Skip to main content
OpenTrials
Completed

NCT Number: NCT06734507

Laparoscopic Cholecystectomy Using Airseal in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gall Stones (& [Calculus - Gall Bladder]) Biliary Tract Diseases Calculi Child, Only Cholecystitis Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pancreatitis Due to Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Amount of analgesics consumed

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

    Number of takings postoperatively

  2. Mean Digital Pain Scale

    Time frame: 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 outcomes

  1. Operating time

    Time frame: Perioperatively

    Time-length of surgery

  2. Anesthetic time

    Time frame: Perioperatively

    Time-length of anesthesia

  3. Length of stay

    Time frame: From the day of hospitalization to the day of discharge home, up to 20 days

    Hospital length of stay

  4. Histological results

    Time frame: Between 2 weeks and 4 weeks after surgery

    Analysis of the gall bladder after removal

Sponsors and collaborators

Lead sponsor

Destinval Christelle

Other

Registry information

Official study title

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

Acronym: VBAS

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.