<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/NCT03768661</url>
  </required_header>
  <id_info>
    <org_study_id>SILS Chole Hernia</org_study_id>
    <nct_id>NCT03768661</nct_id>
  </id_info>
  <brief_title>Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy</brief_title>
  <official_title>Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Plató</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Plató</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>
      Single-incision laparoscopic cholecystectomy (SILC) requires a larger incision than standard&#xD;
      laparoscopy, which may increase the incidence of incisional hernias.&#xD;
&#xD;
      This study evaluated SILC and standard multiport cholecystectomy with respect to&#xD;
      perioperative outcomes, hospital stay, cosmetic results, and postoperative complications,&#xD;
      including the 5-years incisional hernia rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cohort study was performed for patients who underwent a laparoscopic cholecystectomy under&#xD;
      an institutional review approved protocol. Between 2009 and 2011, 45 unselected patients&#xD;
      underwent SILC performed by the same two surgeons.&#xD;
&#xD;
      The study inclusion criteria were the following: patients over 18 years with cholelithiasis,&#xD;
      and candidates for elective surgery with no significant cardiopulmonary, hepatic or renal&#xD;
      impairment (ASA score less than 4).&#xD;
&#xD;
      The exclusion criteria included the following: acute cholecystitis, associated CBD stones or&#xD;
      pancreatitis, an emergency operation for complicated disease, mental illness, or patient&#xD;
      refusal and/or absence of informed consent. All included patients signed a standard consent&#xD;
      form after being informed about the characteristics of the SILC procedure.&#xD;
&#xD;
      The outcomes of these patients were compared with those of a control cohort series of 140&#xD;
      patients who underwent standard LC (with the same inclusion and exclusion criteria) during&#xD;
      the same period.&#xD;
&#xD;
      The primary endpoint of the study was to determine the incisional hernia rate at the&#xD;
      umbilical wound after 5 years of follow-up. Hernias were defined as evidence of a hernia at&#xD;
      the clinical examination or those confirmed by ultrasound examination in case of clinical&#xD;
      doubt.&#xD;
&#xD;
      The study secondary endpoints included the following: duration of surgery (from the start of&#xD;
      the incision to skin closure), intraoperative and postoperative complications (30 days),&#xD;
      hospital stay, and cosmetic satisfaction results (measured using a visual analogue scale&#xD;
      score ranging from 0 to 10).&#xD;
&#xD;
      The following variables were also collected: age, gender, body mass index (BMI) and&#xD;
      comorbidities. The anesthetic risk was measured according to the ASA classification system.&#xD;
      Prolonged hospital stay (more than 24 h) and readmission (patients who returned for medical&#xD;
      consultation before scheduled follow-up) were also recorded. All data were collected&#xD;
      prospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2009</start_date>
  <completion_date type="Actual">November 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incisional hernia rate</measure>
    <time_frame>5 years</time_frame>
    <description>Incisional Hernia by clinical examination or CT scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operating time of the procedure</measure>
    <time_frame>During the perioperative period</time_frame>
    <description>Total duration of the surgical procedure (in minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative complications 1</measure>
    <time_frame>Rate of participants suffering from biliary complication assesed after 30 days of follow-up</time_frame>
    <description>biliary leak or bile duct injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative complications 2</measure>
    <time_frame>Rate of participants who needed reoperation assesed after 30 days of follow-up</time_frame>
    <description>reoperations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative complications 3</measure>
    <time_frame>Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up</time_frame>
    <description>surgical site occurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cosmetic satisfaction</measure>
    <time_frame>patient's own cosmetic evaluation using a visual analogue score ranging from 0 to 10 (0=worst to 10=best) after 30 days of follow-up</time_frame>
