Clinical trial NCT02367703: Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Uterine Diseases
Keywords: Mini-laparoscopy
hysterectomy
Benign uterine diseases
Operative time
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: STORZ® laboratory
First posted: 2015-02-20
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: operative time
timeFrame: at day 1 (at the end of the surgery)
Secondary outcomes:
measure: quantity of intraoperative bleeding
timeFrame: at day 1 (at the end of the intervention)
measure: hemoglobin
timeFrame: at day 1
measure: Pain Rating Scale (VAS)
timeFrame: at day 1 (at 6 hours potoperative hours)
measure: Pain Rating Scale (VAS)
timeFrame: at day 1 (at 24 postoperative hours)
measure: standard laparoscopy conversion rate
timeFrame: at day 1
measure: postoperative complications
timeFrame: at each additional hospitalisation
measure: Patient Scar Assessment Scale (PSAS)
timeFrame: at 6 and 8 weeks after surgery.
measure: Surgen's ergonomics
timeFrame: at the end of the surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Revaz BOTCHORISHVILI
role: PRINCIPAL_INVESTIGATOR
References: