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

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

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.

Study Overview

• Status: Unknown
• Conditions: Benign Uterine Diseases
• Intervention / Treatment: Procedure: laparoscopic hysterectomy

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 Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: laparoscopic hysterectomy
Other: 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	Procedure: laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
operative time	at day 1 (at the end of the surgery)

Secondary Outcome Measures

Outcome Measure	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)		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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: STORZ® laboratory
• Investigators: Principal Investigator: Revaz BOTCHORISHVILI, CHU de Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2015
• Last Update Submitted That Met QC Criteria: September 18, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: hysterectomy; Operative time; Mini-laparoscopy; Benign uterine diseases
• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: CHU-0223; 2014-A01698-39 (Other Identifier: ANSM)