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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00816933
Other study ID # HFHAPPE 01
Secondary ID
Status Recruiting
Phase Phase 1
First received January 2, 2009
Last updated January 5, 2009
Start date January 2009
Est. completion date January 2010

Study information

Verified date January 2009
Source The Catholic University of Korea
Contact Wook Kim, professor
Phone +82-32-340-7022
Email kimwook@catholic.ac.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Appendicitis is the most common benign inflammatory disease that requires an operation.

Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 75 Years
Eligibility Inclusion Criteria:

- Appendicitis (clinical or radilogical diagnosis)

- ASA < 4

Exclusion Criteria:

- Appendicitis with palpable mass( clinical or radilogical diagnosis)

- Patient has bleeding tendency

- Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
appendectomy
appendectomy according to the number of trocar

Locations

Country Name City State
Korea, Republic of Dept. of Surgery, Holy Family Hospital, College of Medicine, The Catholic University of Korea Bucheon Gyunggi Do

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary post-operative pain For 7days No
Secondary cosmetic effect for 14days No
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