Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis

Surgery Clinical Trial

— APPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840419
• Other study ID #: ULor
• Secondary ID: 2023PI006
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2023
• Source: University of Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Peritonitis
• Postoperative Pain
• Surgery

Intervention

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

Locations

Country	Name	City	State
France	ULorraine	Vandœuvre-lès-Nancy	Grand-Est

Sponsors (1)

Lead Sponsor	Collaborator
Dr Christelle DESTINVAL

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of analgesics	number of medications taken during hospitalization	From the end of surgery to the discharge home, up to 20 days
Secondary	Length of stay	Length of stay	From the admission to the discharge home, up to 20 days
Secondary	Operating Time	Time to operate the patients	From beginning to end of surgery
Secondary	Mean Digital Pain Scale	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