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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by The Catholic University of Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00816933
First received: January 2, 2009
Last updated: January 5, 2009
Last verified: January 2009

January 2, 2009
January 5, 2009
January 2009
January 2010   (final data collection date for primary outcome measure)
post-operative pain [ Time Frame: For 7days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00816933 on ClinicalTrials.gov Archive Site
cosmetic effect [ Time Frame: for 14days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Appendicitis
  • Pain
  • Complications
Procedure: appendectomy
appendectomy according to the number of trocar
  • Experimental: one port
    Patients undergo one port appectomy. Skin incision about 2cm size is made upon umbilicus and dissection is performed to make opening. Then, wound retractcor(Alexis) is iserted on opening site and wound is extended. Rubber glove built-in three 5mm trocars is applied over wound retractor. Pneumoperitoneum is achieved via trocar and appendectomy is performed. After appendectomy, wound is repaired.
    Intervention: Procedure: appendectomy
  • Active Comparator: Three ports

    Paitents will undergo three port appendectomy. 10 mm trocar is inserted on umbilicus, and two 5mm trocas is inserted low abdomen, left flank respectively.

    Appendectomy is performed vis these trocas. After operation, wounds are repaired.

    Intervention: Procedure: appendectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Appendicitis (clinical or radilogical diagnosis)
  • ASA < 4

Exclusion Criteria:

  • Appendicitis with palpable mass( clinical or radilogical diagnosis)
  • Patient has bleeding tendency
  • Pregnant
Both
8 Years to 75 Years
No
Contact: Wook Kim, professor +82-32-340-7022 kimwook@catholic.ac.kr
Contact: Junhyun Lee, Instructor +82-32-340-7026 surgeryjun@catholi.ac.kr
Korea, Republic of
 
NCT00816933
HFHAPPE 01
Yes
Wook Kim. MD, PhD, Professor & Chief
The Catholic University of Korea
Not Provided
Not Provided
The Catholic University of Korea
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP