<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/NCT02216305</url>
  </required_header>
  <id_info>
    <org_study_id>HAL-RAR Plató 2.0</org_study_id>
    <nct_id>NCT02216305</nct_id>
  </id_info>
  <brief_title>HAL-RAR Versus Hemorrhoidectomy in the Treatment of Grade III-IV Hemorrhoids. Prospective, Randomized Trial</brief_title>
  <official_title>Prospective and Randomized Trial Comparing Doppler-Guided Transanal Hemorrhoid Artery Ligation With Recto-anal Repair (HAL-RAR) Versus Excisional Hemorrhoidectomy for the Treatment of Grade III-IV Hemorrhoids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Plató</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Plató</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      HYPOTHESIS&#xD;
&#xD;
        1. HAL- RAR causes a lower immediate postoperative pain compared with excision&#xD;
           hemorrhoidectomy.&#xD;
&#xD;
        2. HAL - RAR achieves similar immediate and long term results compared to the excision&#xD;
           hemorrhoidectomy in the control of hemorrhoidal symptoms.&#xD;
&#xD;
        3. The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
        1. Compare postoperative pain of both techniques.&#xD;
&#xD;
        2. Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique,&#xD;
           and compare the results with those of the excision hemorrhoidectomy.&#xD;
&#xD;
        3. Evaluate and compare the rate of complications of both techniques.&#xD;
&#xD;
        4. Assess the quality of life of patients before and after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The classic surgical treatment of hemorrhoidal disease is the excisional hemorrhoidectomy,&#xD;
      that consist in the surgical removal of one or more hemorrhoidal cushion, it is considered a&#xD;
      safe, radical and definitive treatment; however, it is not exempt of complications and the&#xD;
      postoperative pain is considerable. During the last two decades the concept of treatment has&#xD;
      evolved to control hemorrhoidal symptoms with less invasive techniques, such as hemorrhoidal&#xD;
      bands, arterial ligation Doppler guided hemorrhoidal and more recently, the association of&#xD;
      anorectal repair or mucopexia for treating hemorrhoidal mucosal prolapse .&#xD;
&#xD;
      MATERIAL AND METHODS&#xD;
&#xD;
      The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació&#xD;
      Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation).&#xD;
&#xD;
      All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with&#xD;
      both methods who agree to participate in the study, will be included in the prospective&#xD;
      randomized trial. All patients will be required to sign the specific informed consent.&#xD;
&#xD;
      Patients who are suitable for treatment with both techniques will be randomly assigned to the&#xD;
      surgical technique.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      1. Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or&#xD;
      prolapse) that are eligible for surgical treatment with both methods.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure,&#xD;
           perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal&#xD;
           stenosis.&#xD;
&#xD;
        2. Prior anorectal surgery .&#xD;
&#xD;
        3. Systemic pathology that could alter the outcome of the surgery as coagulopathies,&#xD;
           chronic pain with continued consumption of analgesics.&#xD;
&#xD;
        4. Age younger than 18 or older than 80 years, socio-pathology or inability to understand&#xD;
           the study objectives.&#xD;
&#xD;
      All surgeries are performed on an outpatient basis under regional anesthesia and sedation for&#xD;
      the same team of three surgeons. Preoperative preparation consists of a cleansing enema and&#xD;
      no prophylactic antibiotics will be administered.&#xD;
&#xD;
      Both techniques will be performed in &quot;Jack -Knife&quot; position. The open hemorrhoidectomy may&#xD;
      include one to three anal cushions and made according to the Milligan-Morgan technique, with&#xD;
      resection of the anal cushion and the external hemorrhoidal epidermal component using&#xD;
      electrocautery and ligation of the hemorrhoidal base with absorbable suture. Once completed&#xD;
      hemorrhoidectomy a perianal block is performed with bupivacaine/epinephrine.&#xD;
&#xD;
      Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally&#xD;
      invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the&#xD;
      superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the&#xD;
      blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently,&#xD;
      a running suture was added from the suture point to 5 mm above the dentate line to lift the&#xD;
      prolapsing hemorroid. Other procedures will not be associated, if necessary, the patient will&#xD;
      be excluded from the study .&#xD;
&#xD;
      The patient will be discharged if adequate pain control, oral tolerance and spontaneous&#xD;
      diuresis is achieved, and after examination by the surgeon in order to discard immediate&#xD;
      complications. The ambulatory treatment consists of an osmotic laxative (magnesium hydroxide&#xD;
      ), oral analgesia with paracetamol/tramadol ( 325mg/37.5mg ) every 6 hours and Dexketoprofen&#xD;
      (25 mg) every 8 hours, metamizol (575 mg) may be associated every 8 hours if pain. In case of&#xD;
      persistent pain, the patient will be examined in emergency room.&#xD;
&#xD;
      EVALUATION OF RESULTS A power analysis was performed to assess the study sample size.&#xD;
      Choosing a power of 0.8 and a confidence interval of 95% α-error of 0.05, we calculated that&#xD;
      20 patients were needed in each arm.&#xD;
&#xD;
      All patients will be evaluated with a validated questionnaire of 36 questions on quality of&#xD;
      life ( SF-36 ) and specific questions about specific symptoms of hemorrhoidal disease (pain,&#xD;
      itching , bleeding, soiling and hemorrhoidal prolapse reduction ). The questionnaire will be&#xD;
      answered before the intervention, after six and twelve months of follow up.&#xD;
&#xD;
      All patients will complete a diary testing global postoperative pain every day, measured on a&#xD;
      numerical scale from 0 to 10 during the first 15 days.&#xD;
&#xD;
      The patients will be assessed on the day of discharge and at 7, 14, and 30 postoperative&#xD;
      days. The patients will be evaluated at 6, 12 and 24 postoperative months in the outpatient&#xD;
      clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immediate postoperative pain</measure>
    <time_frame>up to first 15 postoperative days</time_frame>
    <description>All patients will complete a diary testing global postoperative pain every day, measured on a numerical scale from 0 to 10 during the first 15 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long-term control of hemorrhoidal symptoms</measure>
    <time_frame>1, 6, 12 and 24 months after surgery</time_frame>
    <description>Specific symptoms of hemorrhoidal disease (pain, itching , bleeding, soiling and hemorrhoidal prolapse reduction) will be evaluated. Te patient will mark in a questionaire the options &quot;yes&quot; or &quot;no&quot; for each item.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>SF-36 Quality of life score</measure>
    <time_frame>Preoperative, 6 and 12 months after surgery</time_frame>
    <description>All patients will be evaluated with a validated questionnaire of 36 questions on quality of life ( SF-36 )</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hemorrhoids</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Hemorrhoidectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open hemorrhoidectomy may include one to three anal cushions and made according to the Milligan-Morgan technique, with resection of the anal cushion and the external hemorrhoidal epidermal component using electrocautery and ligation of the hemorrhoidal base with absorbable suture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HAL-RAR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently, a running suture was added from the suture point to 5 mm above the dentate line to lift the prolapsing hemorrhoid. Other procedures will not be associated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hemorrhoidectomy</intervention_name>
    <description>Open hemorrhoidectomy may include one to three anal cushions and made according to the Milligan-Morgan technique, with resection of the anal cushion and the external hemorrhoidal epidermal component using electrocautery and ligation of the hemorrhoidal base with absorbable suture</description>
    <arm_group_label>Hemorrhoidectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HAL-RAR</intervention_name>
    <description>Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently, a running suture was added from the suture point to 5 mm above the dentate line to lift the prolapsing hemorrhoid. Other procedures will not be associated.</description>
    <arm_group_label>HAL-RAR</arm_group_label>
    <other_name>Hemorrhoid Artery Ligation and Rectoanal Repair</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching,&#xD;
             soiling or prolapse) that are eligible for surgical treatment with both methods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure,&#xD;
             perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal&#xD;
             stenosis.&#xD;
&#xD;
          -  Prior anorectal surgery .&#xD;
&#xD;
          -  Systemic pathology that could alter the outcome of the surgery as coagulopathies,&#xD;
             chronic pain with continued consumption of analgesics.&#xD;
&#xD;
          -  Age younger than 18 or older than 80 years, socio-pathology or inability to understand&#xD;
             the study objectives&#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>Fernando Carvajal, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Plató Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Plató</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.</citation>
    <PMID>2295392</PMID>
  </reference>
  <reference>
    <citation>Elmer SE, Nygren JO, Lenander CE. A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids. Dis Colon Rectum. 2013 Apr;56(4):484-90. doi: 10.1097/DCR.0b013e31827a8567.</citation>
    <PMID>23478616</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HAL-RAR</keyword>
  <keyword>Hemorrhoids</keyword>
  <keyword>Hemorrhoid artery ligation</keyword>
  <keyword>Anal repair</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Postoperative Complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
    <mesh_term>Pain, Postoperative</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/NCT02216305
org study id: HAL-RAR Plató 2.0
nct id: NCT02216305
lead sponsor: 
has dmc: No
HYPOTHESIS

        1. HAL- RAR causes a lower immediate postoperative pain compared with excision
           hemorrhoidectomy.

        2. HAL - RAR achieves similar immediate and long term results compared to the excision
           hemorrhoidectomy in the control of hemorrhoidal symptoms.

        3. The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.

      OBJECTIVES

        1. Compare postoperative pain of both techniques.

        2. Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique,
           and compare the results with those of the excision hemorrhoidectomy.

        3. Evaluate and compare the rate of complications of both techniques.

        4. Assess the quality of life of patients before and after treatment.
The classic surgical treatment of hemorrhoidal disease is the excisional hemorrhoidectomy,
      that consist in the surgical removal of one or more hemorrhoidal cushion, it is considered a
      safe, radical and definitive treatment; however, it is not exempt of complications and the
      postoperative pain is considerable. During the last two decades the concept of treatment has
      evolved to control hemorrhoidal symptoms with less invasive techniques, such as hemorrhoidal
      bands, arterial ligation Doppler guided hemorrhoidal and more recently, the association of
      anorectal repair or mucopexia for treating hemorrhoidal mucosal prolapse .

      MATERIAL AND METHODS

      The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació
      Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation).

      All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with
      both methods who agree to participate in the study, will be included in the prospective
      randomized trial. All patients will be required to sign the specific informed consent.

      Patients who are suitable for treatment with both techniques will be randomly assigned to the
      surgical technique.

      Inclusion criteria:

      1. Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or
      prolapse) that are eligible for surgical treatment with both methods.

      Exclusion criteria:

        1. Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure,
           perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal
           stenosis.

        2. Prior anorectal surgery .

        3. Systemic pathology that could alter the outcome of the surgery as coagulopathies,
           chronic pain with continued consumption of analgesics.

        4. Age younger than 18 or older than 80 years, socio-pathology or inability to understand
           the study objectives.

      All surgeries are performed on an outpatient basis under regional anesthesia and sedation for
      the same team of three surgeons. Preoperative preparation consists of a cleansing enema and
      no prophylactic antibiotics will be administered.

      Both techniques will be performed in "Jack -Knife" position. The open hemorrhoidectomy may
      include one to three anal cushions and made according to the Milligan-Morgan technique, with
      resection of the anal cushion and the external hemorrhoidal epidermal component using
      electrocautery and ligation of the hemorrhoidal base with absorbable suture. Once completed
      hemorrhoidectomy a perianal block is performed with bupivacaine/epinephrine.

      Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally
      invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the
      superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the
      blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently,
      a running suture was added from the suture point to 5 mm above the dentate line to lift the
      prolapsing hemorroid. Other procedures will not be associated, if necessary, the patient will
      be excluded from the study .

      The patient will be discharged if adequate pain control, oral tolerance and spontaneous
      diuresis is achieved, and after examination by the surgeon in order to discard immediate
      complications. The ambulatory treatment consists of an osmotic laxative (magnesium hydroxide
      ), oral analgesia with paracetamol/tramadol ( 325mg/37.5mg ) every 6 hours and Dexketoprofen
      (25 mg) every 8 hours, metamizol (575 mg) may be associated every 8 hours if pain. In case of
      persistent pain, the patient will be examined in emergency room.

      EVALUATION OF RESULTS A power analysis was performed to assess the study sample size.
      Choosing a power of 0.8 and a confidence interval of 95% α-error of 0.05, we calculated that
      20 patients were needed in each arm.

      All patients will be evaluated with a validated questionnaire of 36 questions on quality of
      life ( SF-36 ) and specific questions about specific symptoms of hemorrhoidal disease (pain,
      itching , bleeding, soiling and hemorrhoidal prolapse reduction ). The questionnaire will be
      answered before the intervention, after six and twelve months of follow up.

      All patients will complete a diary testing global postoperative pain every day, measured on a
      numerical scale from 0 to 10 during the first 15 days.

      The patients will be assessed on the day of discharge and at 7, 14, and 30 postoperative
      days. The patients will be evaluated at 6, 12 and 24 postoperative months in the outpatient
      clinic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Immediate postoperative pain
time frame: up to first 15 postoperative days
description: All patients will complete a diary testing global postoperative pain every day, measured on a numerical scale from 0 to 10 during the first 15 days.
measure: Long-term control of hemorrhoidal symptoms
time frame: 1, 6, 12 and 24 months after surgery
description: Specific symptoms of hemorrhoidal disease (pain, itching , bleeding, soiling and hemorrhoidal prolapse reduction) will be evaluated. Te patient will mark in a questionaire the options "yes" or "no" for each item.
measure: SF-36 Quality of life score
time frame: Preoperative, 6 and 12 months after surgery
description: All patients will be evaluated with a validated questionnaire of 36 questions on quality of life ( SF-36 )
arm group label: Hemorrhoidectomy
arm group type: Active Comparator
description: Open hemorrhoidectomy may include one to three anal cushions and made according to the Milligan-Morgan technique, with resection of the anal cushion and the external hemorrhoidal epidermal component using electrocautery and ligation of the hemorrhoidal base with absorbable suture
arm group label: HAL-RAR
arm group type: Active Comparator
description: Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently, a running suture was added from the suture point to 5 mm above the dentate line to lift the prolapsing hemorrhoid. Other procedures will not be associated.
intervention type: Procedure
intervention name: Hemorrhoidectomy
description: Open hemorrhoidectomy may include one to three anal cushions and made according to the Milligan-Morgan technique, with resection of the anal cushion and the external hemorrhoidal epidermal component using electrocautery and ligation of the hemorrhoidal base with absorbable suture
arm group label: Hemorrhoidectomy
intervention type: Procedure
intervention name: HAL-RAR
description: Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently, a running suture was added from the suture point to 5 mm above the dentate line to lift the prolapsing hemorrhoid. Other procedures will not be associated.
arm group label: HAL-RAR
other name: Hemorrhoid Artery Ligation and Rectoanal Repair
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Fernando Carvajal, Dr
role: Principal Investigator
affiliation: Hospital Plató Barcelona
facility: 
country: Spain
citation: Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.
PMID: 2295392
citation: Elmer SE, Nygren JO, Lenander CE. A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids. Dis Colon Rectum. 2013 Apr;56(4):484-90. doi: 10.1097/DCR.0b013e31827a8567.
PMID: 23478616
responsible party type: Sponsor
mesh term: Hemorrhoids
mesh term: Pain, Postoperative
sharing ipd: No