<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/NCT04504487</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS/LIVEDONORS/01</org_study_id>
    <nct_id>NCT04504487</nct_id>
  </id_info>
  <brief_title>Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy</brief_title>
  <official_title>&quot;Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study&quot;.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</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>
      It's a randomized control trial to compare early drain removal versus standard drain removal&#xD;
      after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate&#xD;
      the safety of early drain removal using 3x3 rule with routine drain removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Prophylactic abdominal drainage after donor right hepatectomy for LDLT has been a common&#xD;
           or even mandatory practice in most transplant centres.&#xD;
&#xD;
        -  This serves to monitor the occurrence of postoperative intraabdominal bleeding and is&#xD;
           used for the detection and drainage of any bile leakage.&#xD;
&#xD;
        -  Below table mentions both advantages and disadvantages of prophylactic drain placement&#xD;
           after hepatectomy.&#xD;
&#xD;
      Advantages&#xD;
&#xD;
        1. Early detection of haemorrhage&#xD;
&#xD;
        2. Early detection of bile leak&#xD;
&#xD;
        3. Early reintervention Disadvantages&#xD;
&#xD;
      1. Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3.&#xD;
      Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.&#xD;
&#xD;
        -  Our study in ILBS for ALF donors, the overall complication rate was 20% as per&#xD;
           Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2&#xD;
           complications. Major complications (3b and above) were seen in 4 (1.0%) patients.&#xD;
           Biliary complications were noted in 1.7% only.&#xD;
&#xD;
        -  In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows&#xD;
           for the early removal of the drain tube with minimum infection risk after liver&#xD;
           resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin&#xD;
           concentration is &lt;3 mg/dl on day 3 after operation.&#xD;
&#xD;
        -  In our institute we remove drain routinely, when output is less than 100ml and serous.&#xD;
           That is usually on postoperative day 5-7.&#xD;
&#xD;
        -  There is no randomized control trail done in donor hepatectomy comparing early versus&#xD;
           standard drain removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2021</start_date>
  <completion_date type="Actual">February 25, 2022</completion_date>
  <primary_completion_date type="Actual">February 25, 2022</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>safety of drain removal using 3x3 rule - overall complications.</measure>
    <time_frame>patient will be followed upto 3 months after surgery</time_frame>
    <description>Comprehensive complication index (CCI) - clavin dindo classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post operative pain relief</measure>
    <time_frame>patient will be followed upto 3 months after surgery</time_frame>
    <description>using Visual analogue score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bile leak</measure>
    <time_frame>patient will be followed upto 3 months after surgery</time_frame>
    <description>standard ISGLS definition - drain bilirubin measured in mg/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>patient will be followed upto 3 months after surgery</time_frame>
    <description>calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Site Infection (SSI)</measure>
    <time_frame>patient will be followed upto 3 months after surgery</time_frame>
    <description>patient has at least one of the following:&#xD;
purulent drainage from the superficial incision.&#xD;
organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)).&#xD;
superficial incision that is deliberately opened by a surgeon, physician* or physician designee and culture or non-culture based testing of the superficial incision or subcutaneous tissue is not performed AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat.&#xD;
diagnosis of a superficial incisional SSI by a physician* or physician designee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reintervention rate</measure>
    <time_frame>patient will be followed upto 3 months after surgery</time_frame>
    <description>defined as any additional abdominal intervention ( surgical or radiological) during the same hospital stay after the primary operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>readmission rate</measure>
    <time_frame>patient will be followed upto 3 months after surgery</time_frame>
    <description>90 day readmission rate - any hospital admission after the index admission.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Liver Transplant</condition>
  <arm_group>
    <arm_group_label>Early drain removal - POD3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Drain Removal</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drain removed routinely when the output is less than 100ml and serous in nature</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Drain Removal</intervention_name>
    <description>Abdominal drain placed during surgery removal</description>
    <arm_group_label>Early drain removal - POD3</arm_group_label>
    <arm_group_label>Routine Drain Removal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Donors evaluated as per institutional protocol for donor hepatectomy and found fit&#xD;
&#xD;
               -  Those who consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusing to consent for inclusion in the study.&#xD;
&#xD;
          -  Left lateral hepatectomy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ILBS - Parthiban</name>
      <address>
        <city>Delhi</city>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/27138885/</url>
    <description>Prospective Validation of Optimal Drain Management &quot;The 3 × 3 Rule&quot; after Liver Resection</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/30861306/</url>
    <description>Living Donor Liver Transplantation for Acute Liver Failure: Donor Safety and Recipient Outcome</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/23027077/</url>
    <description>Criteria for drain removal following liver resection</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04504487
org study id: ILBS/LIVEDONORS/01
nct id: NCT04504487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It's a randomized control trial to compare early drain removal versus standard drain removal
      after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate
      the safety of early drain removal using 3x3 rule with routine drain removal.
-  Prophylactic abdominal drainage after donor right hepatectomy for LDLT has been a common
           or even mandatory practice in most transplant centres.

