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Single Incision Versus Conventional Laparoscopic Appendectomy

Primary Purpose

Appendicitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Single Incision Laparoscopic Appendectomy
Conventional appendectomy
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patients with suspected acute appendicitis

Exclusion Criteria:

  • Perforated appendicitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Single Incision Laparoscopic Appendectomy

    Conventional appendectomy

    Arm Description

    Conventional appendectomy

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2012
    Last Updated
    January 23, 2012
    Sponsor
    Hospital Universitario Virgen de la Arrixaca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01515293
    Brief Title
    Single Incision Versus Conventional Laparoscopic Appendectomy
    Official Title
    Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario Virgen de la Arrixaca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.
    Detailed Description
    Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appendicitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    184 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Incision Laparoscopic Appendectomy
    Arm Type
    Experimental
    Arm Title
    Conventional appendectomy
    Arm Type
    Experimental
    Arm Description
    Conventional appendectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Single Incision Laparoscopic Appendectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional appendectomy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Eligibility Criteria
    Inclusion Criteria: Patients with suspected acute appendicitis Exclusion Criteria: Perforated appendicitis

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23386239
    Citation
    Frutos MD, Abrisqueta J, Lujan J, Abellan I, Parrilla P. Randomized prospective study to compare laparoscopic appendectomy versus umbilical single-incision appendectomy. Ann Surg. 2013 Mar;257(3):413-8. doi: 10.1097/SLA.0b013e318278d225.
    Results Reference
    derived

    Learn more about this trial

    Single Incision Versus Conventional Laparoscopic Appendectomy

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