AppendicitisPAMALNCT05773521
Peri-operative Analgesia for Single-incision Laparoscopic Appendectomy
An observational study of Appendicitis, run by University Hospital, Angers at 1 site in France.
Trial summary
Laparoscopic appendectomy is a very common intervention in pediatric surgery. To improve outcomes, some teams have developed the use of single-site laparoscopic appendectomy (SILAP). Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- SILAP (single incision laparoscopic appendectomy)
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2023to 31 Dec 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 1 day to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: All pediatric patients operated on by single-site access for laparoscopic appendectomy.
Who may be able to join
- All patients operated on for appendectomy by SILAP, aged 15 years and under in our pediatric surgical center.
Who cannot join
- Patients aged 16 years or more.
- Patients with concomitant pathologies potentially inducing hyper- or hypoesthesia (e.g. cancers, spinal cord injury, etc...)
- Patients with contraindications for the use of IV analgesics.
- patients operated on for appendectomy through 3-ports laparoscopy or open surgery.
- Opposition of the patients and their representative to the study.
Trial locations and contacts
1 site in 1 country.
France1 site
Angers University Hospital
Angers, 49933
Jeanne GOULIN, MD, (+33)241354290, jeanne.goulin@chu-angers.fr
Françoise SCHMITT, MD, PhD, +33241354290, FrSchmitt@chu-angers.fr
About this study
Official title: Comparative Retrospective Study on the Different Analgesic Modalities Used for Single-incision Laparoscopic Appendectomy
Laparoscopic appendectomy is a very common intervention in pediatric surgery. To improve outcomes, some teams have developed the use of single-site laparoscopic appendectomy (SILAP). Nevertheless, there is no consensus yet and no published data on the better perioperative analgesia, and different modalities including general intravenous analgesia, locoregional pre-operative analgesia and local analgesia can be used.
Read the detailed description
The aim of this retrospective study is to describe the different types of perioperative analgesia routinely used and to compare them to determine the more efficient one for early postoperative pain relief.
- Conditions
- Appendicitis
- Being tested
- SILAP (single incision laparoscopic appendectomy)
- Keywords
- appendectomy, single-site laparoscopy, analgesia, pain, peri-operative management
- Medical subject headings
- Appendicitis, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILAP (single incision laparoscopic appendectomy)Procedure or surgery
Appendectomy performed through transumbilical single access laparoscopy, consisting in the removal of the appendix.
| Study group | Role | What they receive |
|---|---|---|
| SILAP patients | This cohort is composed by all pediatric patients operated on for SILAP between January 1st, 2012 and August 31, 2022. Receives: Procedure: SILAP (single incision laparoscopic appendectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the level of pain after SILAP during the 24 first hours after surgery.
Objectified by the quantity of level 2-3 (in morphin equivalent) analgesic used up to 24 hours after surgery.
Measured: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
Secondary outcomes (5)
To assess the level of pain as measured by the different pain scales routinely used.
Objectified by the higher level of pain quoted during the first 24 hours after surgery.
Measured: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the level of pain during the initial post-operative recovery room stay.
Objectified by the higher level of pain quoted during the first 24 hours after surgery and by the amount of level 2-3 analgesic used.
Measured: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the level of pain after the 24 first hours and until hospital release.
Objectified by the higher level of pain quoted from 24 hours post-operative to hospital discharge, and by the amount of level 2-3 analgesic used.
Measured: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the different peri-operative local and loco-regional analgesia modalities used and to compare their efficiency.
Objectified by the amount of level 2-3 analgesics used in post-operative recovery room and during hospital stay.
Measured: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the types and gravity of peri-operative and post-analgesia complications.
Objectified by the description of complications encountered and classified with the Clavien and Dindo gravity scale for surgical complications.
Measured: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start31 Aug 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 AppendicitisStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Françoise Schmitt, MD, PhD, Principal investigator, University hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773521
- Sponsor's protocol ID
- 2022-124
- Acronym
- PAMAL
- Status last verified
- Aug 2023
- First submitted
- 6 Mar 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodman LF, Lin AC, Sacks MA, McRae JJLH, Radulescu A, Khan FA. Single site versus conventional laparoscopic appendectomy: some pain for no gain? J Surg Res. 2021 Aug;264:321-326. doi: 10.1016/j.jss.2021.03.010. Epub 2021 Apr 10.
