<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/NCT03265990</url>
  </required_header>
  <id_info>
    <org_study_id>ligaHaemorrhoidectomy</org_study_id>
    <nct_id>NCT03265990</nct_id>
  </id_info>
  <brief_title>Haemorrhoidectomy by Ligasure and Conventional Surgery</brief_title>
  <official_title>Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Comparison between Haemorrhoidectomy by Ligasure and conventional surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemorrhoids, a varicose condition are one of the commonest illnesses which causes per rectal&#xD;
      bleeding . Hemorrhoidectomy is the standard operation for grades III and IV hemorrhoids; it&#xD;
      is superior to any proposed conservative procedure. Conventional haemorrhoidectomy is the&#xD;
      open surgical procedure in which the haemorrhoid pedicle is ligated by a transfixing suture&#xD;
      which may lead to some postoperative complications mostly pain, bleeding and wound infection&#xD;
      which ultimately cause prolonged stay in hospital.&#xD;
&#xD;
      A number of surgeons believe that by avoiding vascular pedicle ligation the chances of&#xD;
      secondary bleeding can be decreased .This stimulated the researchers to develop new&#xD;
      techniques with a less severe course and faster recovery . Recent advances in instrumental&#xD;
      technology including the bipolar electrothermal device, ultrasonic scalpel, and circular&#xD;
      stapler are gaining popularity as effective alternatives in hemorrhoidectomy . Of these&#xD;
      instruments, the LigaSure vessel sealing system has been recently introduced as a tool&#xD;
      conceived to upgrade the conventional treatment of haemorrhoids. This reduces anal spasm and&#xD;
      allows performing a bloodless haemorrhoidectomy with reduced post- operative pain and fast&#xD;
      healing . .Thus this operation can be recommended as the ideal technique. Many trials were&#xD;
      performed to compare LigaSure hemorrhoidectomy with conventional hemorrhoidectomy, although&#xD;
      an overall favorable trend exists toward LigaSure, conclusions are not univocal and&#xD;
      definitive; this creates some uncertainty, also considering the increasing cost for this&#xD;
      disposable device: thus it is essential to keep on experimenting to determine whenever an&#xD;
      actual advantage exists.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2018</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>Post operative pain</measure>
    <time_frame>1 month</time_frame>
    <description>pain will be evaluated with visual analogue scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra operative blood loss</measure>
    <time_frame>1 day</time_frame>
    <description>Amount of blood loss by cc during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>2 months</time_frame>
    <description>the healing of mucosa and skin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ligature; Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional haemrrhoidectomy,Ferguson technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ligasure haemorrhoidectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ligasure haemroidectomy</intervention_name>
    <description>In ligasure group,After the haemorrhoids are prolapsed out from the anal canal with an artery forceps,Ligasure haemorrhoidectomy will be performed by applying the ligasure forceps close to the edge of each pile.Repeated applications of the device will be performed and excision will be continued into the anal canal,lifting the pile from the internal anal sphincter,to the level of the vascular pedicle,which will be finally divided.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional haemorrhoidectomy</intervention_name>
    <description>According to the Ferguson technique&#xD;
Manual anal sphincter stretching up to 4 fingers&#xD;
Delivery of hemorrhoidal masses with artery forceps,one being applied at the base of haemorrhoid,the other at the apex.&#xD;
skin incision at the base of haemorrhoids and submucosal dissection to lift the haemorrhoid mass off the internal sphincter.&#xD;
After this the haemorrhoid pedicle will be transfixed and the mucosal edges of the defect will be opposed.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients with ages between 18 to 70 years with symptomatic grade III, or IV&#xD;
             hemorrhoid who will be operated on at the Department of general Surgery, Assuit&#xD;
             University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age older than 70 years&#xD;
&#xD;
          -  patients with Grade I and II haemorrhoids&#xD;
&#xD;
          -  patients on anticoagulants&#xD;
&#xD;
          -  patients with liver cirrhosis&#xD;
&#xD;
          -  patients with the hematological disorder&#xD;
&#xD;
          -  patients with the concomitant anal disease&#xD;
&#xD;
          -  patients had previous history of anorectal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Abdel Rhman Refaie Kamel</last_name>
    <phone>01097722233</phone>
    <email>Refaay120@gmail.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Abdulrahman Refaay Ahmed</investigator_full_name>
    <investigator_title>araahmed</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- 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/NCT03265990
org study id: ligaHaemorrhoidectomy
nct id: NCT03265990
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison between Haemorrhoidectomy by Ligasure and conventional surgery
Hemorrhoids, a varicose condition are one of the commonest illnesses which causes per rectal
      bleeding . Hemorrhoidectomy is the standard operation for grades III and IV hemorrhoids; it
      is superior to any proposed conservative procedure. Conventional haemorrhoidectomy is the
      open surgical procedure in which the haemorrhoid pedicle is ligated by a transfixing suture
      which may lead to some postoperative complications mostly pain, bleeding and wound infection
      which ultimately cause prolonged stay in hospital.

      A number of surgeons believe that by avoiding vascular pedicle ligation the chances of
      secondary bleeding can be decreased .This stimulated the researchers to develop new
      techniques with a less severe course and faster recovery . Recent advances in instrumental
      technology including the bipolar electrothermal device, ultrasonic scalpel, and circular
      stapler are gaining popularity as effective alternatives in hemorrhoidectomy . Of these
      instruments, the LigaSure vessel sealing system has been recently introduced as a tool
      conceived to upgrade the conventional treatment of haemorrhoids. This reduces anal spasm and
      allows performing a bloodless haemorrhoidectomy with reduced post- operative pain and fast
      healing . .Thus this operation can be recommended as the ideal technique. Many trials were
      performed to compare LigaSure hemorrhoidectomy with conventional hemorrhoidectomy, although
      an overall favorable trend exists toward LigaSure, conclusions are not univocal and
      definitive; this creates some uncertainty, also considering the increasing cost for this
      disposable device: thus it is essential to keep on experimenting to determine whenever an
      actual advantage exists.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post operative pain
time frame: 1 month
description: pain will be evaluated with visual analogue scale
measure: Intra operative blood loss
time frame: 1 day
description: Amount of blood loss by cc during surgery
measure: Wound healing
time frame: 2 months
description: the healing of mucosa and skin
arm group label: Group A
arm group type: Experimental
description: Conventional haemrrhoidectomy,Ferguson technique
arm group label: Group B
arm group type: Experimental
description: Ligasure haemorrhoidectomy
intervention type: Procedure
intervention name: ligasure haemroidectomy
description: In ligasure group,After the haemorrhoids are prolapsed out from the anal canal with an artery forceps,Ligasure haemorrhoidectomy will be performed by applying the ligasure forceps close to the edge of each pile.Repeated applications of the device will be performed and excision will be continued into the anal canal,lifting the pile from the internal anal sphincter,to the level of the vascular pedicle,which will be finally divided.
arm group label: Group B
intervention type: Procedure
intervention name: Conventional haemorrhoidectomy
description: According to the Ferguson technique
Manual anal sphincter stretching up to 4 fingers
Delivery of hemorrhoidal masses with artery forceps,one being applied at the base of haemorrhoid,the other at the apex.
skin incision at the base of haemorrhoids and submucosal dissection to lift the haemorrhoid mass off the internal sphincter.
After this the haemorrhoid pedicle will be transfixed and the mucosal edges of the defect will be opposed.
arm group label: Group A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Abdel Rhman Refaie Kamel
phone: 01097722233
email: Refaay120@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Abdulrahman Refaay Ahmed
investigator title: araahmed
mesh term: Hemorrhage