<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/NCT01729741</url>
  </required_header>
  <id_info>
    <org_study_id>Rec Ref 2010-139</org_study_id>
    <nct_id>NCT01729741</nct_id>
  </id_info>
  <brief_title>Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital</brief_title>
  <official_title>Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Makerere University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thyroidectomy is one of the most commonly performed operations in general surgery. Available&#xD;
      data seem to suggest an association between no-drain usage and a shorter duration of hospital&#xD;
      stay. Seung et al found that the (following thyroidectomy) time to discharge after&#xD;
      thyroidectomy was significantly shorter in the no drain group compared to the drain group.&#xD;
      Similar results were recorded in a study conducted by Davari et al. Hyoung et al reported the&#xD;
      incidence of hematoma formation post- thyroidectomy to be varying between 0.3%-4.3%. Tahsin&#xD;
      et al reported that post-thyroidectomy bleeding is as rare as 0.3%-1.0%. The fear of an&#xD;
      hematoma enlarging and obstructing the airway and causing difficulty in breathing, prompts&#xD;
      many surgeons to use drains routinely after any type of thyroid surgery. The main reason is&#xD;
      to drain off a possible postoperative hemorrhage, which may compress the airway and produce&#xD;
      respiratory fail&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be aimed at comparing the patient outcomes with drain and no-drain insertion&#xD;
      methods after thyroidectomy in a resource limited setting.&#xD;
&#xD;
      Study population: All adult patients aged between 18 to 79 years who attended the&#xD;
      endocrinology outpatient clinic and had been diagnosed with goiter.&#xD;
&#xD;
      Study Participants: All adult patients with goiters who were eligible for thyroidectomy&#xD;
      Inclusion criteria: All adult patients aged between 18 to 79 years with a diagnosis of goiter&#xD;
      who consented to participate in the study.&#xD;
&#xD;
      Exclusion criteria: The investigators excluded patients with goiter who had a history&#xD;
      suggestive of bleeding tendencies, recurrent goiter, and thyroid cancer with fixation of the&#xD;
      thyroid gland to surrounding structures and had uncontrolled co-morbidities such as diabetes&#xD;
      mellitus (DM) and hypertension (HT).&#xD;
&#xD;
      Inserting a drain after goiter surgery and not inserting a drain is the intervention all&#xD;
      participants receive the same treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">April 2011</completion_date>
  <primary_completion_date type="Actual">April 2011</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>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>7 days</time_frame>
    <description>Duration of hospital stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Haematoma formation</measure>
    <time_frame>7 days</time_frame>
    <description>post operative complication</description>
  </secondary_outcome>
  <other_outcome>
    <measure>wound sepsis</measure>
    <time_frame>7 days</time_frame>
    <description>post operative wound infection</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Hospital Admission Duration</condition>
  <condition>Postoperative Hematoma Formation</condition>
  <condition>Wound Sepsis</condition>
  <arm_group>
    <arm_group_label>No drain</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No drain was inserted after Thyroid surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A drain was inserted after thyroid surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>drain was inserted after thyroid surgery</intervention_name>
    <description>insertion of drain after thyroid surgery</description>
    <arm_group_label>Drain</arm_group_label>
    <other_name>drains</other_name>
    <other_name>thyroid surgery</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients aged between 18 to 79 years with a diagnosis of goiter who&#xD;
             consented to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We excluded patients with goiter who had a history suggestive of bleeding tendencies,&#xD;
             recurrent goiter, and thyroid cancer with fixation of the thyroid gland to surrounding&#xD;
             structures and had uncontrolled co-morbidities such as diabetes mellitus (DM) and&#xD;
             hypertension (HT).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane O Fualal, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mulago Hospital, Uganda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Makerere University</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mulago Hospital</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <reference>
    <citation>Khanna J, Mohil RS, Chintamani, Bhatnagar D, Mittal MK, Sahoo M, Mehrotra M. Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study [ISRCTN63623153]. BMC Surg. 2005 May 19;5:11. doi: 10.1186/1471-2482-5-11.</citation>
    <PMID>15946379</PMID>
  </reference>
  <verification_date>December 2010</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 19, 2012</last_update_submitted>
  <last_update_submitted_qc>November 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drain or no drain</keyword>
  <keyword>Thyroid surgery</keyword>
  <keyword>Randomized Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma</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/NCT01729741
org study id: Rec Ref 2010-139
nct id: NCT01729741
lead sponsor: 
collaborator: 
has dmc: Yes
Thyroidectomy is one of the most commonly performed operations in general surgery. Available
      data seem to suggest an association between no-drain usage and a shorter duration of hospital
      stay. Seung et al found that the (following thyroidectomy) time to discharge after
      thyroidectomy was significantly shorter in the no drain group compared to the drain group.
      Similar results were recorded in a study conducted by Davari et al. Hyoung et al reported the
      incidence of hematoma formation post- thyroidectomy to be varying between 0.3%-4.3%. Tahsin
      et al reported that post-thyroidectomy bleeding is as rare as 0.3%-1.0%. The fear of an
      hematoma enlarging and obstructing the airway and causing difficulty in breathing, prompts
      many surgeons to use drains routinely after any type of thyroid surgery. The main reason is
      to drain off a possible postoperative hemorrhage, which may compress the airway and produce
      respiratory fail
This study will be aimed at comparing the patient outcomes with drain and no-drain insertion
      methods after thyroidectomy in a resource limited setting.

      Study population: All adult patients aged between 18 to 79 years who attended the
      endocrinology outpatient clinic and had been diagnosed with goiter.

      Study Participants: All adult patients with goiters who were eligible for thyroidectomy
      Inclusion criteria: All adult patients aged between 18 to 79 years with a diagnosis of goiter
      who consented to participate in the study.

      Exclusion criteria: The investigators excluded patients with goiter who had a history
      suggestive of bleeding tendencies, recurrent goiter, and thyroid cancer with fixation of the
      thyroid gland to surrounding structures and had uncontrolled co-morbidities such as diabetes
      mellitus (DM) and hypertension (HT).

      Inserting a drain after goiter surgery and not inserting a drain is the intervention all
      participants receive the same treatment
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Duration of hospital stay
time frame: 7 days
description: Duration of hospital stay
measure: Haematoma formation
time frame: 7 days
description: post operative complication
measure: wound sepsis
time frame: 7 days
description: post operative wound infection
arm group label: No drain
arm group type: No Intervention
description: No drain was inserted after Thyroid surgery
arm group label: Drain
arm group type: Experimental
description: A drain was inserted after thyroid surgery
intervention type: Procedure
intervention name: drain was inserted after thyroid surgery
description: insertion of drain after thyroid surgery
arm group label: Drain
other name: drains
other name: thyroid surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Jane O Fualal, MD
role: Study Chair
affiliation: Mulago Hospital, Uganda
facility: 
facility: 
country: Uganda
citation: Khanna J, Mohil RS, Chintamani, Bhatnagar D, Mittal MK, Sahoo M, Mehrotra M. Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study [ISRCTN63623153]. BMC Surg. 2005 May 19;5:11. doi: 10.1186/1471-2482-5-11.
PMID: 15946379
responsible party type: Sponsor
mesh term: Hematoma