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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Appendicitis; Appendectomy

Treatments: Procedure: Low impact laparoscopy group; Procedure: Conventional group

Study type: Interventional

Funder types: Other

Identifiers

NCT04614519

20-AOI-02

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Conventional group

Active Comparator group

Description:

Insufflation pressure at 12mmHg and conventional instrumentation

Treatment:

Procedure: Conventional group

Low impact laparoscopy group

Experimental group

Description:

Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation

Treatment:

Procedure: Low impact laparoscopy group