AppendicitisLIL-APPNCT04614519
Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial
A study testing Conventional group and Low impact laparoscopy group in people with Appendicitis and Appendectomy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Introduction: Surgery performed under low insufflation pressure combined with micro-laparoscopy (incisions 4X smaller than incisions in conventional laparoscopy) is called "low impact laparoscopy" or LIL. It significantly reduces postoperative pain and reduces the average length of stay. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Appendicitis, Appendectomy
- What is being tested?
- Conventional group and Low impact laparoscopy group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2021to 22 Jul 2022
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute appendicitis uncomplicated by computed tomography with injection of contrast product
Who cannot join
- coagulopathy or thrombopathy
- arguments for a complicated appendicitis: fever> 38.5 ° C, hyperleucytosis> 15,000, CRP> 100, presence of an intraperitoneal abscess, a plastron, a fluid effusion of medium or great abundance or '' a pneumoperitoneum on the CT scan
- History of abdominal surgery by laparotomy
- Obese patients (BMI> 30kg / m2)
- minor patients
- patients without health insurance
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- pregnant patient
- patient incarcerated or in detention
- patient under guardianship or curatorship
- rapid sequence induction with the use of ketamine
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Surgery performed under low insufflation pressure combined with micro-laparoscopy (incisions 4X smaller than incisions in conventional laparoscopy) is called "low impact laparoscopy" or LIL. It significantly reduces postoperative pain and reduces the average length of stay.
This technique, currently underdeveloped has never been evaluated in the literature for appendectomy.
Read more
Main objective of the study: to obtain a reduction in postoperative pain when using the low-impact laparoscopy technique for appendectomies.
Secondary objectives: to study the feasibility of LIL in appendectomies, to obtain a reduction in the average length of stay, a reduction in the consumption of analgesics, a reduction in costs, and a more rapid resumption of activities.
Material and methods :
This is a prospective, single-center, double-blind study. The inclusion criterion is the presence of acute uncomplicated appendicitis. The number of subjects to be included in each group is evaluated at 25. The subjects are divided into two groups preoperatively:
- Conventional group: insufflation pressure at 12mmHg and conventional instrumentation
- LIL group: insufflation pressure at 7mmHg and micro-laparoscopy instrumentation.
Identical dressings are put in place at the end of the procedure in order to hide from the patient the protocol in which he was included.
Pain assessment is recorded daily during the first postoperative week. The consumption of analgesics is also recorded. Then on the 7th day, 15th day and 30th postoperative day. During hospitalization, readings are taken by the nurse. At home, the data is entered by the patient via the Link4Life smartphone application.
Conclusion: LIL applied to appendectomy has never been evaluated in the literature. It would allow a reduction in postoperative pain, the average length of stay for patients as well as improved rehabilitation.
- Conditions
- Appendicitis, Appendectomy
- Being tested
- Conventional group, Low impact laparoscopy group
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional groupProcedure or surgery
Insufflation pressure at 12mmHg and conventional instrumentation
Low impact laparoscopy groupProcedure or surgery
Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | Insufflation pressure at 12mmHg and conventional instrumentation Receives: Procedure: Conventional group |
| Low impact laparoscopy group | Experimental | Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation Receives: Procedure: Low impact laparoscopy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain decrease with low-impact laparoscopy
Decrease of 2 points on a numerical pain scale of 0 to 10 in the LIL group compared to the conventional group.
Measured: 30 days
Secondary outcomes (5)
Feasibility of Low Impact Laparoscopy in appendectomies
Possibility of performing at least 80% of LIL procedures without conversion to conventional laparoscopy
Measured: 30 days
Reduction in the average length of stay
Obtain a 10% reduction in the average length of stay between the 2 groups
Measured: 30 days
Decrease of opioids consumption
Obtain a 10% reduction in the consumption of level 2 and 3 perioperative analgesics
Measured: 30 days
Cost reduction in the LIL group
Equivalent operating time in the 2 groups
Measured: 30 days
Faster resumption of activities
Lower costs in the LIL group compared to the conventional group
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start12 Jan 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614519
- Sponsor's protocol ID
- 20-AOI-02
- Acronym
- LIL-APP
- Status last verified
- Mar 2026
- First submitted
- 29 Oct 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Etienne JH, Salucki B, Gridel V, Orban JC, Baque P, Massalou D. Low-Impact Laparoscopy vs Conventional Laparoscopy for Appendectomy: A Prospective Randomized Trial. J Am Coll Surg. 2023 Oct 1;237(4):622-631. doi: 10.1097/XCS.0000000000000795. Epub 2023 Jun 29.
