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A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

This study has been completed.
Information provided by (Responsible Party):
Won-Suk Lee, Gachon University Gil Medical Center Identifier:
First received: April 29, 2011
Last updated: April 2, 2012
Last verified: April 2012
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

Condition Intervention
Acute Appendicitis
Procedure: single port appendectomy, three port appendectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Complication rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks ]
    observe complication caused by both procedures

Secondary Outcome Measures:
  • patient satisfaction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks ]
    Questionarire is given to the patients on postoperative 3days, 1month, 3 months and 6 months

Enrollment: 150
Study Start Date: March 2010
Study Completion Date: December 2011
Groups/Cohorts Assigned Interventions
lifestyle, wound satisfaction
single site access three site access for appendectomy
Procedure: single port appendectomy, three port appendectomy
visual analog scale. questionnaire on wound satisfaction
Other Names:
  • Pain scale
  • Satisfactory score
  • complication rate

Detailed Description:
  • primary objective

    1. complication rate

  • secondary objectives

    1. satisfaction rate
    2. pain scale difference

Ages Eligible for Study:   5 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The cohorts will be the residents of Incheon, Korea

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.
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Please refer to this study by its identifier: NCT01348464

Korea, Republic of
Gachon Univ., Gil Medical Center
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Principal Investigator: Won-Suk Lee, MD Gachon Univ. Gil Medical Center
  More Information

Additional Information:
Responsible Party: Won-Suk Lee, Assistant prof, Gachon University Gil Medical Center Identifier: NCT01348464     History of Changes
Other Study ID Numbers: girba2339
Study First Received: April 29, 2011
Last Updated: April 2, 2012

Keywords provided by Gachon University Gil Medical Center:
laparoscopic surgery

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases processed this record on April 28, 2017