Laparoscopic Cholecystectomy Using Airseal in Children

NCT06734507 | Completed

• 1 other identifier: M24DC1109
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gall Stones (& [Calculus - Gall Bladder]); Cholecystitis; Pancreatitis Due to Gallstones; Child, Only

Keywords

Laparoscopy; Cholecystectomy; Airseal; Valveless Trocar; Standard Insufflation; Retrospective Study

Outcome Measures

Primary Outcomes (2)

• Amount of analgesics consumed

  Number of takings postoperatively

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

• 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 Outcomes (4)

• Operating time

  Perioperatively

• Anesthetic time

  Perioperatively

• Length of stay

  From the day of hospitalization to the day of discharge home, up to 20 days

• Histological results

  Between 2 weeks and 4 weeks after surgery

Study Arms (2)

A Group

Group of patient who underwent laparoscopic cholecystectomy using Airseal

S Group

Group of patient who underwent laparoscopic cholecystectomy using a standard insufflator

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients adressed to the University Hospital

You may qualify if:

• Patients aged under 18 years old
• Who underwent laparoscopic cholecystectomy
• From January 2021 to December 2022

You may not qualify if:

• Patients older than 18 years old

Sponsors & Collaborators

• Destinval Christelle: lead

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Location

Related Publications (2)

• 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

• 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

Gallstones; Cholecystitis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, 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 1, 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)