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

Not Applicable

Completed

• Conditions: Appendectomy; Appendicitis
• Interventions: Procedure: Low impact laparoscopy group; Procedure: Conventional group

• Registration Number: NCT04614519
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-04
• Study Start: 2021-01-12
• Primary Completion: 2022-07-22
• Study Completion: 2022-07-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low impact laparoscopy group	Low impact laparoscopy group	Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation
Conventional group	Conventional group	Insufflation pressure at 12mmHg and conventional instrumentation

Primary Outcome Measures

Name	Time	Method
Post-operative pain decrease with low-impact laparoscopy	30 days	Decrease of 2 points on a numerical pain scale of 0 to 10 in the LIL group compared to the conventional group.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France