Low Impact Laparoscopy Concept Versus Conventional Laparoscopy (RANDOLIL)

Randomized Study Comparing the Low Impact Laparoscopy Concept to Conventional Laparoscopy in Terms of Ambulatory Care

Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS.

The feasibility and safety of laparoscopy is well established, particularly in the field of gynecology, but this technique often causes postoperative pain. Techniques are being developed to reduce postoperative pain in laparoscopic surgery. Low pressure insufflation (7 to 10 mmHg) compared to standard pressure insufflation (12 to 15 mmHg) significantly reduces postoperative pain. Microcoelioscopy (use of 3 mm trocars instead of 5 to 12 mm trocars in standard laparoscopy), by reducing the size of incisions, also significantly reduces postoperative pain.

The Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation and microcoelioscopy which would have the advantage of reducing postoperative pain. This technique would therefore, by reducing postoperative pain, to improve outpatient management, particularly in cases of hysterectomies for which the outpatient management rate could be increased.

The hypothesis is that using the Low Impact Laparoscopy concept would increase outpatient management rate compared to conventional laparoscopy in gynecological surgeries for hysterectomy.

The study aims to compare the Low Impact Laparoscopy concept with conventional laparoscopy in terms of ambulatory care rates in patients undergoing surgery for hysterectomy.

Study Overview

• Status: Terminated
• Conditions: Ambulatory Laparoscopic Hysterectomy
• Intervention / Treatment: Device: Low Impact Laparoscopy; Other: Visual Analog Scale (VAS) for Pain; Other: Saint-Antoine Pain Questionnaire (QDSA); Other: post-operative questionnaire; Device: conventional laparoscopy

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Géry LAMBLIN, PU,PH; Phone Number: +33 04 72 35 58 71; Email: gery.lamblin@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69677
    • Hôpital Femme Mère Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• women over 18 years
• planned surgery procedure : ambulatory laparoscopic hysterectomy
• effective contraception if women of childbearing age
• patients with free, informed and signed consent

Exclusion Criteria:

• disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
• pregnancy or wish for subsequent pregnancy
• lactating women
• contraindication to laparoscopy
• contraindication to minimally invasive endoscopic techniques
• not eligible for outpatient care
• inability to understand the information given
• a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Impact Laparoscopy; Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the Intelligent Flow System (iFS) AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).	Device: Low Impact Laparoscopy; Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the iFS AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).; Other: Visual Analog Scale (VAS) for Pain; The patient evaluates her pain using an VAS scale on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital. The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with VAS scale) will be collected. During the usual consultation at 1 month, the patient must evaluate her pain by means of an VAS.; Other: Saint-Antoine Pain Questionnaire (QDSA); The patient evaluates her pain using an QDSA questionnaire on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital. The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with QDSA questionnaire) will be collected. During the usual consultation at 1 month, the patient must evaluate her pain by means of an QDSA questionnaire.; Other: post-operative questionnaire; The patient will fill in the antalgic intake record and the patient booklet for the collection of medical consumptions from her discharge from the hospital and during the month following the surgery.
Active Comparator: conventional laparoscopy	Other: Visual Analog Scale (VAS) for Pain; The patient evaluates her pain using an VAS scale on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital. The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with VAS scale) will be collected. During the usual consultation at 1 month, the patient must evaluate her pain by means of an VAS.; Other: Saint-Antoine Pain Questionnaire (QDSA); The patient evaluates her pain using an QDSA questionnaire on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital. The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with QDSA questionnaire) will be collected. During the usual consultation at 1 month, the patient must evaluate her pain by means of an QDSA questionnaire.; Other: post-operative questionnaire; The patient will fill in the antalgic intake record and the patient booklet for the collection of medical consumptions from her discharge from the hospital and during the month following the surgery.; Device: conventional laparoscopy; conventional laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of ambulatory care	rate of patients actually managed on an outpatient setting (discharged from hospital the same day of the intervention) and who presented no complication or rehospitalization in the month following the intervention	1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score (Visual analogic scale (VAS) for pain)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	arrival in the post-interventional surveillance room
pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	30 minutes after exit of operating room
pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	2 hours after exit of operating room
pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	4 hours after exit of operating room
pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	6 hours after exit of operating room
pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	on leaving the hospital, an average of 8 hours after surgery
pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	the day after surgery
pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)	1 month after surgery
pain score (Saint-Antoine Pain Questionnaire (QDSA questionnaire))	Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64.	6 hours after exit of operating room
pain score (Saint-Antoine Pain Questionnaire (QDSA))	Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64	the day after surgery
dose of morphine	total dose of morphine (miligramme (mg)) administered in the post-interventional surveillance room	at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
number of patients who needed an analgesic	number of patients who needed an analgesic supplement in post-interventional monitoring room	at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
number of patients who needed an analgesic	number of patients who needed an analgesic supplement in post-interventional monitoring room	on leaving the hospital, an average of 8 hours after surgery
number of patients who needed an analgesic	number of patients who needed an analgesic supplement in post-interventional monitoring room	1 month after surgery
total administered dose	total administered dose of analgesic supplement (mg) in post-interventional monitoring room	at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
total administered dose	total administered dose of analgesic supplement (mg) in post-interventional monitoring room	on leaving the hospital, an average of 8 hours after surgery
total administered dose	total administered dose of analgesic supplement (mg) in post-interventional monitoring room	1 month after surgery
duration of analgesic treatment	duration of analgesic treatment (days) during the hospital stay	on leaving the hospital
duration of analgesic treatment	duration of analgesic treatment (days) during the hospital stay	1 month after surgery
operating time	operative time (between incision and closure) in minutes	at the exit of the operating room, an average of 30 minutes after surgery
number of per and postoperative complications	number of per and postoperative complications	1 month after surgery
types of per and postoperative complications	description of per and postoperative complications	1 month after surgery
hours total of stay in the post-intervention monitoring room	length of stay in the post-interventional surveillance room in hours	at the exit of a post-interventional surveillance room
number of days of hospital stay	length of hospital stay (if non ambulatory care) in number of days	on leaving the hospital
number of days of work stoppage	duration of work stoppage of the patient in number of days	1 month after surgery
patient management costs	Patient management costs according to the two surgical strategies	1 month after surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): September 3, 2023

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopy; hysterectomy; ambulatory; Low Impact Laparoscopy
• Other Study ID Numbers: 69HCL19_0335; 2019-A01863-54 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No