Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice

Study Overview
=================
Brief Summary
-----------------
Hysterectomy for benign uterine disease is often intended to young perimenopausal patients. Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if decreasing the diameter of laparoscopic instruments could reduce postoperative pain and improve esthetic result without increasing operative time. The purpose of the study is to improve patients' care.

Detailed Description
-----------------
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy. The study will be unicentric, single-blind. Study period will be one year and 4 months. Patients will be enrolled in pre-operative consultations or at the weekly staff. They will have to sign an informed consent. The day before surgery: patients will be randomized by the statistician. A resident will carry out a preoperative ultrasound to determine an estimated uterine volume. Nurses will make a blood test (hemoglobin). The day of surgery we will assess: operative time, surgeon's ergonomics, the amount of bleeding, patient's pain at rest and mobilization. At Day-1 post surgery nurses will make an other blood test (hemoglobin) and we will assess patient's pain at rest and mobilization. At the postoperative consultation we will lister : complications (Accordion Severity score classification), esthetic result (PSAQ), patient's pain.

Official Title
-----------------
Assessment of Feasibility and Benefit of the Use of Less Than 3 Millimeter Diameter's Instruments Compared to Standard Size Instruments in Laparoscopic Hysterectomy: a Randomized Single-center Comparative Study

Conditions
-----------------
Benign Uterine Diseases

Intervention / Treatment
-----------------
* Procedure: laparoscopic hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding. and affiliation to social security and informed consent Exclusion Criteria: ASA III or IV patients, age> 80 years old, history of major abdominal surgery by laparotomy severe obesity (BMI> 35kg / m2) pathology of hemostasis and coagulation (liver disease, bleeding disorders) uterine volume estimated on preoperative ultrasonography > 300 g minor patients, adult lacking legal capacity patients suffering from mental illness incompatible with informed consent, refusal to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard instrument<br>That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy | Procedure: laparoscopic hysterectomy<br> <br> |
| Other: less than 3 millimeter diameter's instruments<br>That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy | Procedure: laparoscopic hysterectomy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time |  | at day 1 (at the end of the surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantity of intraoperative bleeding |  | at day 1 (at the end of the intervention) | 
| hemoglobin |  | at day 1 | 
| Pain Rating Scale (VAS) |  | at day 1 (at 6 hours potoperative hours) | 
| Pain Rating Scale (VAS) |  | at day 1 (at 24 postoperative hours) | 
| standard laparoscopy conversion rate |  | at day 1 | 
| postoperative complications | postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation | at each additional hospitalisation | 
| Patient Scar Assessment Scale (PSAS) | Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation | at 6 and 8 weeks after surgery. | 
| Surgen's ergonomics | Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale) | at the end of the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mini-laparoscopy, hysterectomy, Benign uterine diseases, Operative time