Low Impact Laparoscopy Concept Versus Conventional Laparoscopy

Study Overview
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Brief Summary
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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.

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

Conditions
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Ambulatory Laparoscopic Hysterectomy

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Impact Laparoscopy<br>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<br>* 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).<br>Other: Visual Analog Scale (VAS) for Pain<br>* 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.<br>Other: Saint-Antoine Pain Questionnaire (QDSA)<br>* 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.<br>Other: post-operative questionnaire<br>* 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.<br>|
| Active Comparator: conventional laparoscopy<br>conventional laparoscopy | Device: conventional laparoscopy<br>* conventional laparoscopy<br>Other: Visual Analog Scale (VAS) for Pain<br>* 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.<br>Other: Saint-Antoine Pain Questionnaire (QDSA)<br>* 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.<br>Other: post-operative questionnaire<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Impact Laparoscopy, laparoscopy, hysterectomy, ambulatory