Trials / Completed
CompletedNCT06734494
Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis
Laparoscopic Appendectomy Using Airseal or a Standard Insufflator for Peritonitis in Children
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Destinval Christelle · Academic / Other
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Laparoscopic 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. |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2022-12-31
- Completion
- 2023-01-01
- First posted
- 2024-12-16
- Last updated
- 2024-12-16
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06734494. Inclusion in this directory is not an endorsement.