xml: <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/NCT06009133</url>
    </required_header>
    <id_info>
      <org_study_id>Konya HH Group</org_study_id>
      <nct_id>NCT06009133</nct_id>
    </id_info>
    <brief_title>Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease</brief_title>
    <official_title>Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Konya Meram State Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Konya Meram State 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>
        Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications&#xD;
        of hemorrhoidal disease that results in pain and loss of work force. Although surgical&#xD;
        excision is recommended in the treatment of AETHH in the guidelines of the American Society&#xD;
        of Colorectal Surgeons (ASCRS) and the European Society of Coloproctology (ESCP), the level&#xD;
        of evidence is low and it is emphasized that additional studies are needed. Therefore, the&#xD;
        investigators aimed to compare the efficacy of surgical excision with medical treatment in&#xD;
        the treatment of AETHH.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hemorrhoids are normal anatomical structures and are divided into internal and external&#xD;
        according to the dentate line. External hemorrhoids distal to the dentate line, unlike&#xD;
        internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic&#xD;
        innervation, and are highly sensitive to pain.&#xD;
  &#xD;
        While internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal&#xD;
        prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless&#xD;
        thrombosed. Acute constipation or excessive straining are held responsible for acute external&#xD;
        thrombosed hemorrhoidal disease (AETHD). It appears as a painful, firm, purple-colored mass&#xD;
        in the anoderm, and the main symptom is anal pain. The severity of pain increases in the&#xD;
        first 24-48 hours after the formation of the thrombosed pack and reaches its peak. The pain&#xD;
        is quite severe in the first 72-96 hours. Afterwards, with the resorption of the thrombosis,&#xD;
        the severity of the pain decreases and the disease heals, leaving a skin tag behind.&#xD;
  &#xD;
        AETHD can be treated with surgical excision or conservative approaches. Conservative&#xD;
        treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. Also,&#xD;
        phlebotonic drugs can be added. In the ASCRS and ESCP guidelines, early surgical excision is&#xD;
        recommended for patients with acute external thrombosed hemorrhoidal disease in the first&#xD;
        72-96 hours (low quality evidence 2C). Guidelines highlight the lack of controlled studies of&#xD;
        AETHD treatment .&#xD;
  &#xD;
        In this study, the investigators aimed to compare early surgical excision with conservative&#xD;
        treatment in terms of pain control and recurrence in the treatment of AETHD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Actual">March 14, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pain score with visual analog scale</measure>
      <time_frame>12 hours</time_frame>
      <description>The participants pain at the 12th hour postoperatively was scored with a visual analog scale. The visual analog scale was between 0 and 10 mm. 0 rated as no pain, 10 as very severe pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to return to daily activities</measure>
      <time_frame>15 days</time_frame>
      <description>The patients' return to daily activities were recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence</measure>
      <time_frame>6 months</time_frame>
      <description>It was recorded whether the patients had hemorrhoid recurrence at 6 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction survey</measure>
      <time_frame>6 months</time_frame>
      <description>The satisfaction level of the participants was scored on a visual analog scale six months after the treatment. The visual analog scale was between 0 and 10 mm. 0 was rated as not at all satisfied, and 10 was rated as very satisfied.&#xD;
  Satisfaction questionnaire was applied to the patients at 6 months.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">132</enrollment>
    <condition>Hemorrhoids External Thrombosed</condition>
    <arm_group>
      <arm_group_label>Conservative Treatment Group</arm_group_label>
      <description>Micronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month.&#xD;
  Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Surgical Treatment Group</arm_group_label>
      <description>While the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conservative treatment</intervention_name>
      <description>Micronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month.&#xD;
  Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.</description>
      <arm_group_label>Conservative Treatment Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Surgical Treatment</intervention_name>
      <description>While the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group.</description>
      <arm_group_label>Surgical Treatment Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The population of the study consisted of patients who applied to the general surgery&#xD;
          outpatient clinic due to acute external thrombosed hemorrhoids disease. Patients who fully&#xD;
          met the inclusion criteria and did not meet the exclusion criteria constituted the sample&#xD;
          group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between the ages of 18-70 who present with isolated external thrombosed&#xD;
               hemorrhoids&#xD;
  &#xD;
            -  Patients with the onset of the complaint before 96 hours&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients under the age of 18 and patients over the age of 70&#xD;
  &#xD;
            -  Mentally retarded patients&#xD;
  &#xD;
            -  Pregnant patients&#xD;
  &#xD;
            -  Patients with concomitant proctological disorders (anal fissure, anal fistula, anal&#xD;
               abscess, etc.)&#xD;
  &#xD;
          Those with a history of proctology surgery&#xD;
  &#xD;
            -  Patients with grade 3-4 internal hemorrhoids&#xD;
  &#xD;
            -  Patients using anticoagulant drugs&#xD;
  &#xD;
            -  Patients whose complaint has passed 96 hours after onset&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hasan Yaldız, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Konya City Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Konya Training and Research Hospital</name>
        <address>
          <city>Konya</city>
          <zip>42090</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Konya Meram State Hospital</investigator_affiliation>
      <investigator_full_name>Alpaslan Şahin</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhoids</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009133
  org study id: Konya HH Group
  nct id: NCT06009133
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications
        of hemorrhoidal disease that results in pain and loss of work force. Although surgical
        excision is recommended in the treatment of AETHH in the guidelines of the American Society
        of Colorectal Surgeons (ASCRS) and the European Society of Coloproctology (ESCP), the level
        of evidence is low and it is emphasized that additional studies are needed. Therefore, the
        investigators aimed to compare the efficacy of surgical excision with medical treatment in
        the treatment of AETHH.
  Hemorrhoids are normal anatomical structures and are divided into internal and external
        according to the dentate line. External hemorrhoids distal to the dentate line, unlike
        internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic
        innervation, and are highly sensitive to pain.
  
        While internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal
        prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless
        thrombosed. Acute constipation or excessive straining are held responsible for acute external
        thrombosed hemorrhoidal disease (AETHD). It appears as a painful, firm, purple-colored mass
        in the anoderm, and the main symptom is anal pain. The severity of pain increases in the
        first 24-48 hours after the formation of the thrombosed pack and reaches its peak. The pain
        is quite severe in the first 72-96 hours. Afterwards, with the resorption of the thrombosis,
        the severity of the pain decreases and the disease heals, leaving a skin tag behind.
  
        AETHD can be treated with surgical excision or conservative approaches. Conservative
        treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. Also,
        phlebotonic drugs can be added. In the ASCRS and ESCP guidelines, early surgical excision is
        recommended for patients with acute external thrombosed hemorrhoidal disease in the first
        72-96 hours (low quality evidence 2C). Guidelines highlight the lack of controlled studies of
        AETHD treatment .
  
        In this study, the investigators aimed to compare early surgical excision with conservative
        treatment in terms of pain control and recurrence in the treatment of AETHD.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Pain score with visual analog scale
  time frame: 12 hours
  description: The participants pain at the 12th hour postoperatively was scored with a visual analog scale. The visual analog scale was between 0 and 10 mm. 0 rated as no pain, 10 as very severe pain.
  measure: Time to return to daily activities
  time frame: 15 days
  description: The patients' return to daily activities were recorded.
  measure: Recurrence
  time frame: 6 months
  description: It was recorded whether the patients had hemorrhoid recurrence at 6 months.
  measure: Satisfaction survey
  time frame: 6 months
  description: The satisfaction level of the participants was scored on a visual analog scale six months after the treatment. The visual analog scale was between 0 and 10 mm. 0 was rated as not at all satisfied, and 10 was rated as very satisfied.
  Satisfaction questionnaire was applied to the patients at 6 months.
  arm group label: Conservative Treatment Group
  description: Micronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month.
  Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.
  arm group label: Surgical Treatment Group
  description: While the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group.
  intervention type: Procedure
  intervention name: Conservative treatment
  description: Micronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month.
  Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.
  arm group label: Conservative Treatment Group
  intervention type: Procedure
  intervention name: Surgical Treatment
  description: While the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group.
  arm group label: Surgical Treatment Group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Hasan Yaldız, MD
  role: Principal Investigator
  affiliation: Konya City Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Konya Meram State Hospital
  investigator full name: Alpaslan Şahin
  investigator title: Principle Investigator
  mesh term: Hemorrhoids