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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
History of Changes
  Purpose

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
Appendicitis
Pain
Complications
 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:

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

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

  Eligibility
Ages Eligible for Study:   8 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816933

Contacts
Contact: Wook Kim, professor +82-32-340-7022 kimwook@catholic.ac.kr
Contact: Junhyun Lee, Instructor +82-32-340-7026 surgeryjun@catholi.ac.kr

Locations
Korea, Republic of
Dept. of Surgery, Holy Family Hospital, College of Medicine, The Catholic University of Korea Recruiting
Bucheon, Gyunggi Do, Korea, Republic of, 420-717
Contact: Wook Kim, professor    +82-32-340-7022    kimwook@catholic.ac.kr   
Contact: Junhyun Lee, Instructor    +82-32-340-7026    surgeryjun@catholic.ac.kr   
Principal Investigator: Wook Kim, professor         
Sub-Investigator: Dongjae Kim, professor         
Sub-Investigator: Junhyun Lee, Instructor         
Sponsors and Collaborators
The Catholic University of Korea
  More Information

No publications provided by The Catholic University of Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wook Kim. MD, PhD, Professor & Chief
ClinicalTrials.gov 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:
pain
operative times
complication
time to return for normal life
pain using VAS score

ClinicalTrials.gov processed this record on March 02, 2015