Benign Uterine Diseases
Conditions
Keywords
Mini-laparoscopy, hysterectomy, Benign uterine diseases, Operative time
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.
Interventions
PROCEDURElaparoscopic hysterectomy
Sponsors
STORZ® laboratory
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| operative time | at day 1 (at the end of the surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hemoglobin | at day 1 | — |
| Pain Rating Scale (VAS) | at day 1 (at 6 hours potoperative hours) | — |
| standard laparoscopy conversion rate | at day 1 | — |
| quantity of intraoperative bleeding | at day 1 (at the end of the intervention) | — |
| Patient Scar Assessment Scale (PSAS) | at 6 and 8 weeks after surgery. | Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation |
| Surgen's ergonomics | at the end of the surgery | Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale) |
| postoperative complications | at each additional hospitalisation | postoperative complications according Accordion Severity Classification score (grade\> or = 2) listed at each additional hospitalisation |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Outcome results
None listed