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Evaluation the Role of Laparoscopic Management of Perforated Appendicitis

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ClinicalTrials.gov Identifier: NCT03267082
Recruitment Status : Unknown
Verified August 2017 by samir hosny mahmoud mohamed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
samir hosny mahmoud mohamed, Assiut University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Perforated Appendicitis Other: Laparoscopic management of perforated appendicitis Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Role of Laparoscopic Management of Perforated Appendicitis
Estimated Study Start Date : September 15, 2017
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Evaluation the role of Laparoscopic management of perforated a Other: Laparoscopic management of perforated appendicitis
  1. Insertion of Ports
  2. Exposure of the Appendix
  3. peritoneal toilet and aspiration of pus after abdominal exposure
  4. Isolation of Mesoappendicular Artery
  5. Clipping and Dividing of the Artery
  6. Application of 3 x Endoloops
  7. Division of the Appendix
  8. Retrieval of the Appendix in an Endobag


Outcome Measures
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Primary Outcome Measures :
  1. early recovery [ Time Frame: 2 day ]
    recovery within 2 days


Secondary Outcome Measures :
  1. wound cosmetic appearance [ Time Frame: 6 months ]
    no scare of incision post laporscopic mangement


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute perforated appendicitis
  • fit for laparoscopy and general anesthesia.
  • written informed consent.
  • short term outcome data and agree to provide contact information.

Exclusion Criteria:

  • high risk for general anesthesia.
  • Appendicular abscess and appendicular mass .
  • ongoing infections including chest infections .
  • Children and pregnant females .
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications of Results:

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Responsible Party: samir hosny mahmoud mohamed, general surgery, Assiut University
ClinicalTrials.gov Identifier: NCT03267082    
Other Study ID Numbers: ERLMPA
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infections
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases