A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

Sponsor

Gachon University Gil Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01348464

Collaborator

(none)

150

Enrollment

Location

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Appendicitis	Procedure: single port appendectomy, three port appendectomy

Detailed Description

primary objective

complication rate

secondary objectives

satisfaction rate
pain scale difference

Study Design

Study Type:

Observational

Actual Enrollment :

150 participants

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

Study Start Date :

Mar 1, 2010

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.