Homemade Versus Commercialized Single-access Port Devices in Single-incision Laparoscopic Appendectomy

Study Overview
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Brief Summary
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Homemade and commercialized single-assess port devices are two kinds of port devices commonly used for single-incision laparoscopic appendectomy. This study aimed to compare these two port devices in terms of short-term surgical outcomes and medical costs.

Detailed Description
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The advantages of homemade port devices include accessibility of the composites and lower equipment costs to the patients; however, the potential disadvantage is the easy leakage of CO2, ballooning of the surgical glove, and device instability, leading to difficult maneuverability. On the other hand, commercialized port devices have relatively easy maneuverability, flexibility for instrument changes, and port stability for long-duration surgery ; however, their higher equipment cost is a disadvantage.

Official Title
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Comparison of Homemade Versus Commercialized Single-access Port Devices for Single-incision Laparoscopic Appendectomy: A Retrospective Comparative Study

Conditions
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Minimally Invasive Surgical Procedures

Intervention / Treatment
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* Procedure: Commercialized single-access port devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients were diagnosed as acute appendicitis and undergoing single-incision laparoscopic appendectomy Exclusion Criteria: The patient was not diagnosed as acute appendicitis based on surgical finding or pathological findings The patients underwent surgery other than single-incision laparoscopic surgery

Ages Eligible for Study
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Minimum Age: 9 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Handmade single-access port device<br>The homemade single-access device was composed of a wound protector, sterile surgical glove, and three trocars inserted into and secured over three digits of the glove | |
| Commercialized single-access port devices<br>Commercialized single-access port devices including GelPOINT® (Applied Medical, Rancho Santa Margarita, CA, USA) and LAGIPORT® (LAGIS, Taichung, Taiwan) | Procedure: Commercialized single-access port devices<br>* Two kinds of commercialized single-access port devices were used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total surgical complications | Complications were defined by Clavien-Dindo classification and comprehensive complication index. | Complications happened within 30 days | 
| Superficial incisional surgical site infection (SSI) | SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification | Complications happened within 30 days | 
| Deep/organ SSI | SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification | Complications happened within 30 days | 
| Postoperative ileus | Postoperative ileus was defined as the presence of symptoms and signs of abdominal distention, nausea, or vomiting combined with abdominal radiography, such as plain radiography or CT, within 30 days after SILA. | Complications happened within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time | Total time needed for completing surgery | Time from skin incision to application of gauzes | 
| Time to resume soft diet | Total time needed to resume bowel ability to resuming soft diet | The time to resume a soft diet was measured as the duration between the time leaving the recovery room and the time to resume a soft diet recorded in the nursing note. | 
| Postoperative length of hospitalization | Total time to stay in hospital | Postoperative LOH was defined as the duration between leaving the recovery room and discharge. | 
| Total medical costs | Medical costs were defined as the medical fees paid by the National Health Insurance and did not include the self-paid equipment fees needed in SILA (e.g., commercialized single-access port devices, or wound protector). | From the time patient being brought to emergency room to the time patient being discharged | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single-incision laparoscopic appendectomy, Single-access port device