VBAS: Laparoscopic Cholecystectomy Using Airseal in Children

Sponsor

University of Lorraine (Other)

Overall Status

Completed

CT.gov ID

NCT05848726

Collaborator

(none)

Enrollment

Location

27.3

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gall Stones (& [Calculus - Gall Bladder]) Cholecystitis, Acute Cholecystitis, Chronic Pancreatitis Due to Gallstones Child, Only

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.

Study Design

Study Type:

Observational

Actual Enrollment :

23 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Low-Pressure Laparoscopy Using the Airseal System Versus Standard Insufflation in Cholecystectomy in Children: A Monocentric Retrospective Study

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Apr 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
A Group Group of patient who underwent laparoscopic cholecystectomy using Airseal
S Group Group of patient who underwent laparoscopic cholecystectomy using a standard insufflation

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
Histological results [between 2 weeks and 4 weeks after surgery]
Analysis of the gall bladder after removal