PubMed 37382370
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial
- ClinicalTrials.gov ID
- NCT04614519
- Acronym / sponsor ID
- LIL-APP / 20-AOI-02
- Conditions
- Appendicitis, Appendectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 4 Nov 2020 (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.
Introduction: Surgery performed under low insufflation pressure combined with micro-laparoscopy (incisions 4X smaller than incisions in conventional laparoscopy) is called "low impact laparoscopy" or LIL. It significantly reduces postoperative pain and reduces the average length of stay.
This technique, currently underdeveloped has never been evaluated in the literature for appendectomy.
Main objective of the study: to obtain a reduction in postoperative pain when using the low-impact laparoscopy technique for appendectomies.
Secondary objectives: to study the feasibility of LIL in appendectomies, to obtain a reduction in the average length of stay, a reduction in the consumption of analgesics, a reduction in costs, and a more rapid resumption of activities.
Material and methods :
This is a prospective, single-center, double-blind study. The inclusion criterion is the presence of acute uncomplicated appendicitis. The number of subjects to be included in each group is evaluated at 25. The subjects are divided into two groups preoperatively:
- Conventional group: insufflation pressure at 12mmHg and conventional instrumentation
- LIL group: insufflation pressure at 7mmHg and micro-laparoscopy instrumentation.
Identical dressings are put in place at the end of the procedure in order to hide from the patient the protocol in which he was included.
Pain assessment is recorded daily during the first postoperative week. The consumption of analgesics is also recorded. Then on the 7th day, 15th day and 30th postoperative day. During hospitalization, readings are taken by the nurse. At home, the data is entered by the patient via the Link4Life smartphone application.
Conclusion: LIL applied to appendectomy has never been evaluated in the literature. It would allow a reduction in postoperative pain, the average length of stay for patients as well as improved rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Procedure: Conventional groupInsufflation pressure at 12mmHg and conventional instrumentation |
| Low impact laparoscopy group | Experimental | Procedure: Low impact laparoscopy groupInsufflation pressure at 7mmHg and micro-laparoscopy instrumentation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute appendicitis uncomplicated by computed tomography with injection of contrast product
Key exclusion criteria (10 listed)
- coagulopathy or thrombopathy
- arguments for a complicated appendicitis: fever> 38.5 ° C, hyperleucytosis> 15,000, CRP> 100, presence of an intraperitoneal abscess, a plastron, a fluid effusion of medium or great abundance or '' a pneumoperitoneum on the CT scan
- History of abdominal surgery by laparotomy
- Obese patients (BMI> 30kg / m2)
- minor patients
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 |
|---|---|---|
| Conventional groupInsufflation pressure at 12mmHg and conventional instrumentation | Procedure or surgery | Conventional group |
| Low impact laparoscopy groupInsufflation pressure at 7mmHg and micro-laparoscopy instrumentation | Procedure or surgery | Low impact laparoscopy group |
Primary outcome
Post-operative pain decrease with low-impact laparoscopy
Time frame: 30 days
Decrease of 2 points on a numerical pain scale of 0 to 10 in the LIL group compared to the conventional group.
5 secondary outcomes
Feasibility of Low Impact Laparoscopy in appendectomies
Time frame: 30 days
Reduction in the average length of stay
Time frame: 30 days
Decrease of opioids consumption
Time frame: 30 days
Cost reduction in the LIL group
Time frame: 30 days
Faster resumption of activities
Time frame: 30 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 24 Mar 2026.
- Results publication: PubMed 37382370Etienne JH, Salucki B, Gridel V, Orban JC, Baque P, Massalou D. Low-Impact Laparoscopy vs Conventional Laparoscopy for Appendectomy: A Prospective Randomized Trial. J Am Coll Surg. 2023 Oct 1;237(4):622-631. doi: 10.1097/XCS.0000000000000795. Epub 2023 Jun 29.
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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?
A study testing Conventional group and Low impact laparoscopy group in people with Appendicitis and Appendectomy, run by Centre Hospitalier Universitaire de Nice 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 10 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 24 Mar 2026. 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?
Post-operative pain decrease with low-impact laparoscopy (time frame: 30 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 NCT04614519, which also lists 1 linked publication.
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 24 Mar 2026.