<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/NCT03298997</url>
  </required_header>
  <id_info>
    <org_study_id>Hemorrhoids RCT</org_study_id>
    <nct_id>NCT03298997</nct_id>
  </id_info>
  <brief_title>Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using Ultrasound for Hemorrhoids</brief_title>
  <official_title>Comparison Between the Ligation and Hemorrhoidopexy Technique and the Conventional Ligation of Hemorrhoidal Arteries Using Ultrasound: a Prospective, Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Larissa University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Larissa University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to compare two techniques for treating hemorrhoids, the ligation&#xD;
      and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using&#xD;
      ultrasound, in patients with non-complicated hemorrhoids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical operations for the treatment of perianal diseases are a major part of all elective&#xD;
      surgical cases. The reduction in the hospitalization time of patients undergoing surgical&#xD;
      procedures for benign perianal diseases is to the benefit of both the patient and healthcare&#xD;
      provider. The importance of 'one day' surgical operations lies in the fact that the patient&#xD;
      returns directly to his social and working environment, while the number of occupied hospital&#xD;
      beds and the total hospitalization costs are reduced. A typical example is the goal set by&#xD;
      National Health Service (NHS), where the 75% of the scheduled operations should consist of&#xD;
      'one day' operations. In order to achieve this goal, several obstacles should be dealt with,&#xD;
      including the implementation of more efficient and safe surgical techniques. Therefore, this&#xD;
      would be associated with a decrease in the operation time, early recovery and faster hospital&#xD;
      discharge.&#xD;
&#xD;
      Hemorrhoids is one of the most common benign perianal diseases. According to a recent&#xD;
      prospective study of 976 patients, 38.93% of them suffered from hemorrhoids, with 8.16% and&#xD;
      0.53% being Grade III and IV, according to Goligher classification, respectively. The&#xD;
      percentage of the symptomatic patients was, also, significant (44.74%). Symptomatic&#xD;
      hemorrhoids, include bleeding, pruritus, pain, poor hygiene and the presence of palpable&#xD;
      hemorrhoid nodules.&#xD;
&#xD;
      As far as the blood supply of the rectum and the broader anatomic region is concerned, it is&#xD;
      provided by the superior, middle and inferior hemorrhoidal arteries. The superior&#xD;
      hemorrhoidal artery is a branch of the inferior mesenteric artery and is carried behind the&#xD;
      rectum, where it provides branches up to the internal sphincter muscle. The right and left&#xD;
      middle hemorrhoidal artery originate from the respective internal iliac artery and their&#xD;
      branches are cross-linked with the respective branches deriving from the superior&#xD;
      hemorrhoidal artery. Finally, inferior hemorrhoidal arteries derive from the respective&#xD;
      internal pudendal arteries. Correspondingly, hemorrhoidal venous plexus consists of the&#xD;
      middle and inferior hemorrhoidal veins, which through the internal iliac veins drain into the&#xD;
      inferior cava vein. Hemorrhoidal tissue constitutes a continence mechanism of the upper&#xD;
      rectum and consists of vascular tissue, connective tissue and smooth muscle fibers, within&#xD;
      the rectal canal. Through the approximation of the hemorrhoidal tissue, closure of the anal&#xD;
      canal and protection of the sphincter mechanism is achieved. Since modern pathogenesis&#xD;
      theories of hemorrhoidal disease attribute to the increased arterial flow in the hemorrhoidal&#xD;
      plexus the generating cause of this disease, recent anatomical studies mapped the vascular&#xD;
      network, indicating that the arteries are not confined to the anatomical regions described in&#xD;
      the literature.&#xD;
&#xD;
      According to recent guidelines, the modification of dietary intake, through the increase of&#xD;
      fluid and fiber intake, consists the first line treatment of symptomatic hemorrhoidal&#xD;
      disease. However, in Grade III-IV hemorrhoidal disease or in Grade II, where conservative&#xD;
      therapy failed, surgical intervention is required. Surgeon has plenty of techniques at his&#xD;
      disposal, in order to treat hemorrhoids. Examples of these techniques are operations, such as&#xD;
      hemorrhoidectomy (open, closed, Milligan-Morgan, Parks, using staplers, using energy sources,&#xD;
      e.g. Harmonic, Ligasure, Laser, bipolar forceps), elastic rings ligation, sclerotherapy and&#xD;
      Hemorrhoidal Arteries Ligation (ΗΑL) or Transanal Hemorrhoidal Dearterialization (THD).&#xD;
&#xD;
      Ligation of hemorrhoidal arteries using a Doppler apparatus, is a minimally invasive&#xD;
      technique that was first applied by Morinaga et al. in 1995 and has as principle the elective&#xD;
