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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. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by The Catholic University of Korea.
Recruitment status was:  Recruiting
Information provided by:
The Catholic University of Korea Identifier:
First received: January 2, 2009
Last updated: January 5, 2009
Last verified: January 2009

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.

Condition Intervention Phase
Procedure: appendectomy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy

Resource links provided by NLM:

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • post-operative pain [ Time Frame: For 7days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cosmetic effect [ Time Frame: for 14days ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: appendectomy
appendectomy according to the number of trocar
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.

Procedure: appendectomy
appendectomy according to the number of trocar


Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Appendicitis with palpable mass( clinical or radilogical diagnosis)
  • Patient has bleeding tendency
  • Pregnant
  Contacts and Locations
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Please refer to this study by its identifier: NCT00816933

Korea, Republic of
Dept. of Surgery, Holy Family Hospital, College of Medicine, The Catholic University of Korea
Bucheon, Gyunggi Do, Korea, Republic of, 420-717
Sponsors and Collaborators
The Catholic University of Korea
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wook Kim. MD, PhD, Professor & Chief Identifier: NCT00816933     History of Changes
Other Study ID Numbers: HFHAPPE 01 
Study First Received: January 2, 2009
Last Updated: January 5, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:
operative times
time to return for normal life
pain using VAS score

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases processed this record on December 08, 2016