PubMed 33848830Binet A, Braik K, Lengelle F, Laffon M, Lardy H, Amar S. Laparoscopic one port appendectomy: Evaluation in pediatric surgery. J Pediatr Surg. 2018 Nov;53(11):2322-2325. doi: 10.1016/j.jpedsurg.2017.12.018. Epub 2017 Dec 27.
PubMed 29370892
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Retrospective Study on the Different Analgesic Modalities Used for Single-incision Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT05773521
- Acronym / sponsor ID
- PAMAL / 2022-124
- Conditions
- Appendicitis
- Keywords
- appendectomy, single-site laparoscopy, analgesia, pain, peri-operative management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 31 Aug 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Mar 2023 (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.
Laparoscopic appendectomy is a very common intervention in pediatric surgery. To improve outcomes, some teams have developed the use of single-site laparoscopic appendectomy (SILAP). Nevertheless, there is no consensus yet and no published data on the better perioperative analgesia, and different modalities including general intravenous analgesia, locoregional pre-operative analgesia and local analgesia can be used.
Detailed description
The aim of this retrospective study is to describe the different types of perioperative analgesia routinely used and to compare them to determine the more efficient one for early postoperative pain relief.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SILAP patients | – | Procedure: SILAP (single incision laparoscopic appendectomy)This cohort is composed by all pediatric patients operated on for SILAP between January 1st, 2012 and August 31, 2022. |
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All pediatric patients operated on by single-site access for laparoscopic appendectomy.
Key inclusion criteria (1 listed)
- All patients operated on for appendectomy by SILAP, aged 15 years and under in our pediatric surgical center.
Key exclusion criteria (5 listed)
- Patients aged 16 years or more.
- Patients with concomitant pathologies potentially inducing hyper- or hypoesthesia (e.g. cancers, spinal cord injury, etc...)
- Patients with contraindications for the use of IV analgesics.
- patients operated on for appendectomy through 3-ports laparoscopy or open surgery.
- Opposition of the patients and their representative to the study.
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 |
|---|---|---|
| SILAP (single incision laparoscopic appendectomy)Appendectomy performed through transumbilical single access laparoscopy, consisting in the removal of the appendix. | Procedure or surgery | SILAP patients |
Primary outcome
To assess the level of pain after SILAP during the 24 first hours after surgery.
Time frame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
Objectified by the quantity of level 2-3 (in morphin equivalent) analgesic used up to 24 hours after surgery.
5 secondary outcomes
To assess the level of pain as measured by the different pain scales routinely used.
Time frame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the level of pain during the initial post-operative recovery room stay.
Time frame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the level of pain after the 24 first hours and until hospital release.
Time frame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the different peri-operative local and loco-regional analgesia modalities used and to compare their efficiency.
Time frame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
To assess the types and gravity of peri-operative and post-analgesia complications.
Time frame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 33848830Goodman LF, Lin AC, Sacks MA, McRae JJLH, Radulescu A, Khan FA. Single site versus conventional laparoscopic appendectomy: some pain for no gain? J Surg Res. 2021 Aug;264:321-326. doi: 10.1016/j.jss.2021.03.010. Epub 2021 Apr 10.
- Background: PubMed 29370892Binet A, Braik K, Lengelle F, Laffon M, Lardy H, Amar S. Laparoscopic one port appendectomy: Evaluation in pediatric surgery. J Pediatr Surg. 2018 Nov;53(11):2322-2325. doi: 10.1016/j.jpedsurg.2017.12.018. Epub 2017 Dec 27.
- Individual participant dataSharing planned: No
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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.
Françoise Schmitt, MD, PhD principal investigator
University hospital of Angers
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 Appendicitis, run by University Hospital, Angers 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanne Goulin, MD (+33 2 41 35 42 90, jeanne.goulin@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the level of pain after SILAP during the 24 first hours after surgery. (time frame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age). 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 NCT05773521, 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 14 Aug 2023.