      ligation of the arteries that supply the hemorrhoidal plexus. In a recent meta-analysis, the&#xD;
      superiority of HAL in areas such as, postoperative bleeding, emergency reoperation, operative&#xD;
      duration, length of hospital stay and postoperative pain, was shown. A major drawback of this&#xD;
      technique, however, remains the high rate of recurrence, which ranges from 11.1% to 59.3%,&#xD;
      for Grade IV hemorrhoids.&#xD;
&#xD;
      Despite the comparative advantages of this minimally invasive technique, the high cost of the&#xD;
      necessary equipment and the respective consumables, is a barrier to its broad application.&#xD;
      Gupta et al. in a prospective randomized study, compared Doppler-Guided HAL (DG-HAL) to&#xD;
      hemorrhoid artery ligation and hemorrhoidopexy. Ligation was performed on the hemorrhoid&#xD;
      nodule at the 3rd, 7th and 11th hours, followed by continuous hemorrhoidal nodule ligation&#xD;
      and hemorrhoidopexy. The DG-HAL group had a significantly longer operative time (31 min vs 9&#xD;
      min) and post-operative pain (4.4 vs 2.2), without any differences in complication or&#xD;
      recurrence rates. Similarly, Huang et al., reported a respective ligation technique, where,&#xD;
      through the use of the index finger, the artery was palpated, followed by repeating&#xD;
      compression and ligation cycles, in order to fix the affected hemorrhoids above the dental&#xD;
      line. In this group, operative time was longer when compared to the DG-HAL group (35.57 vs.&#xD;
      12.73). There was no difference in terms of postoperative improvement of symptoms and&#xD;
      hospitalization duration. In the experimental group, however, the cost of hospitalization and&#xD;
      the relapse rate was significantly lower. Finally, Aigner et al., in a recent randomized&#xD;
      study, investigated the efficacy of hemorrhoidopexy for Grade III hemorrhoids. They concluded&#xD;
      that the techniques of hemorrhoidopexy are effective and the addition of DG-HAL does not&#xD;
      affect the results.&#xD;
&#xD;
      Given these facts, the present trial was designed, in order to compare the two techniques for&#xD;
      hemorrhoidal disease treatment, the ligation and hemorrhoidopexy technique and the&#xD;
      conventional ligation of hemorrhoid arteries using ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">April 15, 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Blinding will exist at the level of the patient and the investigator who will record the data postoperatively, regarding the surgical technique applied. There will be no blinding at the level of the surgeon and the anesthesiologist.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Symptoms Remission Rate</measure>
    <time_frame>1 month postoperatively</time_frame>
    <description>The primary endpoint of the present study, is the identification of difference in the symptoms remission rate, within one month postoperatively, between the ligation and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using ultrasound, in patients with non-complicated hemorrhoidal disease.&#xD;
If the symptoms are treated then it will be defined as=1 'YES' If the symptoms are not treated then it will be defined as=0 'NO'</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>Intraoperative period</time_frame>
    <description>The total operative time will be recorded. Measurement unit: minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative mobilization time</measure>
    <time_frame>Maximum time frame 24 hours postoperatively</time_frame>
    <description>The postoperative mobilization time of the patient will be recorded. Measurement unit: hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset of oral feeding</measure>
    <time_frame>Maximum time frame 24 hours postoperatively</time_frame>
    <description>The time that the patient started oral feeding will be recorded. Measurement unit: hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain level at 12 hours</measure>
    <time_frame>12 hours postoperatively</time_frame>
    <description>Postoperative pain level at 12 hours after surgery, quantified with the use of the Visual analogue scale (VAS) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypotension</measure>
    <time_frame>Maximum time frame 24 hours postoperatively</time_frame>
    <description>Occurrence of postoperative hypotension. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>Maximum time frame 24 hours postoperatively</time_frame>
    <description>Occurrence of postoperative nausea. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting</measure>
    <time_frame>Maximum time frame 24 hours postoperatively</time_frame>
    <description>Occurrence of postoperative vomiting. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache</measure>
    <time_frame>Maximum time frame 24 hours postoperatively</time_frame>
    <description>Occurrence of postoperative headache. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary retention</measure>
    <time_frame>Maximum time frame 24 hours postoperatively</time_frame>
    <description>Occurrence of postoperative urinary retention. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding at the operative site</measure>
    <time_frame>Maximum time frame 24 hours postoperatively</time_frame>
    <description>Occurrence of postoperative bleeding at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative discharge time</measure>
    <time_frame>Maximum time frame 48 hours postoperatively</time_frame>
    <description>Postoperative time that the patient can be safely discharged. Measurement unit: hours.&#xD;
The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfill the Clinical Discharge Criteria. More specifically, the patient should meet the following : steady vital signs, be oriented, without nausea or vomiting, mobilized with a steady gait, without a significant bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain level at 7 days</measure>
    <time_frame>7 days postoperatively</time_frame>
    <description>Postoperative pain level at 7 days after surgery, quantified with the use of the VAS scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oedema at the operative site</measure>
    <time_frame>7 days postoperatively</time_frame>
    <description>Occurrence of postoperative oedema at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma at the operative site</measure>
    <time_frame>7 days postoperatively</time_frame>
    <description>Occurrence of postoperative hematoma at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection at the operative site</measure>
    <time_frame>7 days postoperatively</time_frame>
    <description>Occurrence of postoperative infection at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stenosis at the operative site</measure>
    <time_frame>7 days postoperatively</time_frame>
    <description>Occurrence of postoperative stenosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative return to work time</measure>
    <time_frame>Postoperative period up to 1 month</time_frame>
    <description>The time that the patient resumed his work or normal activities will be recorded. Measurement unit: days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Occurrence of postoperative pruritus at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal proptosis</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Occurrence of postoperative mucosal proptosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perianal nodules</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Occurrence of postoperative perianal nodules. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constipation</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Occurrence of postoperative constipation. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tenesmus</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Occurrence of tenesmus. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reoperation</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Occurrence of reoperation. If the patient is reoperated, then it will be defined as=1 'YES' If the patient is not reoperated, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease recurrence rate</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Disease recurrence rate If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction level</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Satisfaction level measured at a 0-10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the quality of life of the patient</measure>
    <time_frame>Preoperatively, 1 month postoperatively and 1 year postoperatively</time_frame>
    <description>Difference in the quality of life of the patient, at 1 month and 1 year postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire, weighted for the Greek population.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hemorrhoids</condition>
  <arm_group>
    <arm_group_label>Ligation and Hemorrhoidopexy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will be placed in the Lloyd-Davies position. Provision of a sterile field, using a 10% povidone iodine solution. Rectal dilatation will be performed with a 10% xylocaine gel. Introduction of a proctoscope. Identification of the hemorrhoidal nodules (3rd, 7th, 11th hour). Confirmation of the hemorrhoidal artery location, through palpation. Ligation of the hemorrhoidal nodules using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).&#xD;
Placement of a fixative suture in the hemorrhoidal nodule and then performance of hemorrhoidopexy Placement of a hemostatic gauze in the surgical field. Prior to operation, the patients will be submitted to pudendal nerve block. Using an atraumatic 25 Gauge (G) needle, a 20ml lidocaine solution (diluted with saline in a 1:1 rate) will be administered bilaterally, medially to the ischial tuberosity.&#xD;
10 minutes before the operation, the patient will receive 1-2.5mg midazolam and 0.1-0.2 mg fentanyl.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound Guided Ligation of Hemorrhoidal Arteries</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient will be placed in the Lloyd-Davies position. Provision of a sterile field, using a 10% povidone iodine solution. Rectal dilatation will be performed with a 10% xylocaine gel. Use of a proctoscope combined with a Doppler sensor. After the hemorrhoidal artery localization, Z ligations will be placed, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).&#xD;
