Laparoscopic Cholecystectomy Using Airseal in Children

Completed

• Conditions: Cholecystitis, Chronic; Cholecystitis, Acute; Pancreatitis Due to Gallstones; Gall Stones (& [Calculus - Gall Bladder]); Child, Only

• Registration Number: NCT05848726
• Lead Sponsor: University of Lorraine

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study First Submitted: 2023-04-12
• Study Completion: 2023-04-13
• Study First Submitted QC: 2023-04-28
• Status Verified: 2023-05
• Study First Posted: 2023-05-08
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

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