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Clinical Trials/NCT05840419
NCT05840419CompletedNot Applicable

Low-Pressure Laparoscopy Using the AirSeal® System Versus Standard Insufflation in Appendicular Peritonitis in Children: a Monocentric Retrospective Study

Dr Christelle DESTINVAL1 site in 1 country100 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Consumption of analgesics

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
4 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Consumption of analgesics

Time Frame: From the end of surgery to the discharge home, up to 20 days

number of medications taken during hospitalization

Secondary Outcomes

  • Operating Time(From beginning to end of surgery)
  • Mean Digital Pain Scale(Immediately after surgery until discharge home, up to 20 days)
  • Length of stay(From the admission to the discharge home, up to 20 days)

Investigators

Sponsor
Dr Christelle DESTINVAL
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Christelle DESTINVAL

Principal Investigator

University of Lorraine

Study Sites (1)

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