Benign Uterine Diseases Clinical Trial
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment