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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
CHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGoperative time
Time frame: at day 1 (at the end of the surgery)
quantity of intraoperative bleeding
Time frame: at day 1 (at the end of the intervention)
hemoglobin
Time frame: at day 1
Pain Rating Scale (VAS)
Time frame: at day 1 (at 6 hours potoperative hours)
Pain Rating Scale (VAS)
Time frame: at day 1 (at 24 postoperative hours)
standard laparoscopy conversion rate
Time frame: at day 1
postoperative complications
postoperative complications according Accordion Severity Classification score (grade\> or = 2) listed at each additional hospitalisation
Time frame: at each additional hospitalisation
Patient Scar Assessment Scale (PSAS)
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
Time frame: at 6 and 8 weeks after surgery.
Surgen's ergonomics
Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
Time frame: at the end of the surgery
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