Laparoscopic Cholecystectomy Using Airseal in Children

NCT ID: NCT06734507

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Gall Stones (& [Calculus - Gall Bladder]) Cholecystitis Pancreatitis Due to Gallstones Child, Only

Keywords

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Laparoscopy Cholecystectomy Airseal Valveless Trocar Standard Insufflation Retrospective Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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A Group

Group of patient who underwent laparoscopic cholecystectomy using Airseal

No interventions assigned to this group

S Group

Group of patient who underwent laparoscopic cholecystectomy using a standard insufflator

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Destinval Christelle

OTHER

Sponsor Role lead

Responsible Party

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Destinval Christelle

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Clermont-Ferrand University Hospital

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.

Reference Type BACKGROUND
PMID: 24503370 (View on PubMed)

de'Angelis N, Petrucciani N, Giannandrea G, Brunetti F. The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum. Updates Surg. 2018 Dec;70(4):553-556. doi: 10.1007/s13304-018-0591-8. Epub 2018 Aug 29.

Reference Type BACKGROUND
PMID: 30159821 (View on PubMed)

Other Identifiers

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M24DC1109

Identifier Type: -

Identifier Source: org_study_id

NCT05848726

Identifier Type: -

Identifier Source: nct_alias