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

Study Overview
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Brief Summary
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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.

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

Conditions
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Appendicitis, Pain, Complications

Intervention / Treatment
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* Procedure: appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Appendicitis (clinical or radilogical diagnosis) ASA < 4 Exclusion Criteria: Appendicitis with palpable mass( clinical or radilogical diagnosis) Patient has bleeding tendency Pregnant

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one port<br>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<br>* appendectomy according to the number of trocar<br>|
| Active Comparator: Three ports<br>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<br>* appendectomy according to the number of trocar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain |  | For 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cosmetic effect |  | for 14days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, operative times, complication, time to return for normal life, pain using VAS score