Low-Pressure Laparoscopy Using the AirSeal® System Versus Standard Insufflation in Appendicular Peritonitis in Children: a Monocentric Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Consumption of analgesics
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 4 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Consumption of analgesics
Time Frame: From the end of surgery to the discharge home, up to 20 days
number of medications taken during hospitalization
Secondary Outcomes
- Operating Time(From beginning to end of surgery)
- Mean Digital Pain Scale(Immediately after surgery until discharge home, up to 20 days)
- Length of stay(From the admission to the discharge home, up to 20 days)
Investigators
Dr Christelle DESTINVAL
Principal Investigator
University of Lorraine