The proper artery ligation will be confirmed by the absence of the Doppler signal.&#xD;
In the presence of residual hemorrhoidal tissue hemorrhoidopexy will be performed, by applying a continuous suture.&#xD;
Placement of a hemostatic gauze in the surgical field. Prior to operation, the patients will be submitted to spinal anesthesia. Using an atraumatic 25 Gauge (G) needle, a levobupivacaine 5mg/ml and fentanyl 25mg solution, will be administered at the height of lumbar (L)2-L3 or L3-L4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ligation and Hemorrhoidopexy</intervention_name>
    <description>Identification through palpation and ligation of the hemorrhoidal nodules (3rd, 7th, 11th hour), using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).&#xD;
Prior to operation, the patients will be submitted to pudendal nerve block.</description>
    <arm_group_label>Ligation and Hemorrhoidopexy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound Guided Ligation of Hemorrhoidal Arteries</intervention_name>
    <description>Ultrasound guided identification and ligation of the hemorrhoidal arteries, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).&#xD;
Prior to operation, the patients will be submitted to spinal anesthesia.</description>
    <arm_group_label>Ultrasound Guided Ligation of Hemorrhoidal Arteries</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Μale or female&#xD;
&#xD;
          -  Age: 18 to 80 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score: I and II&#xD;
&#xD;
          -  Grade I, II, and III hemorrhoids&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute perianal diseases, such as perianal abscesses, complicated hemorrhoids (e.g.,&#xD;
             thrombosis) and acute anal fissure&#xD;
&#xD;
          -  Malignant perianal disorders&#xD;
&#xD;
          -  Patient age ≥ 80 years&#xD;
&#xD;
          -  ASA score ≥ ΙΙΙ&#xD;
&#xD;
          -  Presence of inflammatory bowel disease&#xD;
&#xD;
          -  History of a previous rectoanal operation&#xD;
&#xD;
          -  Presence of a clinically significant cardiovascular, respiratory, renal, hepatic or&#xD;
             metabolic disorder. Furthermore, diseases, such as obesity, psychiatric disorders or&#xD;
             gastrointestinal disorders constitute exclusion criteria&#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>Konstantinos Tepetes, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Department of Surgery, University Hospital of Larissa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery, University Hospital of Larissa</name>
      <address>
        <city>Lárisa</city>
        <state>Larissa</state>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
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    <citation>Spyridakis M, Christodoulidis G, Symeonidis D, Dimas D, Diamantis A, Polychronopoulou E, Tepetes K. Outcomes of Doppler-guided hemorrhoid artery ligation: analysis of 90 consecutive patients. Tech Coloproctol. 2011 Oct;15 Suppl 1:S21-4. doi: 10.1007/s10151-011-0727-z.</citation>
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  <results_reference>
    <citation>Perivoliotis K, Spyridakis M, Zintzaras E, Arnaoutoglou E, Pramateftakis MG, Tepetes K. An enhanced outpatient modality for the treatment of hemorrhoidal disease: preliminary results. G Chir. 2019 Mar-Apr;40(2):153-157.</citation>
    <PMID>31131818</PMID>
  </results_reference>
  <results_reference>
    <citation>Perivoliotis K, Spyridakis M, Zintzaras E, Arnaoutoglou E, Pramateftakis MG, Tepetes K. Non-Doppler hemorrhoidal artery ligation and hemorrhoidopexy combined with pudendal nerve block for the treatment of hemorrhoidal disease: a non-inferiority randomized controlled trial. Int J Colorectal Dis. 2021 Feb;36(2):353-363. doi: 10.1007/s00384-020-03768-8. Epub 2020 Oct 6.</citation>
    <PMID>33025104</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>October 8, 2020</last_update_submitted>
  <last_update_submitted_qc>October 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Larissa University Hospital</investigator_affiliation>
    <investigator_full_name>Perivoliotis Konstantinos</investigator_full_name>
    <investigator_title>Perivoliotis Konstantinos MD, MSc Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hemorrhoids</keyword>
  <keyword>Ligation</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Prospective</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <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>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03298997/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03298997/ICF_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03298997/SAP_004.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03298997
org study id: Hemorrhoids RCT
nct id: NCT03298997
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare two techniques for treating hemorrhoids, the ligation
      and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using
      ultrasound, in patients with non-complicated hemorrhoids.
Surgical operations for the treatment of perianal diseases are a major part of all elective
      surgical cases. The reduction in the hospitalization time of patients undergoing surgical
      procedures for benign perianal diseases is to the benefit of both the patient and healthcare
      provider. The importance of 'one day' surgical operations lies in the fact that the patient
      returns directly to his social and working environment, while the number of occupied hospital
      beds and the total hospitalization costs are reduced. A typical example is the goal set by
      National Health Service (NHS), where the 75% of the scheduled operations should consist of
      'one day' operations. In order to achieve this goal, several obstacles should be dealt with,
      including the implementation of more efficient and safe surgical techniques. Therefore, this
      would be associated with a decrease in the operation time, early recovery and faster hospital
      discharge.

      Hemorrhoids is one of the most common benign perianal diseases. According to a recent
      prospective study of 976 patients, 38.93% of them suffered from hemorrhoids, with 8.16% and
      0.53% being Grade III and IV, according to Goligher classification, respectively. The
      percentage of the symptomatic patients was, also, significant (44.74%). Symptomatic
      hemorrhoids, include bleeding, pruritus, pain, poor hygiene and the presence of palpable
      hemorrhoid nodules.

      As far as the blood supply of the rectum and the broader anatomic region is concerned, it is
      provided by the superior, middle and inferior hemorrhoidal arteries. The superior
      hemorrhoidal artery is a branch of the inferior mesenteric artery and is carried behind the
      rectum, where it provides branches up to the internal sphincter muscle. The right and left
      middle hemorrhoidal artery originate from the respective internal iliac artery and their
      branches are cross-linked with the respective branches deriving from the superior
      hemorrhoidal artery. Finally, inferior hemorrhoidal arteries derive from the respective
      internal pudendal arteries. Correspondingly, hemorrhoidal venous plexus consists of the
      middle and inferior hemorrhoidal veins, which through the internal iliac veins drain into the
      inferior cava vein. Hemorrhoidal tissue constitutes a continence mechanism of the upper
      rectum and consists of vascular tissue, connective tissue and smooth muscle fibers, within
      the rectal canal. Through the approximation of the hemorrhoidal tissue, closure of the anal
      canal and protection of the sphincter mechanism is achieved. Since modern pathogenesis
      theories of hemorrhoidal disease attribute to the increased arterial flow in the hemorrhoidal
      plexus the generating cause of this disease, recent anatomical studies mapped the vascular
      network, indicating that the arteries are not confined to the anatomical regions described in
      the literature.

      According to recent guidelines, the modification of dietary intake, through the increase of
      fluid and fiber intake, consists the first line treatment of symptomatic hemorrhoidal
      disease. However, in Grade III-IV hemorrhoidal disease or in Grade II, where conservative
      therapy failed, surgical intervention is required. Surgeon has plenty of techniques at his
      disposal, in order to treat hemorrhoids. Examples of these techniques are operations, such as
      hemorrhoidectomy (open, closed, Milligan-Morgan, Parks, using staplers, using energy sources,
      e.g. Harmonic, Ligasure, Laser, bipolar forceps), elastic rings ligation, sclerotherapy and
      Hemorrhoidal Arteries Ligation (ΗΑL) or Transanal Hemorrhoidal Dearterialization (THD).

      Ligation of hemorrhoidal arteries using a Doppler apparatus, is a minimally invasive
      technique that was first applied by Morinaga et al. in 1995 and has as principle the elective
      ligation of the arteries that supply the hemorrhoidal plexus. In a recent meta-analysis, the
      superiority of HAL in areas such as, postoperative bleeding, emergency reoperation, operative
      duration, length of hospital stay and postoperative pain, was shown. A major drawback of this
      technique, however, remains the high rate of recurrence, which ranges from 11.1% to 59.3%,
      for Grade IV hemorrhoids.

      Despite the comparative advantages of this minimally invasive technique, the high cost of the
      necessary equipment and the respective consumables, is a barrier to its broad application.
      Gupta et al. in a prospective randomized study, compared Doppler-Guided HAL (DG-HAL) to
      hemorrhoid artery ligation and hemorrhoidopexy. Ligation was performed on the hemorrhoid
      nodule at the 3rd, 7th and 11th hours, followed by continuous hemorrhoidal nodule ligation
      and hemorrhoidopexy. The DG-HAL group had a significantly longer operative time (31 min vs 9
      min) and post-operative pain (4.4 vs 2.2), without any differences in complication or
      recurrence rates. Similarly, Huang et al., reported a respective ligation technique, where,
      through the use of the index finger, the artery was palpated, followed by repeating
      compression and ligation cycles, in order to fix the affected hemorrhoids above the dental
      line. In this group, operative time was longer when compared to the DG-HAL group (35.57 vs.
      12.73). There was no difference in terms of postoperative improvement of symptoms and
      hospitalization duration. In the experimental group, however, the cost of hospitalization and
      the relapse rate was significantly lower. Finally, Aigner et al., in a recent randomized
      study, investigated the efficacy of hemorrhoidopexy for Grade III hemorrhoids. They concluded
      that the techniques of hemorrhoidopexy are effective and the addition of DG-HAL does not
      affect the results.

      Given these facts, the present trial was designed, in order to compare the two techniques for
      hemorrhoidal disease treatment, the ligation and hemorrhoidopexy technique and the
      conventional ligation of hemorrhoid arteries using ultrasound.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Blinding will exist at the level of the patient and the investigator who will record the data postoperatively, regarding the surgical technique applied. There will be no blinding at the level of the surgeon and the anesthesiologist.
measure: Symptoms Remission Rate
time frame: 1 month postoperatively
description: The primary endpoint of the present study, is the identification of difference in the symptoms remission rate, within one month postoperatively, between the ligation and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using ultrasound, in patients with non-complicated hemorrhoidal disease.
If the symptoms are treated then it will be defined as=1 'YES' If the symptoms are not treated then it will be defined as=0 'NO'
measure: Operative time
time frame: Intraoperative period
description: The total operative time will be recorded. Measurement unit: minutes
measure: Postoperative mobilization time
time frame: Maximum time frame 24 hours postoperatively
description: The postoperative mobilization time of the patient will be recorded. Measurement unit: hours
measure: Onset of oral feeding
time frame: Maximum time frame 24 hours postoperatively
description: The time that the patient started oral feeding will be recorded. Measurement unit: hours
measure: Postoperative pain level at 12 hours
time frame: 12 hours postoperatively
description: Postoperative pain level at 12 hours after surgery, quantified with the use of the Visual analogue scale (VAS) scale.
measure: Hypotension
time frame: Maximum time frame 24 hours postoperatively
description: Occurrence of postoperative hypotension. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Nausea
time frame: Maximum time frame 24 hours postoperatively
description: Occurrence of postoperative nausea. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Vomiting
time frame: Maximum time frame 24 hours postoperatively
description: Occurrence of postoperative vomiting. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Headache
time frame: Maximum time frame 24 hours postoperatively
description: Occurrence of postoperative headache. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Urinary retention
time frame: Maximum time frame 24 hours postoperatively
description: Occurrence of postoperative urinary retention. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Bleeding at the operative site
time frame: Maximum time frame 24 hours postoperatively
description: Occurrence of postoperative bleeding at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Postoperative discharge time
time frame: Maximum time frame 48 hours postoperatively
description: Postoperative time that the patient can be safely discharged. Measurement unit: hours.
The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfill the Clinical Discharge Criteria. More specifically, the patient should meet the following : steady vital signs, be oriented, without nausea or vomiting, mobilized with a steady gait, without a significant bleeding.
measure: Postoperative pain level at 7 days
time frame: 7 days postoperatively
description: Postoperative pain level at 7 days after surgery, quantified with the use of the VAS scale.
measure: Oedema at the operative site
time frame: 7 days postoperatively
description: Occurrence of postoperative oedema at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Hematoma at the operative site
time frame: 7 days postoperatively
description: Occurrence of postoperative hematoma at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Infection at the operative site
time frame: 7 days postoperatively
description: Occurrence of postoperative infection at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Stenosis at the operative site
time frame: 7 days postoperatively
description: Occurrence of postoperative stenosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Postoperative return to work time
time frame: Postoperative period up to 1 month
description: The time that the patient resumed his work or normal activities will be recorded. Measurement unit: days
measure: Pruritus
time frame: 1 year postoperatively
description: Occurrence of postoperative pruritus at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Mucosal proptosis
time frame: 1 year postoperatively
description: Occurrence of postoperative mucosal proptosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Perianal nodules
time frame: 1 year postoperatively
description: Occurrence of postoperative perianal nodules. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Constipation
time frame: 1 year postoperatively
description: Occurrence of postoperative constipation. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Tenesmus
time frame: 1 year postoperatively
description: Occurrence of tenesmus. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Reoperation
time frame: 1 year postoperatively
description: Occurrence of reoperation. If the patient is reoperated, then it will be defined as=1 'YES' If the patient is not reoperated, then it will be defined as=0 'NO'
measure: Disease recurrence rate
time frame: 1 year postoperatively
description: Disease recurrence rate If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Satisfaction level
time frame: 1 year postoperatively
description: Satisfaction level measured at a 0-10 scale
measure: Difference in the quality of life of the patient
time frame: Preoperatively, 1 month postoperatively and 1 year postoperatively
description: Difference in the quality of life of the patient, at 1 month and 1 year postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire, weighted for the Greek population.
arm group label: Ligation and Hemorrhoidopexy
arm group type: Experimental
description: The patient will be placed in the Lloyd-Davies position. Provision of a sterile field, using a 10% povidone iodine solution. Rectal dilatation will be performed with a 10% xylocaine gel. Introduction of a proctoscope. Identification of the hemorrhoidal nodules (3rd, 7th, 11th hour). Confirmation of the hemorrhoidal artery location, through palpation. Ligation of the hemorrhoidal nodules using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
Placement of a fixative suture in the hemorrhoidal nodule and then performance of hemorrhoidopexy Placement of a hemostatic gauze in the surgical field. Prior to operation, the patients will be submitted to pudendal nerve block. Using an atraumatic 25 Gauge (G) needle, a 20ml lidocaine solution (diluted with saline in a 1:1 rate) will be administered bilaterally, medially to the ischial tuberosity.
10 minutes before the operation, the patient will receive 1-2.5mg midazolam and 0.1-0.2 mg fentanyl.
arm group label: Ultrasound Guided Ligation of Hemorrhoidal Arteries
arm group type: Active Comparator
description: The patient will be placed in the Lloyd-Davies position. Provision of a sterile field, using a 10% povidone iodine solution. Rectal dilatation will be performed with a 10% xylocaine gel. Use of a proctoscope combined with a Doppler sensor. After the hemorrhoidal artery localization, Z ligations will be placed, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
The proper artery ligation will be confirmed by the absence of the Doppler signal.
In the presence of residual hemorrhoidal tissue hemorrhoidopexy will be performed, by applying a continuous suture.
Placement of a hemostatic gauze in the surgical field. Prior to operation, the patients will be submitted to spinal anesthesia. Using an atraumatic 25 Gauge (G) needle, a levobupivacaine 5mg/ml and fentanyl 25mg solution, will be administered at the height of lumbar (L)2-L3 or L3-L4.
intervention type: Procedure
intervention name: Ligation and Hemorrhoidopexy
description: Identification through palpation and ligation of the hemorrhoidal nodules (3rd, 7th, 11th hour), using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
Prior to operation, the patients will be submitted to pudendal nerve block.
arm group label: Ligation and Hemorrhoidopexy
intervention type: Procedure
intervention name: Ultrasound Guided Ligation of Hemorrhoidal Arteries
description: Ultrasound guided identification and ligation of the hemorrhoidal arteries, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
Prior to operation, the patients will be submitted to spinal anesthesia.
arm group label: Ultrasound Guided Ligation of Hemorrhoidal Arteries
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Konstantinos Tepetes, Professor
role: Study Director
affiliation: Department of Surgery, University Hospital of Larissa
facility: 
country: Greece
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responsible party type: Principal Investigator
investigator affiliation: Larissa University Hospital
investigator full name: Perivoliotis Konstantinos
investigator title: Perivoliotis Konstantinos MD, MSc Principal Investigator
mesh term: Hemorrhoids
sharing ipd: No
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