Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
Primary Purpose
Benign Uterine Diseases
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
laparoscopic hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Benign Uterine Diseases focused on measuring Mini-laparoscopy, hysterectomy, Benign uterine diseases, Operative time
Eligibility Criteria
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.
Sites / Locations
- CHU de Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
standard instrument
less than 3 millimeter diameter's instruments
Arm 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
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
Outcomes
Primary Outcome Measures
operative time
Secondary Outcome Measures
quantity of intraoperative bleeding
hemoglobin
Pain Rating Scale (VAS)
Pain Rating Scale (VAS)
standard laparoscopy conversion rate
postoperative complications
postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation
Patient Scar Assessment Scale (PSAS)
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
Surgen's ergonomics
Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
Full Information
NCT ID
NCT02367703
First Posted
February 6, 2015
Last Updated
September 18, 2015
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
STORZ® laboratory
1. Study Identification
Unique Protocol Identification Number
NCT02367703
Brief Title
Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
STORZ® laboratory
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Uterine Diseases
Keywords
Mini-laparoscopy, hysterectomy, Benign uterine diseases, Operative time
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard instrument
Arm Type
Experimental
Arm 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
Arm Title
less than 3 millimeter diameter's instruments
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
laparoscopic hysterectomy
Primary Outcome Measure Information:
Title
operative time
Time Frame
at day 1 (at the end of the surgery)
Secondary Outcome Measure Information:
Title
quantity of intraoperative bleeding
Time Frame
at day 1 (at the end of the intervention)
Title
hemoglobin
Time Frame
at day 1
Title
Pain Rating Scale (VAS)
Time Frame
at day 1 (at 6 hours potoperative hours)
Title
Pain Rating Scale (VAS)
Time Frame
at day 1 (at 24 postoperative hours)
Title
standard laparoscopy conversion rate
Time Frame
at day 1
Title
postoperative complications
Description
postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation
Time Frame
at each additional hospitalisation
Title
Patient Scar Assessment Scale (PSAS)
Description
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
Time Frame
at 6 and 8 weeks after surgery.
Title
Surgen's ergonomics
Description
Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
Time Frame
at the end of the surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Revaz BOTCHORISHVILI
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
12. IPD Sharing Statement
Learn more about this trial
Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
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