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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-12

Study Completion Date

2022-07-22

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.

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Detailed Description

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Conditions

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Appendicitis Appendectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional group

Insufflation pressure at 12mmHg and conventional instrumentation

Group Type ACTIVE_COMPARATOR

Conventional group

Intervention Type PROCEDURE

Insufflation pressure at 12mmHg and conventional instrumentation

Low impact laparoscopy group

Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation

Group Type EXPERIMENTAL

Low impact laparoscopy group

Intervention Type PROCEDURE

Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation

Interventions

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Conventional group

Insufflation pressure at 12mmHg and conventional instrumentation

Intervention Type PROCEDURE

Low impact laparoscopy group

Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No