A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

April 2, 2012 updated by: Won-Suk Lee, Gachon University Gil Medical Center

Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • primary objective

    1. complication rate

  • secondary objectives

    1. satisfaction rate
    2. pain scale difference

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The cohorts will be the residents of Incheon, Korea

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

  • Principal Investigator: Won-Suk Lee, MD, Gachon Univ. Gil Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (ESTIMATE)

May 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 2, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • girba2339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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