Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis (APPAS)

May 14, 2023 updated by: Dr Christelle DESTINVAL

Low-Pressure Laparoscopy Using the AirSeal® System Versus Standard Insufflation in Appendicular Peritonitis in Children: a Monocentric Retrospective Study

The AirSeal System Valve-less Trocar is known to decrease postoperative pain, consumption of analgesics, operating time, and length of stay in adults during robotic and laparoscopic procedures.

The investigators would like to know if these allegations also apply to children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From January the 1st 2022 to December the 31st 2022, 100 children aged under 18 years old had an appendicular peritonitis treated by laparoscopic appendectomy.

The pediatric surgeons either used the AirSeal System Valve-less Trocar or the standard insufflation.

On one hand, only the surgeon, the anesthetist and the nurses of the operating room knew which type of insufflation was used.

On the other hand, the patient, his parents and the nurses in the pediatric department did not know which type of insufflation was used.

The participants were divided in two groups: the Airseal group (A) and the standard group (S). In each group, the investigators studied and compared the postoperative pain, the consumption of analgesics, the operating time, and the length of stay for each participant.

Study Type

Observational

Enrollment (Actual)

100

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 aged between 4 and 17 years old, who underwent laparoscopic appendectomy for appendicular peritonitis using the Airseal® or a Standard Insufflation, from 2022/01/1st to 2022/12/31st.

Description

Inclusion Criteria:

  • Children aged between 4 and 17 years old
  • Who underwent laparoscopic appendectomy for appendicular peritonitis
  • Between 2022/06/1st and 2022/12/31st

Exclusion Criteria:

  • Children younger than 4 years old or older than 18 years old
  • Who did not have appendicular peritonitis
  • Between 2022/01/1st and 2022/12/31st

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
Intervention / Treatment
Airseal group (A)
Patients operated with Airseal
Device: Laparoscopic appendectomy
Laparoscopic appendectomy with Airseal or with standard insufflation
Standard group (S)
Patients operated with standard insufflation
Device: Laparoscopic appendectomy
Laparoscopic appendectomy with Airseal or with standard insufflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of analgesics
Time Frame: From the end of surgery to the discharge home, up to 20 days
number of medications taken during hospitalization
From the end of surgery to the discharge home, up to 20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: From the admission to the discharge home, up to 20 days
Length of stay
From the admission to the discharge home, up to 20 days
Operating Time
Time Frame: From beginning to end of surgery
Time to operate the patients
From beginning to end of surgery
Mean Digital Pain Scale
Time Frame: Immediately after surgery until 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.
Immediately after surgery until discharge home, up to 20 days

Collaborators and Investigators

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

Sponsor

Dr Christelle DESTINVAL

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, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 3, 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

  • ULor
  • 2023PI006 (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 Postoperative Pain

Clinical Trials on Laparoscopic appendectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe