the hospital. Hospital cost refers to the amount paid by the insurance provider
arm group label: Open Proctectomy Patients
description: Patients who underwent Proctectomy through an open approach
arm group label: Laparoscopic Proctectomy Patients
description: Patients who underwent Proctectomy through a Laparoscopic approach
arm group label: Robotic Proctectomy Patients
description: Patients who underwent Proctectomy through a Robotic approach
intervention type: Procedure
intervention name: Proctectomy
description: Resection of the rectum
arm group label: Laparoscopic Proctectomy Patients
arm group label: Open Proctectomy Patients
arm group label: Robotic Proctectomy Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
facility: 
country: United States
url: https://www.census.gov/content/dam/Census/library/publications/2016/demo/p95-16-1.pdf
description: An Aging World: 2015 International Population Reports
citation: Guiding principles for the care of older adults with multimorbidity: an approach for clinicians. Guiding principles for the care of older adults with multimorbidity: an approach for clinicians: American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity. J Am Geriatr Soc. 2012 Oct;60(10):E1-E25. doi: 10.1111/j.1532-5415.2012.04188.x. Epub 2012 Sep 19. No abstract available.
PMID: 22994865
citation: Fielding LP, Phillips RK, Hittinger R. Factors influencing mortality after curative resection for large bowel cancer in elderly patients. Lancet. 1989 Mar 18;1(8638):595-7. doi: 10.1016/s0140-6736(89)91618-8.
PMID: 2564119
citation: Tan KY, Kawamura Y, Mizokami K, Sasaki J, Tsujinaka S, Maeda T, Konishi F. Colorectal surgery in octogenarian patients--outcomes and predictors of morbidity. Int J Colorectal Dis. 2009 Feb;24(2):185-9. doi: 10.1007/s00384-008-0615-9. Epub 2008 Dec 3.
PMID: 19050901
citation: Law WL, Chu KW, Tung PH. Laparoscopic colorectal resection: a safe option for elderly patients. J Am Coll Surg. 2002 Dec;195(6):768-73. doi: 10.1016/s1072-7515(02)01483-7.
PMID: 12495308
citation: Cheung HY, Chung CC, Fung JT, Wong JC, Yau KK, Li MK. Laparoscopic resection for colorectal cancer in octogenarians: results in a decade. Dis Colon Rectum. 2007 Nov;50(11):1905-10. doi: 10.1007/s10350-007-9070-x. Epub 2007 Sep 26.
PMID: 17899275
citation: Stocchi L, Nelson H, Young-Fadok TM, Larson DR, Ilstrup DM. Safety and advantages of laparoscopic vs. open colectomy in the elderly: matched-control study. Dis Colon Rectum. 2000 Mar;43(3):326-32. doi: 10.1007/BF02258297.
PMID: 10733113
citation: Vignali A, Di Palo S, Tamburini A, Radaelli G, Orsenigo E, Staudacher C. Laparoscopic vs. open colectomies in octogenarians: a case-matched control study. Dis Colon Rectum. 2005 Nov;48(11):2070-5. doi: 10.1007/s10350-005-0147-0.
PMID: 16086219
citation: Champagne BJ, Delaney CP. Laparoscopic approaches to rectal cancer. Clin Colon Rectal Surg. 2007 Aug;20(3):237-48. doi: 10.1055/s-2007-984868.
PMID: 20011205
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responsible party type: Principal Investigator
investigator affiliation: Tripler Army Medical Center
investigator full name: Carly R Richards
investigator title: General Surgery Chief Resident Surgeon
mesh term: Rectal Neoplasms
sharing ipd: Undecided