Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis

NCT06734494 | Completed

• 1 other identifier: M24DC1108
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peritonitis; Acute; Acute Appendicitis; Postoperative Pain; Laparoscopy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Consumption of analgesics

  Number of medications taken during hospitalization

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

Secondary Outcomes (3)

• Length of stay

  From the admission to the discharge home, up to 20 days

• Operating Time

  From beginning to end of surgery

• Mean Digital Pain Scale

  Immediately after surgery until discharge home, up to 20 days

Study Arms (2)

Airseal group (A)

Patients who underwent a laparoscopic appendectomy using Airseal

Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Standard group (S)

Patients who underwent a laparoscopic appendectomy using standard insufflation

Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation

Interventions

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.

Airseal group (A); Standard group (S)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Destinval Christelle: lead

Study Sites (1)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (3)

• 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.

  PMID: 24503370 BACKGROUND

• 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.

  PMID: 21457071 BACKGROUND

• 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.

  PMID: 30159821 BACKGROUND

MeSH Terms

Conditions

Peritonitis; Appendicitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)