<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/NCT03267082</url>
  </required_header>
  <id_info>
    <org_study_id>ERLMPA</org_study_id>
    <nct_id>NCT03267082</nct_id>
  </id_info>
  <brief_title>Evaluation the Role of Laparoscopic Management of Perforated Appendicitis</brief_title>
  <official_title>Evaluation the Role of Laparoscopic Management of Perforated Appendicitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its&#xD;
      advantages, such as the aesthetic appearance of the wound, less postoperative pain, and&#xD;
      faster recovery which facilitates early discharge, have been highlighted, and the number of&#xD;
      procedures performed has been continuously increasing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its&#xD;
      safety when it was first introduced. However, the application of the procedure has been&#xD;
      extended to complicated appendicitis (CA), and it is now considered as an alternative&#xD;
      procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it&#xD;
      is still controversial because there are still concerns about surgical difficulties in&#xD;
      managing CA with laparoscopy, overall surgery time, possible post-op complications and&#xD;
      conversion to an OA during the surgery.&#xD;
&#xD;
      this study aimed to evaluate the safety and the efficacy of LA for managing perforated&#xD;
      appendicitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2017</start_date>
  <completion_date type="Anticipated">March 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>early recovery</measure>
    <time_frame>2 day</time_frame>
    <description>recovery within 2 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>wound cosmetic appearance</measure>
    <time_frame>6 months</time_frame>
    <description>no scare of incision post laporscopic mangement</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Perforated Appendicitis</condition>
  <arm_group>
    <arm_group_label>Evaluation the role of Laparoscopic management of perforated a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laparoscopic management of perforated appendicitis</intervention_name>
    <description>Insertion of Ports&#xD;
Exposure of the Appendix&#xD;
peritoneal toilet and aspiration of pus after abdominal exposure&#xD;
Isolation of Mesoappendicular Artery&#xD;
Clipping and Dividing of the Artery&#xD;
Application of 3 x Endoloops&#xD;
Division of the Appendix&#xD;
Retrieval of the Appendix in an Endobag</description>
    <arm_group_label>Evaluation the role of Laparoscopic management of perforated a</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of acute perforated appendicitis&#xD;
&#xD;
          -  fit for laparoscopy and general anesthesia.&#xD;
&#xD;
          -  written informed consent.&#xD;
&#xD;
          -  short term outcome data and agree to provide contact information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  high risk for general anesthesia.&#xD;
&#xD;
          -  Appendicular abscess and appendicular mass .&#xD;
&#xD;
          -  ongoing infections including chest infections .&#xD;
&#xD;
          -  Children and pregnant females .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.</citation>
    <PMID>6221925</PMID>
  </results_reference>
  <results_reference>
    <citation>Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010.</citation>
    <PMID>8624197</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 27, 2017</last_update_submitted>
  <last_update_submitted_qc>August 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>samir hosny mahmoud mohamed</investigator_full_name>
    <investigator_title>general surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03267082
org study id: ERLMPA
nct id: NCT03267082
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its
      advantages, such as the aesthetic appearance of the wound, less postoperative pain, and
      faster recovery which facilitates early discharge, have been highlighted, and the number of
      procedures performed has been continuously increasing.
The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its
      safety when it was first introduced. However, the application of the procedure has been
      extended to complicated appendicitis (CA), and it is now considered as an alternative
      procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it
      is still controversial because there are still concerns about surgical difficulties in
      managing CA with laparoscopy, overall surgery time, possible post-op complications and
      conversion to an OA during the surgery.

      this study aimed to evaluate the safety and the efficacy of LA for managing perforated
      appendicitis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: early recovery
time frame: 2 day
description: recovery within 2 days
measure: wound cosmetic appearance
time frame: 6 months
description: no scare of incision post laporscopic mangement
arm group label: Evaluation the role of Laparoscopic management of perforated a
arm group type: Experimental
intervention type: Other
intervention name: Laparoscopic management of perforated appendicitis
description: Insertion of Ports
Exposure of the Appendix
peritoneal toilet and aspiration of pus after abdominal exposure
Isolation of Mesoappendicular Artery
Clipping and Dividing of the Artery
Application of 3 x Endoloops
Division of the Appendix
Retrieval of the Appendix in an Endobag
arm group label: Evaluation the role of Laparoscopic management of perforated a
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.
PMID: 6221925
citation: Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010.
PMID: 8624197
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: samir hosny mahmoud mohamed
investigator title: general surgery
mesh term: Appendicitis
sharing ipd: Undecided