<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/NCT04405713</url>
  </required_header>
  <id_info>
    <org_study_id>early LC for ACC</org_study_id>
    <nct_id>NCT04405713</nct_id>
  </id_info>
  <brief_title>Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis</brief_title>
  <acronym>ACC</acronym>
  <official_title>Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      The ideal timing for ELC continues to be debatable in patients with acute calculator&#xD;
      cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in&#xD;
      ACC on surgical outcomes in terms of safety and efficacy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicentric analysis involved of successive patients with ACC ELC between April 2018&#xD;
      and March 2020. Patients were divided into three groups according to the timing of the&#xD;
      surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days&#xD;
      (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of&#xD;
      postoperative complications The secondary outcomes were conversion rate, blood loss,&#xD;
      operative times, operational difficulty, the cost-benefit relationship, postoperative stay&#xD;
      with each treatment line.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">March 25, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients with ACC were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the incidence of postoperative morbidity</measure>
    <time_frame>30 DAYS</time_frame>
    <description>the incidence of postoperative morbidity during the 30th day of postoperative procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>conversion rate</measure>
    <time_frame>INTRAOPERATIVE</time_frame>
    <description>conversion rate to open cholecystectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood loss</measure>
    <time_frame>intraoperative</time_frame>
    <description>blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>overall hospital stay</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">900</enrollment>
  <condition>Acute Cholecystitis</condition>
  <arm_group>
    <arm_group_label>from the onset of symptoms within the first 3 days (group 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ELC for ACC from the onset of symptoms within the first 3 days (group 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>from the onset of symptoms within the 4-7 days</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ELC for ACC from the onset of symptoms within the4-7 days (group II)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>from the onset of symptoms beyond 7 days</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ELC for ACC from the onset of symptoms beyond 7 days (group III)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>from the onset of symptoms within the first 3 days</intervention_name>
    <description>ELC within 3 days of onset of ACC</description>
    <arm_group_label>from the onset of symptoms within the first 3 days (group 1)</arm_group_label>
    <other_name>group 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>: from the onset of symptoms within the 4-7 days</intervention_name>
    <description>ELC 4-7days of onset of ACC</description>
    <arm_group_label>from the onset of symptoms within the 4-7 days</arm_group_label>
    <other_name>Group II</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>from the onset of symptoms beyond 7 days</intervention_name>
    <description>ELC after 7days of onset of ACC</description>
    <arm_group_label>from the onset of symptoms beyond 7 days</arm_group_label>
    <other_name>Group III</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ACC patients who underwent early LC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score&#xD;
        4, Patients scheduled for DLC with failed medical treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayman E Nakeeb</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University, Gastrointestinal Surgery Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mohamed Attea</name>
      <address>
        <city>Mansoura</city>
        <zip>356111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.mans.edu.eg/en/</url>
    <description>Mansoura university</description>
  </link>
  <results_reference>
    <citation>El Zanati H, Nassar AHM, Zino S, Katbeh T, Ng HJ, Abdellatif A. Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes. JSLS. 2020 Apr-Jun;24(2):e2020.00015. doi: 10.4293/JSLS.2020.00015.</citation>
    <PMID>32425482</PMID>
  </results_reference>
  <results_reference>
    <citation>Mora-Guzman I, Di Martino M, Gancedo Quintana A, Martin-Perez E. Laparoscopic Cholecystectomy for Acute Cholecystitis: Is the Surgery Still Safe beyond the 7-Day Barrier? J Gastrointest Surg. 2020 Aug;24(8):1827-1832. doi: 10.1007/s11605-019-04335-5. Epub 2019 Aug 6. Erratum In: J Gastrointest Surg. 2021 Jan;25(1):337.</citation>
    <PMID>31388885</PMID>
  </results_reference>
  <results_reference>
    <citation>Brunee L, Hauters P, Closset J, Fromont G, Puia-Negelescu S; Club Coelio. Assessment of the optimal timing for early laparoscopic cholecystectomy in acute cholecystitis: a prospective study of the Club Coelio. Acta Chir Belg. 2019 Oct;119(5):309-315. doi: 10.1080/00015458.2018.1529344. Epub 2018 Oct 25.</citation>
    <PMID>30354853</PMID>
  </results_reference>
  <results_reference>
    <citation>Inoue K, Ueno T, Nishina O, Douchi D, Shima K, Goto S, Takahashi M, Shibata C, Naito H. Optimal timing of cholecystectomy after percutaneous gallbladder drainage for severe cholecystitis. BMC Gastroenterol. 2017 May 31;17(1):71. doi: 10.1186/s12876-017-0631-8.</citation>
    <PMID>28569137</PMID>
  </results_reference>
  <results_reference>
    <citation>Onoe S, Kaneoka Y, Maeda A, Takayama Y, Fukami Y. Feasibility of laparoscopic cholecystectomy for acute cholecystitis beyond 72 h of symptom onset. Updates Surg. 2016 Dec;68(4):377-383. doi: 10.1007/s13304-016-0409-5. Epub 2016 Oct 26.</citation>
    <PMID>27785732</PMID>
  </results_reference>
  <results_reference>
    <citation>Menahem B, Mulliri A, Fohlen A, Guittet L, Alves A, Lubrano J. Delayed laparoscopic cholecystectomy increases the total hospital stay compared to an early laparoscopic cholecystectomy after acute cholecystitis: an updated meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Oct;17(10):857-62. doi: 10.1111/hpb.12449. Epub 2015 Jul 27.</citation>
    <PMID>26218858</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ayman El Nakeeb</investigator_full_name>
    <investigator_title>gastrointestinal surgical center, Mansoura University</investigator_title>
  </responsible_party>
  <keyword>Early laparoscopic cholecystectomy</keyword>
  <keyword>postcholecystectomy bile injury</keyword>
  <keyword>delay laparoscopic cholecystectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Acalculous Cholecystitis</mesh_term>
    <mesh_term>Cholecystitis, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>plan to make individual participant data (</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>6 months</ipd_time_frame>
    <ipd_access_criteria>elnakeebayman@yahoo.com</ipd_access_criteria>
    <ipd_url>http://www.mans.edu.eg/en/</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>Ayman El Nakeeb</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://www.mans.edu.eg/en/</doc_url>
      <doc_comment>elnakeebayman@yahoo.com</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT04405713
org study id: early LC for ACC
nct id: NCT04405713
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The ideal timing for ELC continues to be debatable in patients with acute calculator
      cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in
      ACC on surgical outcomes in terms of safety and efficacy
This multicentric analysis involved of successive patients with ACC ELC between April 2018
      and March 2020. Patients were divided into three groups according to the timing of the
      surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days
      (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of
      postoperative complications The secondary outcomes were conversion rate, blood loss,
      operative times, operational difficulty, the cost-benefit relationship, postoperative stay
      with each treatment line.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients with ACC were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).
measure: the incidence of postoperative morbidity
time frame: 30 DAYS
description: the incidence of postoperative morbidity during the 30th day of postoperative procedure
measure: conversion rate
time frame: INTRAOPERATIVE
description: conversion rate to open cholecystectomy
measure: blood loss
time frame: intraoperative
description: blood loss
measure: hospital stay
time frame: 30 days
description: overall hospital stay
arm group label: from the onset of symptoms within the first 3 days (group 1)
arm group type: Active Comparator
description: ELC for ACC from the onset of symptoms within the first 3 days (group 1)
arm group label: from the onset of symptoms within the 4-7 days
arm group type: Active Comparator
description: ELC for ACC from the onset of symptoms within the4-7 days (group II)
arm group label: from the onset of symptoms beyond 7 days
arm group type: Active Comparator
description: ELC for ACC from the onset of symptoms beyond 7 days (group III)
intervention type: Procedure
intervention name: from the onset of symptoms within the first 3 days
description: ELC within 3 days of onset of ACC
arm group label: from the onset of symptoms within the first 3 days (group 1)
other name: group 1
intervention type: Procedure
intervention name: : from the onset of symptoms within the 4-7 days
description: ELC 4-7days of onset of ACC
arm group label: from the onset of symptoms within the 4-7 days
other name: Group II
intervention type: Procedure
intervention name: from the onset of symptoms beyond 7 days
description: ELC after 7days of onset of ACC
arm group label: from the onset of symptoms beyond 7 days
other name: Group III
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ayman E Nakeeb
role: Principal Investigator
affiliation: Mansoura University, Gastrointestinal Surgery Center
facility: 
country: Egypt
url: http://www.mans.edu.eg/en/
description: Mansoura university
citation: El Zanati H, Nassar AHM, Zino S, Katbeh T, Ng HJ, Abdellatif A. Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes. JSLS. 2020 Apr-Jun;24(2):e2020.00015. doi: 10.4293/JSLS.2020.00015.
PMID: 32425482
citation: Mora-Guzman I, Di Martino M, Gancedo Quintana A, Martin-Perez E. Laparoscopic Cholecystectomy for Acute Cholecystitis: Is the Surgery Still Safe beyond the 7-Day Barrier? J Gastrointest Surg. 2020 Aug;24(8):1827-1832. doi: 10.1007/s11605-019-04335-5. Epub 2019 Aug 6. Erratum In: J Gastrointest Surg. 2021 Jan;25(1):337.
PMID: 31388885
citation: Brunee L, Hauters P, Closset J, Fromont G, Puia-Negelescu S; Club Coelio. Assessment of the optimal timing for early laparoscopic cholecystectomy in acute cholecystitis: a prospective study of the Club Coelio. Acta Chir Belg. 2019 Oct;119(5):309-315. doi: 10.1080/00015458.2018.1529344. Epub 2018 Oct 25.
PMID: 30354853
citation: Inoue K, Ueno T, Nishina O, Douchi D, Shima K, Goto S, Takahashi M, Shibata C, Naito H. Optimal timing of cholecystectomy after percutaneous gallbladder drainage for severe cholecystitis. BMC Gastroenterol. 2017 May 31;17(1):71. doi: 10.1186/s12876-017-0631-8.
PMID: 28569137
citation: Onoe S, Kaneoka Y, Maeda A, Takayama Y, Fukami Y. Feasibility of laparoscopic cholecystectomy for acute cholecystitis beyond 72 h of symptom onset. Updates Surg. 2016 Dec;68(4):377-383. doi: 10.1007/s13304-016-0409-5. Epub 2016 Oct 26.
PMID: 27785732
citation: Menahem B, Mulliri A, Fohlen A, Guittet L, Alves A, Lubrano J. Delayed laparoscopic cholecystectomy increases the total hospital stay compared to an early laparoscopic cholecystectomy after acute cholecystitis: an updated meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Oct;17(10):857-62. doi: 10.1111/hpb.12449. Epub 2015 Jul 27.
PMID: 26218858
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Ayman El Nakeeb
investigator title: gastrointestinal surgical center, Mansoura University
mesh term: Cholecystitis
mesh term: Acalculous Cholecystitis
mesh term: Cholecystitis, Acute
sharing ipd: Yes
ipd description: plan to make individual participant data (
ipd info type: Study Protocol
ipd time frame: 6 months
ipd access criteria: elnakeebayman@yahoo.com
ipd url: http://www.mans.edu.eg/en/
study doc: 