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Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis

NCT ID: NCT06734494

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peritonitis; Acute Acute Appendicitis Postoperative Pain Laparoscopy

Keywords

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Valveless Trocar Low-pressure Insufflation Standard insufflation Laparoscopic Appendectomy Appendicular Peritonitis Retrospective Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Airseal group (A)

Patients who underwent a laparoscopic appendectomy using Airseal

Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Intervention Type DEVICE

Airseal is a constant and low-pressure insufflation device. Standard insufflation is a variable pressure insufflation device.

Standard group (S)

Patients who underwent a laparoscopic appendectomy using standard insufflation

Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Intervention Type DEVICE

Airseal is a constant and low-pressure insufflation device. Standard insufflation is a variable pressure insufflation device.

Interventions

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Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Airseal is a constant and low-pressure insufflation device. Standard insufflation is a variable pressure insufflation device.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 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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University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 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)

Rebuck DA, Zhao LC, Helfand BT, Casey JT, Navai N, Perry KT, Nadler RB. Simple modifications in operating room processes to reduce the times and costs associated with robot-assisted laparoscopic radical prostatectomy. J Endourol. 2011 Jun;25(6):955-60. doi: 10.1089/end.2010.0534. Epub 2011 Apr 2.

Reference Type BACKGROUND
PMID: 21457071 (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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M24DC1108

Identifier Type: -

Identifier Source: org_study_id

NCT05840419

Identifier Type: -

Identifier Source: nct_alias