<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/NCT03245086</url>
  </required_header>
  <id_info>
    <org_study_id>934287</org_study_id>
    <nct_id>NCT03245086</nct_id>
  </id_info>
  <brief_title>Multicenter Prospective Trial on Hemorrhoids</brief_title>
  <official_title>Multi-center, Non-randomized Prospective Observation Study Comparing Ferguson Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization (THD) for Prolapsed, Nonincarcerated, Reducible Hemorrhoids in Terms of 1-year Recurrence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>THD America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare Ferguson hemorrhoidectomy and THD in terms of one-year recurrence in&#xD;
      a large population (N=492). Recurrence is defined as prolapsing internal hemorrhoids at&#xD;
      physical examination performed by a colorectal surgeon.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, parallel arm, non-randomized prospective data collection trial&#xD;
      comparing Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. All&#xD;
      subjects will already be scheduled for either Ferguson or THD hemorrhoidectomy, the surgery&#xD;
      is NOT part of the research. Although a randomized study would control for variation among&#xD;
      surgeons, this study design provides the best patient safety since the surgeons will perform&#xD;
      the technique they do most frequently. Variability in the patient population will be managed&#xD;
      with a conservative sample size, which allows for a multivariate analysis of the sample&#xD;
      populations if any confounding variables are noted during initial data analyses. In addition,&#xD;
      the variability will be minimized with stringent and detailed inclusion/exclusion criteria in&#xD;
      terms of hemorrhoidal disease. Patients will be enrolled and followed for one year.&#xD;
      Participating surgeons will be credentialed and each participating surgeon will enroll up to&#xD;
      ten consecutive patients.&#xD;
&#xD;
      The primary endpoint of this study is to compare Ferguson hemorrhoidectomy and THD in terms&#xD;
      of recurrence rates at one-year. Recurrence is defined as prolapsing internal hemorrhoids at&#xD;
      physical examination performed by a colorectal surgeon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 17, 2016</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>1-year recurrence rates</measure>
    <time_frame>1-year</time_frame>
    <description>The primary endpoint of this study is to compare Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. Recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>30 days</time_frame>
    <description>The secondary outcomes include postoperative complications (i.e. urinary retention, constipation, dysuria, pruritis ani, anal pain, anal stenosis, unhealed wound, fissure, fecal urgency, incontinence- flatus, incontinence- stool)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">492</enrollment>
  <condition>Hemorrhoids</condition>
  <arm_group>
    <arm_group_label>Transanal hemorrhoid dearterialization (THD)</arm_group_label>
    <description>Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing transanal hemorrhoid dearterialization (THD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferguson hemorrhoidectomy</arm_group_label>
    <description>Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing Ferguson hemorrhoidectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transanal hemorrhoid dearterialization</intervention_name>
    <description>The hemorrhoids are operated in their natural position and not distorted by eversion The proctoscope is fully introduced transanally to reach the lower rectum. Under Doppler guidance, six arterial signals are found circumferentially above the dentate line. The approach to make the 'dearterialization' involves the transfixation of the rectal mucosa and submucosa to entrap the artery using a suture. Mucopexy is performed after the artery ligation with the same suture used for the dearterialization. Finally, the suture is tied to fix the mucopexy.</description>
    <arm_group_label>Transanal hemorrhoid dearterialization (THD)</arm_group_label>
    <other_name>THD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ferguson hemorrhoidectomy</intervention_name>
    <description>The hemorrhoids are operated in their natural position and not distorted by eversion. A Ferguson-Hill retractor is used to expose the hemorrhoids. Dissection with scissors is directed up to the dentate line where the fibers of the sphincter muscles are exposed and only a mucosal pedicle remains attached. A Buie-Smith crushing clamp is applied to this pedicle and the hemorrhoidal mass is excised at the superior level of the clamp. The pedicle is then ligated and the crushing clamp is removed. After dissection of the intermuscular septum is complete, the margins of the wound are drawn upward into the anal canal with stitches and are secured to the pedicle by the same suture. The remainder of the wound is closed with a stitch tied at the outer extremity of the wound using the same suture.</description>
    <arm_group_label>Ferguson hemorrhoidectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3&#xD;
        columns at physical examination and scheduled for either Ferguson or THD hemorrhoidectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient must be:&#xD;
&#xD;
          -  At least 18 years-old&#xD;
&#xD;
          -  Able to sign informed consent&#xD;
&#xD;
          -  Presenting with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3&#xD;
             columns at physical examination and scheduled for either Ferguson or THD&#xD;
             hemorrhoidectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any prior anorectal surgery except for conventional office-based interventions (rubber&#xD;
             band ligation, sclerotherapy, and infrared coagulation)&#xD;
&#xD;
          -  Prior pelvic radiotherapy&#xD;
&#xD;
          -  Inflammatory bowel diseases&#xD;
&#xD;
          -  Pre-existing fecal incontinence (Wexner score5 ≥8)&#xD;
&#xD;
          -  Pre-existing chronic anal diseases&#xD;
&#xD;
          -  Grades III and IV gynecological and obstetrical trauma per medical history and/or&#xD;
             physical examination&#xD;
&#xD;
          -  Connective tissue disorders&#xD;
&#xD;
          -  Subject is pregnant&#xD;
&#xD;
          -  Subject is under incarceration&#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>George Angelos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stony Brook University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suresh Yelika, MD</last_name>
    <phone>631-638-2215</phone>
    <email>suresh.yelika@stonybrookmedicine.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mahir Gachabayov, MD</last_name>
    <email>gachabayovmahir@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suresh Yelika, MD</last_name>
      <phone>631-638-2215</phone>
      <email>suresh.yelika@stonybrookmedicine.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mahir Gachabayov, MD</last_name>
      <email>gachabayovmahir@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>FERGUSON JA, HEATON JR. Closed hemorrhoidectomy. Dis Colon Rectum. 1959 Mar-Apr;2(2):176-9. doi: 10.1007/BF02616713. No abstract available.</citation>
    <PMID>13652788</PMID>
  </reference>
  <reference>
    <citation>Ratto C, Parello A, Veronese E, Cudazzo E, D'Agostino E, Pagano C, Cavazzoni E, Brugnano L, Litta F. Doppler-guided transanal haemorrhoidal dearterialization for haemorrhoids: results from a multicentre trial. Colorectal Dis. 2015 Jan;17(1):O10-9. doi: 10.1111/codi.12779.</citation>
    <PMID>25213152</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stony Brook University</investigator_affiliation>
    <investigator_full_name>George Angelos</investigator_full_name>
    <investigator_title>George Angelos, MD, MS</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be available to other researchers.</ipd_description>
  </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/NCT03245086
org study id: 934287
nct id: NCT03245086
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will compare Ferguson hemorrhoidectomy and THD in terms of one-year recurrence in
      a large population (N=492). Recurrence is defined as prolapsing internal hemorrhoids at
      physical examination performed by a colorectal surgeon.
This is a multicenter, parallel arm, non-randomized prospective data collection trial
      comparing Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. All
      subjects will already be scheduled for either Ferguson or THD hemorrhoidectomy, the surgery
      is NOT part of the research. Although a randomized study would control for variation among
      surgeons, this study design provides the best patient safety since the surgeons will perform
      the technique they do most frequently. Variability in the patient population will be managed
      with a conservative sample size, which allows for a multivariate analysis of the sample
      populations if any confounding variables are noted during initial data analyses. In addition,
      the variability will be minimized with stringent and detailed inclusion/exclusion criteria in
      terms of hemorrhoidal disease. Patients will be enrolled and followed for one year.
      Participating surgeons will be credentialed and each participating surgeon will enroll up to
      ten consecutive patients.

      The primary endpoint of this study is to compare Ferguson hemorrhoidectomy and THD in terms
      of recurrence rates at one-year. Recurrence is defined as prolapsing internal hemorrhoids at
      physical examination performed by a colorectal surgeon.
observational model: Case-Control
time perspective: Prospective
measure: 1-year recurrence rates
time frame: 1-year
description: The primary endpoint of this study is to compare Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. Recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.
measure: Postoperative complications
time frame: 30 days
description: The secondary outcomes include postoperative complications (i.e. urinary retention, constipation, dysuria, pruritis ani, anal pain, anal stenosis, unhealed wound, fissure, fecal urgency, incontinence- flatus, incontinence- stool)
arm group label: Transanal hemorrhoid dearterialization (THD)
description: Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing transanal hemorrhoid dearterialization (THD).
arm group label: Ferguson hemorrhoidectomy
description: Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing Ferguson hemorrhoidectomy.
intervention type: Device
intervention name: Transanal hemorrhoid dearterialization
description: The hemorrhoids are operated in their natural position and not distorted by eversion The proctoscope is fully introduced transanally to reach the lower rectum. Under Doppler guidance, six arterial signals are found circumferentially above the dentate line. The approach to make the 'dearterialization' involves the transfixation of the rectal mucosa and submucosa to entrap the artery using a suture. Mucopexy is performed after the artery ligation with the same suture used for the dearterialization. Finally, the suture is tied to fix the mucopexy.
arm group label: Transanal hemorrhoid dearterialization (THD)
other name: THD
intervention type: Procedure
intervention name: Ferguson hemorrhoidectomy
description: The hemorrhoids are operated in their natural position and not distorted by eversion. A Ferguson-Hill retractor is used to expose the hemorrhoids. Dissection with scissors is directed up to the dentate line where the fibers of the sphincter muscles are exposed and only a mucosal pedicle remains attached. A Buie-Smith crushing clamp is applied to this pedicle and the hemorrhoidal mass is excised at the superior level of the clamp. The pedicle is then ligated and the crushing clamp is removed. After dissection of the intermuscular septum is complete, the margins of the wound are drawn upward into the anal canal with stitches and are secured to the pedicle by the same suture. The remainder of the wound is closed with a stitch tied at the outer extremity of the wound using the same suture.
arm group label: Ferguson hemorrhoidectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Angelos, MD
role: Principal Investigator
affiliation: Stony Brook University
last name: Suresh Yelika, MD
phone: 631-638-2215
email: suresh.yelika@stonybrookmedicine.edu
last name: Mahir Gachabayov, MD
email: gachabayovmahir@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: FERGUSON JA, HEATON JR. Closed hemorrhoidectomy. Dis Colon Rectum. 1959 Mar-Apr;2(2):176-9. doi: 10.1007/BF02616713. No abstract available.
PMID: 13652788
citation: Ratto C, Parello A, Veronese E, Cudazzo E, D'Agostino E, Pagano C, Cavazzoni E, Brugnano L, Litta F. Doppler-guided transanal haemorrhoidal dearterialization for haemorrhoids: results from a multicentre trial. Colorectal Dis. 2015 Jan;17(1):O10-9. doi: 10.1111/codi.12779.
PMID: 25213152
responsible party type: Principal Investigator
investigator affiliation: Stony Brook University
investigator full name: George Angelos
investigator title: George Angelos, MD, MS
mesh term: Hemorrhoids
sharing ipd: No
ipd description: IPD will not be available to other researchers.