Laparoscopic Cholecystectomy Using Airseal in Children (VBAS)

May 14, 2023 updated by: Dr Christelle DESTINVAL, University of Lorraine

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Grand-Est
      • Vandœuvre-lès-Nancy, Grand-Est, France, 54500
        • ULorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients adressed to the University Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
A Group
Group of patient who underwent laparoscopic cholecystectomy using Airseal
S Group
Group of patient who underwent laparoscopic cholecystectomy using a standard insufflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of analgesics consumed
Time Frame: From the end of surgery to the discharge home, up to 20 days
Number of takings postoperatively
From the end of surgery to the discharge home, up to 20 days
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.
From the end of surgery to the discharge home, , up to 20 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lorraine

Investigators

  • Principal Investigator: Christelle Destinval, MD, University of Lorraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 13, 2023

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULo
  • 2023PI010 (Registry Identifier: DRCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the name of anonymization we won't share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholecystitis, Acute

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe