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

Benign Uterine Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02367703
• Other study ID #: CHU-0223
• Secondary ID: 2014-A01698-39
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2015
• Last updated: September 18, 2015
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Uterine Diseases
• Uterine Diseases

Intervention

Procedure:
• laparoscopic hysterectomy

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	STORZ® laboratory

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time		at day 1 (at the end of the surgery)	No
Secondary	quantity of intraoperative bleeding		at day 1 (at the end of the intervention)	No
Secondary	hemoglobin		at day 1	No
Secondary	Pain Rating Scale (VAS)		at day 1 (at 6 hours potoperative hours)	No
Secondary	Pain Rating Scale (VAS)		at day 1 (at 24 postoperative hours)	No
Secondary	standard laparoscopy conversion rate		at day 1	No
Secondary	postoperative complications	postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation	at each additional hospitalisation	No
Secondary	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.	No
Secondary	Surgen's ergonomics	Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)	at the end of the surgery	No