<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/NCT03026400</url>
  </required_header>
  <id_info>
    <org_study_id>2014-688</org_study_id>
    <nct_id>NCT03026400</nct_id>
  </id_info>
  <brief_title>Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Trial</brief_title>
  <official_title>Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université de Sherbrooke</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      While some studies have suggested that subumbilical and transumbilical incisions have a&#xD;
      similar clinical efficiency and safety, no study has yet evaluated their respective impact on&#xD;
      patient's postoperative aesthetic satisfaction.&#xD;
&#xD;
      The objective of this randomised trial is to compare patient's postoperative aesthetic&#xD;
      satisfaction depending on the type of incision which is performed during surgeries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in postoperative patient's aesthetic satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>An inverted 10 points Wong-Baker facial grimace-type scale was used to assess patient's satisfaction. Although the french version of our questionnaire was not validated, the concept behind Wong-Baker facial scale have been in various studies. In the case of this study, a 10 point score was associated with the highest possible satisfaction regarding the aesthetic appearance of the umbilicus.&#xD;
Patient's aesthetic satisfaction regarding the umbilicus was recorded preoperatively (right before the surgery), 1 month post-op and 6 months post-op. The change in postoperative patient's aesthetic satisfaction was assessed between pre-op vs 1 month post-op, pre-op vs 6 months post-op and 1 month vs 6 months post-op.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of patient's awareness regarding the aesthetic appearance of the umbilicus</measure>
    <time_frame>Pre-operative</time_frame>
    <description>YES/NO (no meaning that the patient gives little to no importance to the aesthetic appearance of the umbilicus).&#xD;
Patient's level of importance regarding the aesthetic appearance of the umbilicus was recorded preoperatively (right before the surgery).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Patient Satisfaction</condition>
  <condition>Surgical Wound</condition>
  <condition>Incision</condition>
  <condition>General Surgery</condition>
  <arm_group>
    <arm_group_label>Subumbilical incision</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The subumbilical incision was standardised. A curvilinear horizontal incision was performed to be able to reach the base of the umbilicus. The aponeurosis was incised with a scalpel and the peritoneal layer was open with a Kelly clamp. The incision was completed with the Hasson technique and a X-stitch was used for closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transumbilical incision</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The transumbilical incision was also standardised, inverting the umbilicus with graspers, then incising vertically the skin to reach the umbilical physiological hernia to enlarge it. The incision was also completed with the Hasson technique and a X-stitch was used for closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transumbilical incision</intervention_name>
    <description>While both types of incision were considered equal regarding the potential clinical outcome, the investigators considered the transumbilical incision to be the ''intervention'' and the subumbilical incision to be the ''standard care comparator'' since the transumbilical incision take a few more minutes to be completed.</description>
    <arm_group_label>Transumbilical incision</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subumbilical incision</intervention_name>
    <description>Considered here as the ''control'' intervention.</description>
    <arm_group_label>Subumbilical incision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18-70 years old having a planned laparoscopic surgery with an umbilical first&#xD;
             trocar at CHUS were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a BMI &gt; 40 or that had previous abdominal surgeries involving the&#xD;
             umbilicus were excluded.&#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_official>
    <last_name>Nathalie McFadden, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de recherche du Centre hospitalier universitaire de Sherbrooke</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>July 30, 2021</last_update_submitted>
  <last_update_submitted_qc>July 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <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/NCT03026400
org study id: 2014-688
nct id: NCT03026400
lead sponsor: 
has dmc: Yes
While some studies have suggested that subumbilical and transumbilical incisions have a
      similar clinical efficiency and safety, no study has yet evaluated their respective impact on
      patient's postoperative aesthetic satisfaction.

      The objective of this randomised trial is to compare patient's postoperative aesthetic
      satisfaction depending on the type of incision which is performed during surgeries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in postoperative patient's aesthetic satisfaction
time frame: 6 months
description: An inverted 10 points Wong-Baker facial grimace-type scale was used to assess patient's satisfaction. Although the french version of our questionnaire was not validated, the concept behind Wong-Baker facial scale have been in various studies. In the case of this study, a 10 point score was associated with the highest possible satisfaction regarding the aesthetic appearance of the umbilicus.
Patient's aesthetic satisfaction regarding the umbilicus was recorded preoperatively (right before the surgery), 1 month post-op and 6 months post-op. The change in postoperative patient's aesthetic satisfaction was assessed between pre-op vs 1 month post-op, pre-op vs 6 months post-op and 1 month vs 6 months post-op.
measure: Level of patient's awareness regarding the aesthetic appearance of the umbilicus
time frame: Pre-operative
description: YES/NO (no meaning that the patient gives little to no importance to the aesthetic appearance of the umbilicus).
Patient's level of importance regarding the aesthetic appearance of the umbilicus was recorded preoperatively (right before the surgery).
arm group label: Subumbilical incision
arm group type: Other
description: The subumbilical incision was standardised. A curvilinear horizontal incision was performed to be able to reach the base of the umbilicus. The aponeurosis was incised with a scalpel and the peritoneal layer was open with a Kelly clamp. The incision was completed with the Hasson technique and a X-stitch was used for closure.
arm group label: Transumbilical incision
arm group type: Other
description: The transumbilical incision was also standardised, inverting the umbilicus with graspers, then incising vertically the skin to reach the umbilical physiological hernia to enlarge it. The incision was also completed with the Hasson technique and a X-stitch was used for closure.
intervention type: Procedure
intervention name: Transumbilical incision
description: While both types of incision were considered equal regarding the potential clinical outcome, the investigators considered the transumbilical incision to be the ''intervention'' and the subumbilical incision to be the ''standard care comparator'' since the transumbilical incision take a few more minutes to be completed.
arm group label: Transumbilical incision
intervention type: Procedure
intervention name: Subumbilical incision
description: Considered here as the ''control'' intervention.
arm group label: Subumbilical incision
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nathalie McFadden, M.D
role: Principal Investigator
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Surgical Wound
sharing ipd: No