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Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis

Laparoscopic Appendectomy Using Airseal or a Standard Insufflator for Peritonitis in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06734494
Acronym
APPAS
Enrollment
100
Registered
2024-12-16
Start date
2022-01-01
Completion date
2023-01-01
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Appendicitis, Laparoscopy, Peritonitis; Acute, Postoperative Pain

Keywords

Valveless Trocar, Low-pressure Insufflation, Standard insufflation, Laparoscopic Appendectomy, Appendicular Peritonitis, Retrospective Study

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.

Interventions

DEVICELaparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Airseal is a constant and low-pressure insufflation device. Standard insufflation is a variable pressure insufflation device.

Sponsors

Destinval Christelle
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Consumption of analgesicsFrom the end of surgery to the discharge home, up to 20 daysNumber of medications taken during hospitalization

Secondary

MeasureTime frameDescription
Length of stayFrom the admission to the discharge home, up to 20 daysLength of stay
Operating TimeFrom beginning to end of surgeryTime to operate the patients
Mean Digital Pain ScaleImmediately after surgery until discharge home, up to 20 daysDigital 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026