Laparoscopic Cholecystectomy Using Airseal in Children

Child, Only Clinical Trial

— VBAS  

Official title:

Low-Pressure Laparoscopy Using the Airseal System Versus Standard Insufflation in Cholecystectomy in Children: A Monocentric Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05848726
• Other study ID #: ULo
• Secondary ID: 2023PI010
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: April 13, 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 13, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Child, Only
• Cholecystitis
• Cholecystitis, Acute
• Cholecystitis, Chronic
• Gall Stones (& [Calculus - Gall Bladder])
• Gallstones
• Pancreatitis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Lorraine

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of analgesics consumed	Number of takings postoperatively	From the end of surgery to the discharge home, up to 20 days
Primary	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.	From the end of surgery to the discharge home, , up to 20 days
Secondary	Operating time	Time-length of surgery	Perioperatively
Secondary	Anesthetic time	Time-length of anesthesia	Perioperatively
Secondary	Length of stay	Hospital length of stay	From the day of hospitalization to the day of discharge home, up to 20 days
Secondary	Histological results	Analysis of the gall bladder after removal	between 2 weeks and 4 weeks after surgery