<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/NCT02971332</url>
  </required_header>
  <id_info>
    <org_study_id>STR016a</org_study_id>
    <nct_id>NCT02971332</nct_id>
  </id_info>
  <brief_title>Long Term Results of STARR With Contour Transtar</brief_title>
  <acronym>LTSTARR</acronym>
  <official_title>STARR With Contour Transtar for Obstructed Defecation Syndrome: Long Term Results</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study&#xD;
      the investigators want to evaluate the long term results of Stapled Transanal Rectal&#xD;
      Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A&#xD;
      re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was&#xD;
      conducted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>degree of constipation</measure>
    <time_frame>6 months</time_frame>
    <description>Cleveland Clinic Constipation Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>degree of constipation</measure>
    <time_frame>5 years</time_frame>
    <description>Cleveland Clinic Constipation Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical Complications</measure>
    <time_frame>0-6 months</time_frame>
    <description>intraoperative and postoperative surgical complications</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Defecatory aids</measure>
    <time_frame>6 months</time_frame>
    <description>the use of laxatives or digitation to defecate</description>
  </other_outcome>
  <other_outcome>
    <measure>Defecatory aids</measure>
    <time_frame>5 years</time_frame>
    <description>the use of laxatives or digitation to defecate</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Rectal Prolapse</condition>
  <condition>Rectocele</condition>
  <condition>Intussusception of Rectum</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <description>Patients candidated to STARR after the failure of medical and dietary therapy and after a complete radiological and functional study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stapled Transanal Rectal Resection</intervention_name>
    <description>The prolapsed tissue is pulled out through the CAD using e gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected. Four to five parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, in order to control the tissue during resection. The prolapse is then opened longitudinally at 3 o'clock with the electric scalpel between two Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex.&#xD;
The longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise using an average of 4-6 recharges, with care to always place the stapler at the base of the prolapse. The resected specimen was always inspected before the end of the procedure.</description>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>STARR</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with symptomatic ODS after failure of medical and dietary therapy and with the&#xD;
        presence determined through cinedefecography of a rectocele that did not empty and/or a&#xD;
        recto-rectal or recto-anal intussusception, in the absence of anal sphincter contractile&#xD;
        deficiency&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ODS&#xD;
&#xD;
          -  presence of a rectocele that did not empty and/or a recto-rectal or recto-anal&#xD;
             intussusception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anal sphincter contractile deficiency&#xD;
&#xD;
          -  previous rectal resection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Francesco Saverio Mari, MD, PhD, FACS</investigator_full_name>
    <investigator_title>MD, PhD, FACS</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Prolapse</mesh_term>
    <mesh_term>Rectocele</mesh_term>
    <mesh_term>Intussusception</mesh_term>
    <mesh_term>Prolapse</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/NCT02971332
org study id: STR016a
nct id: NCT02971332
lead sponsor: 
has dmc: No
Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study
      the investigators want to evaluate the long term results of Stapled Transanal Rectal
      Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A
      re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was
      conducted.
observational model: Case-Only
time perspective: Prospective
measure: degree of constipation
time frame: 6 months
description: Cleveland Clinic Constipation Score
measure: degree of constipation
time frame: 5 years
description: Cleveland Clinic Constipation Score
measure: Surgical Complications
time frame: 0-6 months
description: intraoperative and postoperative surgical complications
measure: Defecatory aids
time frame: 6 months
description: the use of laxatives or digitation to defecate
measure: Defecatory aids
time frame: 5 years
description: the use of laxatives or digitation to defecate
arm group label: Treatment Group
description: Patients candidated to STARR after the failure of medical and dietary therapy and after a complete radiological and functional study.
intervention type: Procedure
intervention name: Stapled Transanal Rectal Resection
description: The prolapsed tissue is pulled out through the CAD using e gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected. Four to five parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, in order to control the tissue during resection. The prolapse is then opened longitudinally at 3 o'clock with the electric scalpel between two Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex.
The longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise using an average of 4-6 recharges, with care to always place the stapler at the base of the prolapse. The resected specimen was always inspected before the end of the procedure.
arm group label: Treatment Group
other name: STARR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Francesco Saverio Mari, MD, PhD, FACS
investigator title: MD, PhD, FACS
mesh term: Rectal Prolapse
mesh term: Rectocele
mesh term: Intussusception
mesh term: Prolapse
sharing ipd: No