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Completed

NCT Number: NCT06734494

Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis

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.

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Key information

Conditions

Peritonitis; Acute Acute Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Laparoscopy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Device

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

Primary outcomes

  1. Consumption of analgesics

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

    Number of medications taken during hospitalization

Secondary outcomes

  1. Length of stay

    Time frame: From the admission to the discharge home, up to 20 days

    Length of stay

  2. Operating Time

    Time frame: From beginning to end of surgery

    Time to operate the patients

  3. 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.

Sponsors and collaborators

Lead sponsor

Destinval Christelle

Other

Registry information

Official study title

Laparoscopic Appendectomy Using Airseal or a Standard Insufflator for Peritonitis in Children

Acronym: APPAS

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.

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