        -  This serves to monitor the occurrence of postoperative intraabdominal bleeding and is
           used for the detection and drainage of any bile leakage.

        -  Below table mentions both advantages and disadvantages of prophylactic drain placement
           after hepatectomy.

      Advantages

        1. Early detection of haemorrhage

        2. Early detection of bile leak

        3. Early reintervention Disadvantages

      1. Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3.
      Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.

        -  Our study in ILBS for ALF donors, the overall complication rate was 20% as per
           Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2
           complications. Major complications (3b and above) were seen in 4 (1.0%) patients.
           Biliary complications were noted in 1.7% only.

        -  In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows
           for the early removal of the drain tube with minimum infection risk after liver
           resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin
           concentration is <3 mg/dl on day 3 after operation.

        -  In our institute we remove drain routinely, when output is less than 100ml and serous.
           That is usually on postoperative day 5-7.

        -  There is no randomized control trail done in donor hepatectomy comparing early versus
           standard drain removal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: safety of drain removal using 3x3 rule - overall complications.
time frame: patient will be followed upto 3 months after surgery
description: Comprehensive complication index (CCI) - clavin dindo classification
measure: Post operative pain relief
time frame: patient will be followed upto 3 months after surgery
description: using Visual analogue score
measure: Bile leak
time frame: patient will be followed upto 3 months after surgery
description: standard ISGLS definition - drain bilirubin measured in mg/dl.
measure: Length of hospital stay
time frame: patient will be followed upto 3 months after surgery
description: calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital
measure: Surgical Site Infection (SSI)
time frame: patient will be followed upto 3 months after surgery
description: patient has at least one of the following:
purulent drainage from the superficial incision.
organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)).
superficial incision that is deliberately opened by a surgeon, physician* or physician designee and culture or non-culture based testing of the superficial incision or subcutaneous tissue is not performed AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat.
diagnosis of a superficial incisional SSI by a physician* or physician designee.
measure: reintervention rate
time frame: patient will be followed upto 3 months after surgery
description: defined as any additional abdominal intervention ( surgical or radiological) during the same hospital stay after the primary operation
measure: readmission rate
time frame: patient will be followed upto 3 months after surgery
description: 90 day readmission rate - any hospital admission after the index admission.
arm group label: Early drain removal - POD3
arm group type: Experimental
description: Drain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature.
arm group label: Routine Drain Removal
arm group type: Placebo Comparator
description: Drain removed routinely when the output is less than 100ml and serous in nature
intervention type: Other
intervention name: Drain Removal
description: Abdominal drain placed during surgery removal
arm group label: Early drain removal - POD3
arm group label: Routine Drain Removal
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: India
url: https://pubmed.ncbi.nlm.nih.gov/27138885/
description: Prospective Validation of Optimal Drain Management "The 3 × 3 Rule" after Liver Resection
url: https://pubmed.ncbi.nlm.nih.gov/30861306/
description: Living Donor Liver Transplantation for Acute Liver Failure: Donor Safety and Recipient Outcome
url: https://pubmed.ncbi.nlm.nih.gov/23027077/
description: Criteria for drain removal following liver resection
responsible party type: Sponsor
sharing ipd: No