Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
Benign Uterine Diseases
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 80 years
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 32 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
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
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
laparoscopic hysterectomy PROCEDURE
Not reported in this registry record.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
operative time
Time frame: at day 1 (at the end of the surgery)
Not reported in this registry record.
Secondary measures
quantity of intraoperative bleeding
Time frame: at day 1 (at the end of the intervention)
Not reported in this registry record.
hemoglobin
Time frame: at day 1
Not reported in this registry record.
Pain Rating Scale (VAS)
Time frame: at day 1 (at 6 hours potoperative hours)
Not reported in this registry record.
Pain Rating Scale (VAS)
Time frame: at day 1 (at 24 postoperative hours)
Not reported in this registry record.
standard laparoscopy conversion rate
Time frame: at day 1
Not reported in this registry record.
postoperative complications
Time frame: at each additional hospitalisation
postoperative complications according Accordion Severity Classification score (grade\> or = 2) listed at each additional hospitalisation
Patient Scar Assessment Scale (PSAS)
Time frame: at 6 and 8 weeks after surgery.
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
Surgen's ergonomics
Time frame: at the end of the surgery
Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
CHU de Clermont-FerrandClermont-Ferrand, FranceStatus unknown
Study team and timeline
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Study start
- Apr 2, 2015 Actual
- Primary completion
- Jun 1, 2018 Actual
- Study completion
- Dec 31, 2018 Actual
- First posted
- Feb 20, 2015 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study 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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026