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

Study Overview
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Brief Summary
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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.

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

Conditions
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Appendicitis, Appendectomy

Intervention / Treatment
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* Procedure: Conventional group
* Procedure: Low impact laparoscopy group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |