Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial

Appendicitis Clinical Trial

— LIL-APP  

Official title:

Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614519
• Other study ID #: 20-AOI-02
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: July 22, 2022

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 22, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendectomy
• Appendicitis

Intervention

Procedure:
• Conventional group
Insufflation pressure at 12mmHg and conventional instrumentation
• Low impact laparoscopy group
Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

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