Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial (LIL-APP)

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 Overview

• Status: Completed
• Conditions: Appendicitis; Appendectomy
• Intervention / Treatment: Procedure: Conventional group; Procedure: Low impact laparoscopy group

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Chu de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patients with acute appendicitis uncomplicated by computed tomography with injection of contrast product

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional group; Insufflation pressure at 12mmHg and conventional instrumentation	Procedure: Conventional group; Insufflation pressure at 12mmHg and conventional instrumentation
Experimental: Low impact laparoscopy group; Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation	Procedure: Low impact laparoscopy group; Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Low Impact Laparoscopy in appendectomies	Possibility of performing at least 80% of LIL procedures without conversion to conventional laparoscopy	30 days
Reduction in the average length of stay	Obtain a 10% reduction in the average length of stay between the 2 groups	30 days
Decrease of opioids consumption	Obtain a 10% reduction in the consumption of level 2 and 3 perioperative analgesics	30 days
Cost reduction in the LIL group	Equivalent operating time in the 2 groups	30 days
Faster resumption of activities	Lower costs in the LIL group compared to the conventional group	30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: 20-AOI-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No