Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Benign Uterine Diseases

Treatments: Procedure: laparoscopic hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02367703

2014-A01698-39 (Other Identifier)

CHU-0223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

standard instrument

Experimental group

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

Treatment:

Procedure: laparoscopic hysterectomy

less than 3 millimeter diameter's instruments

Other group

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

Treatment:

Procedure: laparoscopic hysterectomy