Clinical trial NCT04165148: Low Impact Laparoscopy Concept Versus Conventional Laparoscopy
Official title: Randomized Study Comparing the Low Impact Laparoscopy Concept to Conventional Laparoscopy in Terms of Ambulatory Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ambulatory Laparoscopic Hysterectomy
Keywords: Low Impact Laparoscopy
laparoscopy
hysterectomy
ambulatory
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: success rate of ambulatory care
timeFrame: 1 month after surgery
Secondary outcomes:
measure: pain score (Visual analogic scale (VAS) for pain)
timeFrame: arrival in the post-interventional surveillance room
measure: pain score (VAS)
timeFrame: 30 minutes after exit of operating room
measure: pain score (VAS)
timeFrame: 2 hours after exit of operating room
measure: pain score (VAS)
timeFrame: 4 hours after exit of operating room
measure: pain score (VAS)
timeFrame: 6 hours after exit of operating room
measure: pain score (VAS)
timeFrame: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
measure: pain score (VAS)
timeFrame: on leaving the hospital, an average of 8 hours after surgery
measure: pain score (VAS)
timeFrame: the day after surgery
measure: pain score (VAS)
timeFrame: 1 month after surgery
measure: pain score (Saint-Antoine Pain Questionnaire (QDSA questionnaire))
timeFrame: 6 hours after exit of operating room
measure: pain score (Saint-Antoine Pain Questionnaire (QDSA))
timeFrame: the day after surgery
measure: dose of morphine
timeFrame: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
measure: number of patients who needed an analgesic
timeFrame: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
measure: number of patients who needed an analgesic
timeFrame: on leaving the hospital, an average of 8 hours after surgery
measure: number of patients who needed an analgesic
timeFrame: 1 month after surgery
measure: total administered dose
timeFrame: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
measure: total administered dose
timeFrame: on leaving the hospital, an average of 8 hours after surgery
measure: total administered dose
timeFrame: 1 month after surgery
measure: duration of analgesic treatment
timeFrame: on leaving the hospital
measure: duration of analgesic treatment
timeFrame: 1 month after surgery
measure: operating time
timeFrame: at the exit of the operating room, an average of 30 minutes after surgery
measure: number of per and postoperative complications
timeFrame: 1 month after surgery
measure: types of per and postoperative complications
timeFrame: 1 month after surgery
measure: hours total of stay in the post-intervention monitoring room
timeFrame: at the exit of a post-interventional surveillance room
measure: number of days of hospital stay
timeFrame: on leaving the hospital
measure: number of days of work stoppage
timeFrame: 1 month after surgery
measure: patient management costs
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
References: