Benign Uterine DiseasesNCT02367703
Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
A study testing laparoscopic hysterectomy in people with Benign Uterine Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Benign Uterine Diseases
- What is being tested?
- laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- minor patients,
- adult lacking legal capacity
- patients suffering from mental illness incompatible with informed consent, refusal to participate.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
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
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 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.
- Conditions
- Benign Uterine Diseases
- Being tested
- laparoscopic hysterectomy
- Keywords
- Mini-laparoscopy, hysterectomy, Benign uterine diseases, Operative time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic hysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| standard instrument | Experimental | 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 Receives: Procedure: laparoscopic hysterectomy |
| less than 3 millimeter diameter's instruments | Other | 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 Receives: Procedure: laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Measured: at day 1 (at the end of the surgery)
Secondary outcomes (8)
quantity of intraoperative bleeding
Measured: at day 1 (at the end of the intervention)
hemoglobin
Measured: at day 1
Pain Rating Scale (VAS)
Measured: at day 1 (at 6 hours potoperative hours)
Pain Rating Scale (VAS)
Measured: at day 1 (at 24 postoperative hours)
standard laparoscopy conversion rate
Measured: at day 1
postoperative complications
postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation
Measured: at each additional hospitalisation
Patient Scar Assessment Scale (PSAS)
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
Measured: at 6 and 8 weeks after surgery.
Surgen's ergonomics
Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
Measured: at the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Uterine DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- STORZ® laboratory
- Responsible party
- Sponsor
- Investigators
- Revaz BOTCHORISHVILI, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367703
- Sponsor's protocol ID
- CHU-0223
- Other IDs
- 2014-A01698-39
- Status last verified
- Sep 2015
- First submitted
- 6 Feb 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02367703
- Acronym / sponsor ID
- CHU-0223
- Conditions
- Benign Uterine Diseases
- Keywords
- Mini-laparoscopy, hysterectomy, Benign uterine diseases, Operative time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- STORZ® laboratory
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard instrument | Experimental | Procedure: laparoscopic hysterectomyThat 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 |
| less than 3 millimeter diameter's instruments | Other | Procedure: laparoscopic hysterectomyThat 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic hysterectomy | Procedure or surgery | less than 3 millimeter diameter's instruments, standard instrument |
Primary outcome
operative time
Time frame: at day 1 (at the end of the surgery)
8 secondary outcomes
quantity of intraoperative bleeding
Time frame: at day 1 (at the end of the intervention)
hemoglobin
Time frame: at day 1
Pain Rating Scale (VAS)
Time frame: at day 1 (at 6 hours potoperative hours)
Pain Rating Scale (VAS)
Time frame: at day 1 (at 24 postoperative hours)
standard laparoscopy conversion rate
Time frame: at day 1
postoperative complications
Time frame: at each additional hospitalisation
Patient Scar Assessment Scale (PSAS)
Time frame: at 6 and 8 weeks after surgery.
Surgen's ergonomics
Time frame: at the end of the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Revaz BOTCHORISHVILI principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic hysterectomy in people with Benign Uterine Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: at day 1 (at the end of the surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.