Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis

Study Overview
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Brief Summary
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The AirSeal System Valve-less Trocar is known to decrease postoperative pain, consumption of analgesics, operating time, and length of stay in adults during robotic and laparoscopic procedures. The investigators would like to know if these allegations also apply to children.

Detailed Description
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From January the 1st 2022 to December the 31st 2022, 100 children aged under 18 years old had an appendicular peritonitis treated by laparoscopic appendectomy. The pediatric surgeons either used the AirSeal System Valve-less Trocar or the standard insufflation. On one hand, only the surgeon, the anesthetist and the nurses of the operating room knew which type of insufflation was used. On the other hand, the patient, his parents and the nurses in the pediatric department did not know which type of insufflation was used. The participants were divided in two groups: the Airseal group (A) and the standard group (S). In each group, the investigators studied and compared the postoperative pain, the consumption of analgesics, the operating time, and the length of stay for each participant.

Official Title
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Low-Pressure Laparoscopy Using the AirSeal® System Versus Standard Insufflation in Appendicular Peritonitis in Children: a Monocentric Retrospective Study

Conditions
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Peritonitis; Acute, Appendicitis, Postoperative Pain, Surgery

Intervention / Treatment
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* Device: Laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 4 and 17 years old Who underwent laparoscopic appendectomy for appendicular peritonitis Between 2022/06/1st and 2022/12/31st Exclusion Criteria: Children younger than 4 years old or older than 18 years old Who did not have appendicular peritonitis Between 2022/01/1st and 2022/12/31st

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 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 |
| --- | --- |
| Airseal group (A)<br>Patients operated with Airseal | Device: Laparoscopic appendectomy<br>* Laparoscopic appendectomy with Airseal or with standard insufflation<br>|
| Standard group (S)<br>Patients operated with standard insufflation | Device: Laparoscopic appendectomy<br>* Laparoscopic appendectomy with Airseal or with standard insufflation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of analgesics | number of medications taken during hospitalization | From the end of surgery to the discharge home, up to 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of stay | From the admission to the discharge home, up to 20 days | 
| Operating Time | Time to operate the patients | From beginning to end of surgery | 
| Mean Digital Pain Scale | Digital Pain Scale: minimum is 0 out of 10 (which means no pain) and maximum is 10 out of 10 (which means very painful). Higher scores mean worse outcomes. | Immediately after surgery until discharge home, up to 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valve-less Trocar, Standard insufflation, Prospective study, Laparoscopic Appendectomy, Appendicular Peritonitis