Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis

Completed

• Conditions: Peritonitis; Acute; Appendicitis; Postoperative Pain; Surgery
• Interventions: Device: Laparoscopic appendectomy

• Registration Number: NCT05840419
• Lead Sponsor: Dr Christelle DESTINVAL

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-30
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-28
• Status Verified: 2023-05
• Study First Posted: 2023-05-03
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Airseal group (A)	Laparoscopic appendectomy	Patients operated with Airseal
Standard group (S)	Laparoscopic appendectomy	Patients operated with standard insufflation

Primary Outcome Measures

Name	Time	Method
Consumption of analgesics	From the end of surgery to the discharge home, up to 20 days	number of medications taken during hospitalization

Secondary Outcome Measures

Name	Time	Method
Mean Digital Pain Scale	Immediately after surgery until discharge home, up to 20 days	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.
Length of stay	From the admission to the discharge home, up to 20 days	Length of stay
Operating Time	From beginning to end of surgery	Time to operate the patients

Trial Locations

Locations (1)

ULorraine; 🇫🇷 Vandœuvre-lès-Nancy, Grand-Est, France