Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial
LIL-APP
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2022
CompletedMarch 24, 2026
March 1, 2026
1.5 years
October 29, 2020
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (5)
Feasibility of Low Impact Laparoscopy in appendectomies
30 days
Reduction in the average length of stay
30 days
Decrease of opioids consumption
30 days
Cost reduction in the LIL group
30 days
Faster resumption of activities
30 days
Study Arms (2)
Conventional group
ACTIVE COMPARATORInsufflation pressure at 12mmHg and conventional instrumentation
Low impact laparoscopy group
EXPERIMENTALInsufflation pressure at 7mmHg and micro-laparoscopy instrumentation
Interventions
Insufflation pressure at 12mmHg and conventional instrumentation
Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation
Eligibility Criteria
You may qualify if:
- \- Patients with acute appendicitis uncomplicated by computed tomography with injection of contrast product
You may not qualify if:
- 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
- pregnant patient
- patient incarcerated or in detention
- patient under guardianship or curatorship
- rapid sequence induction with the use of ketamine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, France
Related Publications (1)
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.
PMID: 37382370RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2020
First Posted
November 4, 2020
Study Start
January 12, 2021
Primary Completion
July 22, 2022
Study Completion
July 22, 2022
Last Updated
March 24, 2026
Record last verified: 2026-03