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

Primary Purpose

Appendicitis, Appendectomy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Conventional group
Low impact laparoscopy group
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional group

Low impact laparoscopy group

Arm Description

Insufflation pressure at 12mmHg and conventional instrumentation

Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2020
Last Updated
October 29, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04614519
Brief Title
Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial
Acronym
APP-LIL
Official Title
Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Appendectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
Insufflation pressure at 12mmHg and conventional instrumentation
Arm Title
Low impact laparoscopy group
Arm Type
Experimental
Arm Description
Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation
Intervention Type
Procedure
Intervention Name(s)
Conventional group
Intervention Description
Insufflation pressure at 12mmHg and conventional instrumentation
Intervention Type
Procedure
Intervention Name(s)
Low impact laparoscopy group
Intervention Description
Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation
Primary Outcome Measure Information:
Title
Post-operative pain decrease with low-impact laparoscopy
Description
Decrease of 2 points on a numerical pain scale of 0 to 10 in the LIL group compared to the conventional group.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Feasibility of Low Impact Laparoscopy in appendectomies
Description
Possibility of performing at least 80% of LIL procedures without conversion to conventional laparoscopy
Time Frame
30 days
Title
Reduction in the average length of stay
Description
Obtain a 10% reduction in the average length of stay between the 2 groups
Time Frame
30 days
Title
Decrease of opioids consumption
Description
Obtain a 10% reduction in the consumption of level 2 and 3 perioperative analgesics
Time Frame
30 days
Title
Cost reduction in the LIL group
Description
Equivalent operating time in the 2 groups
Time Frame
30 days
Title
Faster resumption of activities
Description
Lower costs in the LIL group compared to the conventional group
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien MASSALOU, PhD
Phone
0492033313
Ext
+33
Email
massalou.d@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hakima LABSI
Phone
0492034504
Ext
+33
Email
labsi.h@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien MASSALOU, PhD
Phone
0492033313
Ext
+33
Email
massalou.d@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Hakima LABSI
Phone
0492034504
Ext
+33
Email
labsi.h@chu-nice.fr

12. IPD Sharing Statement

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

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