Laparoscopic Cholecystectomy Using Airseal in Children

Laparoscopy Using the Airseal System Versus Standard Insufflation in Cholecystectomy in Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06734507

Acronym

VBAS

Enrollment

Registered

2024-12-16

Start date

2022-01-01

Completion date

2023-01-01

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Only, Cholecystitis, Gall Stones (& [Calculus - Gall Bladder]), Pancreatitis Due to Gallstones

Keywords

Laparoscopy, Cholecystectomy, Airseal, Valveless Trocar, Standard Insufflation, Retrospective Study

Brief summary

The goal of this observational study is to compare the use of Airseal versus a standard insufflation, in children who underwent laparoscopic cholecystectomy, between January 2021 and December 2022. The main questions it aims to answer are: * amount of analgesics consumed postoperatively * mean digital pain scale Data are directly extracted from patients medical files. The investigators will compare the Airseal group (A group) to the Standard insufflation group (S group) to see if the A group consumes significatively less analgesics and are less painful than the S group.

Detailed description

Choosing to enter the A or the S group depends on the surgeon's choice. Only the surgeon, the anesthetic and the nurses in the operating room know which type of insufflation has been chosen.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Patients aged under 18 years old * Who underwent laparoscopic cholecystectomy * From January 2021 to December 2022

Exclusion criteria

* Patients older than 18 years old

Design outcomes

Primary

Measure	Time frame	Description
Amount of analgesics consumed	From the end of surgery to the discharge home, up to 20 days	Number of takings postoperatively
Mean Digital Pain Scale	From the end of surgery to the 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.

Secondary

Measure	Time frame	Description
Histological results	Between 2 weeks and 4 weeks after surgery	Analysis of the gall bladder after removal
Operating time	Perioperatively	Time-length of surgery
Anesthetic time	Perioperatively	Time-length of anesthesia
Length of stay	From the day of hospitalization to the day of discharge home, up to 20 days	Hospital length of stay

Countries

France

Outcome results