Low Impact Laparoscopy Concept Versus Conventional Laparoscopy

Summary

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.

Conditions

• Ambulatory Laparoscopic Hysterectomy

Interventions

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).

DEVICE

conventional laparoscopy

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.

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-03

Primary Completion

2023-01-03

Completion

2023-09-03

Countries

• France

Study Locations