Transumbilical Laparoscopy-assisted Appendectomy

Study Overview
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Brief Summary
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transumbilical laparoscopic-assisted appendectomy (TULAA) was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to conventional laparoscopic appendectomy (CLA) with three conventional ports in retrospective studies. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.

Detailed Description
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Single port appendectomy can be considered as the better option than conventional laparoscopic appendectomy (CLA) for pediatric patients with uncomplicated acute appendicitis in cosmetic aspect. However, this technique has not gained popularity because it has been regarded as a tricky and time-consuming procedure. Recently, the frequency of implementation of transumbilical laparoscopy-assisted appendectomy (TULAA) is increasing in pediatric patients with uncomplicated appendicitis. The reason that this operation is possible in children, is that the length between umbilicus and appendix is shorter than that of an adult, and the abdominal wall is flexible, so that the appendix can be extracted through umbilical incision. It was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to the laparoscopic appendectomy with three conventional ports. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.

Official Title
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Is Transumbilical Laparoscopy-assisted Appendectomy in the Pediatric Acute Uncomplicated Appendicitis Superior to Conventional 3 Port Laparoscopic Appendectomy?

Conditions
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Appendicitis Acute

Intervention / Treatment
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* Procedure: Transumbilical Laparoscopic-Assisted Appendectomy
* Procedure: 3-port laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinically diagnosed as acute appendicitis Age 18 or under Lab tests Hemoglobin ≥ 10g/dl White blood cell count ≥ 4,000/mm3 Platelet count ≥ 100,000/mm3 Creatinine ≤ 1.5 mg/dl Aspartate aminotransferase ≤ 100 IU/L Alanine aminotransferase ≤ 100 IU/L no significant dysfunction in the heart, lungs, kidneys. Exclusion Criteria: Previous abdominal operation Generalized peritonitis Anticipated extended resection Periappendiceal abscess on preoperative exam

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional group<br>conventional laparoscopic appendectomy with 3-ports | Procedure: 3-port laparoscopic appendectomy<br>* appendectomy performed intracorporeally with 3-port<br>|
| Experimental: TULAA group<br>An operator extracts and ligates appendix through umbilical port. | Procedure: Transumbilical Laparoscopic-Assisted Appendectomy<br>* appendectomy performed extracorporeally through umbilical port<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Time from skin incision to skin closure | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication rate | Rate of 30 day complication or in-hospital complication | 1 month | 
| postoperative hospital stay | postoperative hospital stay | 1 month |