A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

Completed

• Conditions: Acute Appendicitis
• Interventions: Procedure: single port appendectomy, three port appendectomy

• Registration Number: NCT01348464
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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

Detailed Description

* primary objective

1. complication rate

* secondary objectives

1. satisfaction rate

2. pain scale difference

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Study Completion: 2011-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-02
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lifestyle, wound satisfaction	single port appendectomy, three port appendectomy	single site access three site access for appendectomy

Primary Outcome Measures

Name	Time	Method
Complication rate	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

Name	Time	Method
patient satisfaction	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

Trial Locations

Locations (1)

Gachon Univ., Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of