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Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis (APPAS)

D

Destinval Christelle

Status

Completed

Conditions

Postoperative Pain
Laparoscopy
Acute Appendicitis
Peritonitis; Acute

Treatments

Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Study type

Observational

Funder types

Other

Identifiers

NCT06734494
M24DC1108

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Airseal group (A)
Description:
Patients who underwent a laparoscopic appendectomy using Airseal
Treatment:
Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation
Standard group (S)
Description:
Patients who underwent a laparoscopic appendectomy using standard insufflation
Treatment:
Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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