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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01698-39 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| STORZ® laboratory | UNKNOWN |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard instrument | Experimental | 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 |
|
| less than 3 millimeter diameter's instruments | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic hysterectomy | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| operative time | at day 1 (at the end of the surgery) |
| 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) |
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Inclusion Criteria:
and
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Revaz BOTCHORISHVILI | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| 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 |