Clinical trial NCT04614519: Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial
Official title: Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Appendectomy
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-operative pain decrease with low-impact laparoscopy
timeFrame: 30 days
Secondary outcomes:
measure: Feasibility of Low Impact Laparoscopy in appendectomies
timeFrame: 30 days
measure: Reduction in the average length of stay
timeFrame: 30 days
measure: Decrease of opioids consumption
timeFrame: 30 days
measure: Cost reduction in the LIL group
timeFrame: 30 days
measure: Faster resumption of activities
timeFrame: 30 days
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References: