Low Impact Laparoscopy Concept Versus Conventional Laparoscopy (RANDOLIL)

Civil Hospices of Lyon

Status: Terminated

Conditions: Ambulatory Laparoscopic Hysterectomy

Treatments: Other: post-operative questionnaire; Other: Saint-Antoine Pain Questionnaire (QDSA); Device: Low Impact Laparoscopy; Device: conventional laparoscopy; Other: Visual Analog Scale (VAS) for Pain

Study type: Interventional

Funder types: Other

Identifiers

NCT04165148

69HCL19_0335

2019-A01863-54 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Low Impact Laparoscopy

Experimental group

Description:

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).

Treatment:

Other: post-operative questionnaire

Other: Visual Analog Scale (VAS) for Pain

Device: Low Impact Laparoscopy

Other: Saint-Antoine Pain Questionnaire (QDSA)

conventional laparoscopy

Active Comparator group

Description:

conventional laparoscopy

Treatment:

Other: post-operative questionnaire

Other: Visual Analog Scale (VAS) for Pain

Other: Saint-Antoine Pain Questionnaire (QDSA)

Device: conventional laparoscopy