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A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348464
First Posted: May 5, 2011
Last Update Posted: April 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Won-Suk Lee, Gachon University Gil Medical Center
  Purpose
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 Won-Suk Lee, 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
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348464


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

Additional Information:
Publications:
Responsible Party: Won-Suk Lee, Assistant prof, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01348464     History of Changes
Other Study ID Numbers: girba2339
First Submitted: April 29, 2011
First Posted: May 5, 2011
Last Update Posted: April 4, 2012
Last Verified: April 2012

Keywords provided by Won-Suk Lee, Gachon University Gil Medical Center:
appendectomy
appendicitis
laparoscopic surgery

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases