Low Impact Laparoscopy Concept Versus Conventional Laparoscopy

  • STATUS
    Recruiting
  • End date
    May 3, 2024
  • participants needed
    85
  • sponsor
    Hospices Civils de Lyon
Updated on 29 November 2021

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.

Details
Condition Ambulatory Laparoscopic Hysterectomy
Treatment Low Impact Laparoscopy, conventional laparoscopy, Visual Analog Scale (VAS) for Pain, Saint-Antoine Pain Questionnaire (QDSA), post-operative questionnaire
Clinical Study IdentifierNCT04165148
SponsorHospices Civils de Lyon
Last Modified on29 November 2021

Eligibility

Yes No Not Sure

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
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