Clinical trial NCT06734494: Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis
Official title: Laparoscopic Appendectomy Using Airseal or a Standard Insufflator for Peritonitis in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritonitis; Acute
Acute Appendicitis
Postoperative Pain
Laparoscopy
Keywords: Valveless Trocar
Low-pressure Insufflation
Standard insufflation
Laparoscopic Appendectomy
Appendicular Peritonitis
Retrospective Study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Consumption of analgesics
timeFrame: From the end of surgery to the discharge home, up to 20 days
Secondary outcomes:
measure: Length of stay
timeFrame: From the admission to the discharge home, up to 20 days
measure: Operating Time
timeFrame: From beginning to end of surgery
measure: Mean Digital Pain Scale
timeFrame: Immediately after surgery until discharge home, up to 20 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital, Clermont-Ferrand
state: Auvergne
Study officials:
References:
citation: Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
citation: Rebuck DA, Zhao LC, Helfand BT, Casey JT, Navai N, Perry KT, Nadler RB. Simple modifications in operating room processes to reduce the times and costs associated with robot-assisted laparoscopic radical prostatectomy. J Endourol. 2011 Jun;25(6):955-60. doi: 10.1089/end.2010.0534. Epub 2011 Apr 2.
citation: de'Angelis N, Petrucciani N, Giannandrea G, Brunetti F. The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum. Updates Surg. 2018 Dec;70(4):553-556. doi: 10.1007/s13304-018-0591-8. Epub 2018 Aug 29.