Peritonitis; AcuteAPPASNCT06734494
Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis
An observational study of Peritonitis; Acute and Acute Appendicitis, run by Destinval Christelle at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Peritonitis; Acute, Acute Appendicitis, Postoperative Pain
- What is being tested?
- Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation
- Type of treatment
- Medical device
- How many people
- 100 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged between 4 and 17 years old
- Who underwent laparoscopic appendectomy for appendicular peritonitis
- Between 2022/06/1st and 2022/12/31st
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
About this study
Official title: Laparoscopic Appendectomy Using Airseal or a Standard Insufflator for Peritonitis in Children
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.
Read the detailed 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.
- Being tested
- Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation
- Keywords
- Valveless Trocar, Low-pressure Insufflation, Standard insufflation, Laparoscopic Appendectomy, Appendicular Peritonitis, Retrospective Study
- Medical subject headings
- Peritonitis, Appendicitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflationDevice
Airseal is a constant and low-pressure insufflation device. Standard insufflation is a variable pressure insufflation device.
| Study group | Role | What they receive |
|---|---|---|
| Airseal group (A) | Patients who underwent a laparoscopic appendectomy using Airseal Receives: Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation | |
| Standard group (S) | Patients who underwent a laparoscopic appendectomy using standard insufflation Receives: Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of analgesics
Number of medications taken during hospitalization
Measured: From the end of surgery to the discharge home, up to 20 days
Secondary outcomes (3)
Length of stay
Length of stay
Measured: From the admission to the discharge home, up to 20 days
Operating Time
Time to operate the patients
Measured: From beginning to end of surgery
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: Immediately after surgery until discharge home, up to 20 days
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 completion31 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 (3)Papers the sponsor has linked to this study.
- Other trials for Peritonitis; AcuteStudies 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
- 100 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
- NCT06734494
- Sponsor's protocol ID
- M24DC1108
- Acronym
- APPAS
- 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: In the name of anonymization we won't share individual participant data
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 24503370Rebuck 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.
PubMed 21457071de'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
- Laparoscopic Appendectomy Using Airseal or a Standard Insufflator for Peritonitis in Children
- ClinicalTrials.gov ID
- NCT06734494
- Acronym / sponsor ID
- APPAS / M24DC1108
- Keywords
- Valveless Trocar, Low-pressure Insufflation, Standard insufflation, Laparoscopic Appendectomy, Appendicular Peritonitis, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Destinval ChristelleUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airseal group (A) | – | Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflationPatients who underwent a laparoscopic appendectomy using Airseal |
| Standard group (S) | – | Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflationPatients who underwent a laparoscopic appendectomy using standard insufflation |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children aged between 4 and 17 years old
- Who underwent laparoscopic appendectomy for appendicular peritonitis
- Between 2022/06/1st and 2022/12/31st
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflationAirseal is a constant and low-pressure insufflation device. Standard insufflation is a variable pressure insufflation device. | Device | Airseal group (A), Standard group (S) |
Primary outcome
Consumption of analgesics
Time frame: From the end of surgery to the discharge home, up to 20 days
Number of medications taken during hospitalization
3 secondary outcomes
Length of stay
Time frame: From the admission to the discharge home, up to 20 days
Operating Time
Time frame: From beginning to end of surgery
Mean Digital Pain Scale
Time frame: Immediately after surgery until discharge home, up to 20 days
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 21457071Rebuck 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.
- 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. In the name of anonymization we won't share individual participant data
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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 Peritonitis; Acute and Acute Appendicitis, 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 3 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?
Consumption of analgesics (time frame: From the end of surgery to the discharge home, up to 20 days). 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 NCT06734494, which also lists 3 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.