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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Benign Uterine Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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standard instrument

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

Group Type EXPERIMENTAL

laparoscopic hysterectomy

Intervention Type PROCEDURE

less than 3 millimeter diameter's instruments

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

Group Type OTHER

laparoscopic hysterectomy

Intervention Type PROCEDURE

Interventions

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laparoscopic hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No