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

Not Applicable

• Conditions: Benign Uterine Diseases

• Registration Number: NCT02367703
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-20
• Study Start: 2015-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-09-22
• Primary Completion: 2016-06
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
operative time	at day 1 (at the end of the surgery)

Secondary Outcome Measures

Name	Time	Method
hemoglobin	at day 1
standard laparoscopy conversion rate	at day 1
quantity of intraoperative bleeding	at day 1 (at the end of the intervention)
postoperative complications	at each additional hospitalisation	postoperative complications according Accordion Severity Classification score (grade\> or = 2) listed at each additional hospitalisation
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)
Pain Rating Scale (VAS)	at day 1 (at 24 postoperative hours)

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France