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

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ClinicalTrials.gov Identifier: NCT00816933
Recruitment Status : Unknown
Verified January 2009 by The Catholic University of Korea.
Recruitment status was:  Recruiting
First Posted : January 5, 2009
Last Update Posted : January 6, 2009
Sponsor:
Information provided by:
The Catholic University of Korea

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Appendicitis Pain Complications Procedure: appendectomy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
Study Start Date : January 2009
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. post-operative pain [ Time Frame: For 7days ]

Secondary Outcome Measures :
  1. cosmetic effect [ Time Frame: for 14days ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: January 5, 2009    Key Record Dates
Last Update Posted: January 6, 2009
Last Verified: January 2009

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

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases