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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01348464
Other study ID # girba2339
Secondary ID
Status Completed
Phase N/A
First received April 29, 2011
Last updated April 2, 2012
Start date March 2010
Est. completion date December 2011

Study information

Verified date April 2012
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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


Description:

- primary objective

1. complication rate

- secondary objectives

1. satisfaction rate

2. pain scale difference


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 85 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
single port appendectomy, three port appendectomy
visual analog scale. questionnaire on wound satisfaction

Locations

Country Name City State
Korea, Republic of Gachon Univ., Gil Medical Center Incheon

Sponsors (1)

Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Raakow R, Jacob DA. Initial experience in laparoscopic single-port appendectomy: a pilot study. Dig Surg. 2011;28(1):74-9. doi: 10.1159/000322921. Epub 2011 Feb 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Complication rate observe complication caused by both procedures participants will be followed for the duration of hospital stay, an expected average of 24 weeks No
Secondary patient satisfaction 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 No
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