<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/NCT04459039</url>
  </required_header>
  <id_info>
    <org_study_id>2-106-05-063</org_study_id>
    <nct_id>NCT04459039</nct_id>
  </id_info>
  <brief_title>Fluid Restriction After Stapled Hemorrhoidopexy</brief_title>
  <official_title>Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tri-Service General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid&#xD;
      restriction is commonly recommended to minimize complications. However, the need for&#xD;
      postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is&#xD;
      unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy&#xD;
      with/without partial external hemorrhoidectomy could reduce urinary retention and&#xD;
      postoperative pain.&#xD;
&#xD;
      PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we&#xD;
      enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy&#xD;
      with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was&#xD;
      administered to the fluid restriction group after the operation, and 1000 mL/12 h was given&#xD;
      to the non-fluid-restriction group. We focused on the need for fluid restriction after&#xD;
      stapled hemorrhoidopexy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>first urination</measure>
    <time_frame>1 day</time_frame>
    <description>the time to first urination after surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Fluid Restriction</condition>
  <arm_group>
    <arm_group_label>Fluid restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-fluid restriction</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1000 mL 0.9% sterile saline</intervention_name>
    <description>Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.</description>
    <arm_group_label>Fluid restriction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>250 mL 0.9% sterile saline</intervention_name>
    <description>Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.</description>
    <arm_group_label>Non-fluid restriction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gr. III-IV hemorrhoids paitents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt;20 or &gt;80&#xD;
&#xD;
          -  Allergy to NSAID or opoids&#xD;
&#xD;
          -  Impaired renal function&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tri-Service General Hospital, National Defense Medical Center</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
    <investigator_full_name>Yi-Chiao Cheng</investigator_full_name>
    <investigator_title>Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center</investigator_title>
  </responsible_party>
  <keyword>Stapled hemorrhoidopexy</keyword>
  <keyword>Fluid restriction</keyword>
  <keyword>Urinary retention</keyword>
  <!-- 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/NCT04459039
org study id: 2-106-05-063
nct id: NCT04459039
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid
      restriction is commonly recommended to minimize complications. However, the need for
      postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is
      unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy
      with/without partial external hemorrhoidectomy could reduce urinary retention and
      postoperative pain.

      PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we
      enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy
      with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was
      administered to the fluid restriction group after the operation, and 1000 mL/12 h was given
      to the non-fluid-restriction group. We focused on the need for fluid restriction after
      stapled hemorrhoidopexy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: first urination
time frame: 1 day
description: the time to first urination after surgery
arm group label: Fluid restriction
arm group type: Experimental
description: Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
arm group label: Non-fluid restriction
arm group type: Placebo Comparator
description: Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously
intervention type: Drug
intervention name: 1000 mL 0.9% sterile saline
description: Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
arm group label: Fluid restriction
intervention type: Drug
intervention name: 250 mL 0.9% sterile saline
description: Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.
arm group label: Non-fluid restriction
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yi-Chiao Cheng
investigator title: Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center