Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy

Pain Clinical Trial

Official title:

Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00816933
• Other study ID #: HFHAPPE 01
• 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

• Appendicitis
• Complications
• Pain

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