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A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

G

Gachon University Gil Medical Center

Status

Completed

Conditions

Acute Appendicitis

Treatments

Procedure: single port appendectomy, three port appendectomy

Study type

Observational

Funder types

Other

Identifiers

NCT01348464
girba2339

Details and patient eligibility

About

The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial

Full description

  • primary objective

    1. complication rate
  • secondary objectives

    1. satisfaction rate
    2. pain scale difference

Enrollment

150 patients

Sex

All

Ages

5 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 5~85 years
  • any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT
  • Patient performance status(PS) with greater than 80 or more on Karnofsky PS
  • Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion criteria

  • Pregnant or lactating
  • Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
  • History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer
  • Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.

Trial design

150 participants in 1 patient group

lifestyle, wound satisfaction
Description:
single site access three site access for appendectomy
Treatment:
Procedure: single port appendectomy, three port appendectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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