Gall Stones (& [Calculus - Gall Bladder])VBASNCT06734507
Laparoscopic Cholecystectomy Using Airseal in Children
An observational study of Gall Stones (& [Calculus - Gall Bladder]) and Cholecystitis, run by Destinval Christelle at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Gall Stones (& [Calculus - Gall Bladder]), Cholecystitis, Pancreatitis Due to Gallstones
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients adressed to the University Hospital
Who may be able to join
- Patients aged under 18 years old
- Who underwent laparoscopic cholecystectomy
- From January 2021 to December 2022
Who cannot join
- Patients older than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopy Using the Airseal System Versus Standard Insufflation in Cholecystectomy in Children
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.
Read the detailed 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.
- Conditions
- Gall Stones (& [Calculus - Gall Bladder]), Cholecystitis, Pancreatitis Due to Gallstones, Child, Only
- Keywords
- Laparoscopy, Cholecystectomy, Airseal, Valveless Trocar, Standard Insufflation, Retrospective Study
- Medical subject headings
- Gallstones, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A Group | Group of patient who underwent laparoscopic cholecystectomy using Airseal | |
| S Group | Group of patient who underwent laparoscopic cholecystectomy using a standard insufflator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of analgesics consumed
Number of takings postoperatively
Measured: 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.
Measured: From the end of surgery to the discharge home, , up to 20 days
Secondary outcomes (4)
Operating time
Time-length of surgery
Measured: Perioperatively
Anesthetic time
Time-length of anesthesia
Measured: Perioperatively
Length of stay
Hospital length of stay
Measured: From the day of hospitalization to the day of discharge home, up to 20 days
Histological results
Analysis of the gall bladder after removal
Measured: Between 2 weeks and 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gall Stones (& [Calculus - Gall Bladder])Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Destinval Christelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Destinval Christelle, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734507
- Sponsor's protocol ID
- M24DC1109
- Acronym
- VBAS
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24503370de'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.
PubMed 30159821
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopy Using the Airseal System Versus Standard Insufflation in Cholecystectomy in Children
- ClinicalTrials.gov ID
- NCT06734507
- Acronym / sponsor ID
- VBAS / M24DC1109
- Conditions
- Gall Stones (& [Calculus - Gall Bladder]), Cholecystitis, Pancreatitis Due to Gallstones, Child, Only
- Keywords
- Laparoscopy, Cholecystectomy, Airseal, Valveless Trocar, Standard Insufflation, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Destinval ChristelleUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Group | – | –Group of patient who underwent laparoscopic cholecystectomy using Airseal |
| S Group | – | –Group of patient who underwent laparoscopic cholecystectomy using a standard insufflator |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients adressed to the University Hospital
Key inclusion criteria (3 listed)
- Patients aged under 18 years old
- Who underwent laparoscopic cholecystectomy
- From January 2021 to December 2022
Key exclusion criteria (1 listed)
- Patients older than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amount of analgesics consumed
Time frame: From the end of surgery to the discharge home, up to 20 days
Number of takings postoperatively
Mean Digital Pain Scale
Time frame: From the end of surgery to the 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.
4 secondary outcomes
Operating time
Time frame: Perioperatively
Anesthetic time
Time frame: Perioperatively
Length of stay
Time frame: From the day of hospitalization to the day of discharge home, up to 20 days
Histological results
Time frame: Between 2 weeks and 4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 24503370Hua 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.
- Background: PubMed 30159821de'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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gall Stones (& [Calculus - Gall Bladder]) and Cholecystitis, run by Destinval Christelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of analgesics consumed (time frame: From the end of surgery to the discharge home, up to 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734507, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.