An observational study in Peritonitis; Acute, Acute Appendicitis and Postoperative Pain, sponsored by Destinval Christelle. Completed at 1 site in France. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Destinval Christelle · Observational
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.
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's enrollment of 100 is below the median of 137 across 55 observational studies indexed under Peritonitis.
Browse Peritonitis studies →Destinval Christelle is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged between 4 and 17 years old who underwent laparoscopic appendectomy for appendicular peritonitis using the Airseal® or a Standard Insufflation, from 2022/01/1st to 2022/12/31st.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who underwent a laparoscopic appendectomy using Airseal
Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation
Patients who underwent a laparoscopic appendectomy using standard insufflation
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.
Consumption of analgesics
Number of medications taken during hospitalization
Time frame: From the end of surgery to the discharge home, up to 20 days
Length of stay
Length of stay
Time frame: From the admission to the discharge home, up to 20 days
Operating Time
Time to operate the patients
Time frame: 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.
Time frame: Immediately after surgery until discharge home, up to 20 days
Plan to share: No — In the name of anonymization we won't share individual participant data
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Destinval Christelle