    <description>patient's cosmetic evaluation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">185</enrollment>
  <condition>Cholelithiasis</condition>
  <arm_group>
    <arm_group_label>SILC Group</arm_group_label>
    <description>patients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopy Group</arm_group_label>
    <description>patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-incision Laparoscopic cholecystectomy</intervention_name>
    <description>laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision</description>
    <arm_group_label>SILC Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Cholecystectomy</intervention_name>
    <description>laparoscopic cholecystectomy performed using three-trocars standard technique</description>
    <arm_group_label>Laparoscopy Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        - patients over 18 years with cholelithiasis and candidates for elective surgery&#xD;
        (cholecystectomy)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 18 years with cholelithiasis and candidates for elective surgery&#xD;
             (cholecystectomy)&#xD;
&#xD;
          -  abscence of significant cardiopulmonary, hepatic or renal impairment (ASA score less&#xD;
             than 4)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute cholecystitis&#xD;
&#xD;
          -  associated common bile duct stones or pancreatitis&#xD;
&#xD;
          -  emergency operation for complicated disease&#xD;
&#xD;
          -  ASA 4 (American Society of Anesthesiologists)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  mental illness&#xD;
&#xD;
          -  patient refusal and/or absence of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Hoyuela, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief, Dept. of Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Plató</name>
      <address>
        <city>Barcelona</city>
        <zip>08006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system</url>
    <description>American Society of Anesthesiologists. ASA Physical Status Classification System</description>
  </link>
  <link>
    <url>http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf</url>
    <description>Centers for Disease Control and Prevention. National Healthcare Safety Network (NHSN) Procedure-Associated (PA) Module: Surgical Site Infection (SSI) Event</description>
  </link>
  <link>
    <url>https://www.imim.cat/ofertadeserveis/software-public/granmo/</url>
    <description>Sample size and power calculator (version 7.12). Institut Municipal d'Investigació Mèdica, Barcelona, Spain.</description>
  </link>
  <reference>
    <citation>Antoniou SA, Pointner R, Granderath FA. Single-incision laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2011 Feb;25(2):367-77. doi: 10.1007/s00464-010-1217-5. Epub 2010 Jul 7.</citation>
    <PMID>20607556</PMID>
  </reference>
  <reference>
    <citation>Evers L, Bouvy N, Branje D, Peeters A. Single-incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Sep;31(9):3437-3448. doi: 10.1007/s00464-016-5381-0. Epub 2016 Dec 30.</citation>
    <PMID>28039641</PMID>
  </reference>
  <reference>
    <citation>Jorgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.</citation>
    <PMID>24536008</PMID>
  </reference>
  <reference>
    <citation>Arezzo A, Passera R, Bullano A, Mintz Y, Kedar A, Boni L, Cassinotti E, Rosati R, Fumagalli Romario U, Sorrentino M, Brizzolari M, Di Lorenzo N, Gaspari AL, Andreone D, De Stefani E, Navarra G, Lazzara S, Degiuli M, Shishin K, Khatkov I, Kazakov I, Schrittwieser R, Carus T, Corradi A, Sitzman G, Lacy A, Uranues S, Szold A, Morino M. Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial). Surg Endosc. 2017 Jul;31(7):2872-2880. doi: 10.1007/s00464-016-5298-7. Epub 2016 Oct 24.</citation>
    <PMID>27778171</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 13, 2020</last_update_submitted>
  <last_update_submitted_qc>April 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cholecystectomy</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>single-incision laparoscopic surgery</keyword>
  <keyword>incisional hernia</keyword>
  <keyword>trocar-site hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</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/NCT03768661
org study id: SILS Chole Hernia
nct id: NCT03768661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Single-incision laparoscopic cholecystectomy (SILC) requires a larger incision than standard
      laparoscopy, which may increase the incidence of incisional hernias.

      This study evaluated SILC and standard multiport cholecystectomy with respect to
      perioperative outcomes, hospital stay, cosmetic results, and postoperative complications,
      including the 5-years incisional hernia rate.
A cohort study was performed for patients who underwent a laparoscopic cholecystectomy under
      an institutional review approved protocol. Between 2009 and 2011, 45 unselected patients
      underwent SILC performed by the same two surgeons.

      The study inclusion criteria were the following: patients over 18 years with cholelithiasis,
      and candidates for elective surgery with no significant cardiopulmonary, hepatic or renal
      impairment (ASA score less than 4).

      The exclusion criteria included the following: acute cholecystitis, associated CBD stones or
      pancreatitis, an emergency operation for complicated disease, mental illness, or patient
      refusal and/or absence of informed consent. All included patients signed a standard consent
      form after being informed about the characteristics of the SILC procedure.

      The outcomes of these patients were compared with those of a control cohort series of 140
      patients who underwent standard LC (with the same inclusion and exclusion criteria) during
      the same period.

      The primary endpoint of the study was to determine the incisional hernia rate at the
      umbilical wound after 5 years of follow-up. Hernias were defined as evidence of a hernia at
      the clinical examination or those confirmed by ultrasound examination in case of clinical
      doubt.

      The study secondary endpoints included the following: duration of surgery (from the start of
      the incision to skin closure), intraoperative and postoperative complications (30 days),
      hospital stay, and cosmetic satisfaction results (measured using a visual analogue scale
      score ranging from 0 to 10).

      The following variables were also collected: age, gender, body mass index (BMI) and
      comorbidities. The anesthetic risk was measured according to the ASA classification system.
      Prolonged hospital stay (more than 24 h) and readmission (patients who returned for medical
      consultation before scheduled follow-up) were also recorded. All data were collected
      prospectively.
observational model: Cohort
time perspective: Retrospective
measure: incisional hernia rate
time frame: 5 years
description: Incisional Hernia by clinical examination or CT scan
measure: operating time of the procedure
time frame: During the perioperative period
description: Total duration of the surgical procedure (in minutes)
measure: postoperative complications 1
time frame: Rate of participants suffering from biliary complication assesed after 30 days of follow-up
description: biliary leak or bile duct injury
measure: postoperative complications 2
time frame: Rate of participants who needed reoperation assesed after 30 days of follow-up
description: reoperations
measure: postoperative complications 3
time frame: Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up
description: surgical site occurrence
measure: cosmetic satisfaction
time frame: patient's own cosmetic evaluation using a visual analogue score ranging from 0 to 10 (0=worst to 10=best) after 30 days of follow-up
description: patient's cosmetic evaluation
arm group label: SILC Group
description: patients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy
arm group label: Laparoscopy Group
description: patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy
intervention type: Procedure
intervention name: Single-incision Laparoscopic cholecystectomy
description: laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision
arm group label: SILC Group
intervention type: Procedure
intervention name: Laparoscopic Cholecystectomy
description: laparoscopic cholecystectomy performed using three-trocars standard technique
arm group label: Laparoscopy Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos Hoyuela, MD PhD
role: Principal Investigator
affiliation: Chief, Dept. of Surgery
facility: 
country: Spain
url: https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system
description: American Society of Anesthesiologists. ASA Physical Status Classification System
url: http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf
description: Centers for Disease Control and Prevention. National Healthcare Safety Network (NHSN) Procedure-Associated (PA) Module: Surgical Site Infection (SSI) Event
url: https://www.imim.cat/ofertadeserveis/software-public/granmo/
description: Sample size and power calculator (version 7.12). Institut Municipal d'Investigació Mèdica, Barcelona, Spain.
citation: Antoniou SA, Pointner R, Granderath FA. Single-incision laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2011 Feb;25(2):367-77. doi: 10.1007/s00464-010-1217-5. Epub 2010 Jul 7.
PMID: 20607556
citation: Evers L, Bouvy N, Branje D, Peeters A. Single-incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Sep;31(9):3437-3448. doi: 10.1007/s00464-016-5381-0. Epub 2016 Dec 30.
PMID: 28039641
citation: Jorgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.
PMID: 24536008
citation: Arezzo A, Passera R, Bullano A, Mintz Y, Kedar A, Boni L, Cassinotti E, Rosati R, Fumagalli Romario U, Sorrentino M, Brizzolari M, Di Lorenzo N, Gaspari AL, Andreone D, De Stefani E, Navarra G, Lazzara S, Degiuli M, Shishin K, Khatkov I, Kazakov I, Schrittwieser R, Carus T, Corradi A, Sitzman G, Lacy A, Uranues S, Szold A, Morino M. Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial). Surg Endosc. 2017 Jul;31(7):2872-2880. doi: 10.1007/s00464-016-5298-7. Epub 2016 Oct 24.
PMID: 27778171
responsible party type: Sponsor
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones
mesh term: Hernia
mesh term: Incisional Hernia
sharing ipd: No