Gynecologic SurgeriesMiniTrocNCT03726203
Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System
A study testing laparoscopic gynecologic surgery with the MiniLap System. and laparoscopic gynecologic surgery with the conventional single-use trocars. in people with Gynecologic Surgeries, run by University Hospital, Lille at 1 site in France.
Trial summary
During laparoscopy, trocars are essential: they allow the passage of instruments through the wall. In gynecology, with exception, trocars 5mm (used for the passage of endo-scissors and forceps) and 10 to 12mm are used (especially for optics). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gynecologic Surgeries
- What is being tested?
- laparoscopic gynecologic surgery with the MiniLap System. and laparoscopic gynecologic surgery with the conventional single-use trocars.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2019to 27 Apr 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI <35kg / m2
- No history of multiple abdominopelvic surgery
- Without absolute contraindication to laparoscopy
- In the context of ambulatory surgery
- With precise laparoscopy of indication:
- Exploratory or diagnostic
Show all 14Show fewer
- Exploration of infertility
- Performing a tubal permeability test
- Performing a salpingectomy
- Realization of a tubal sterilization
- Realization of a tubal plasty
- Performing an ovariectomy
- Performing a simple ovarian cystectomy
- Patient have been informed during her preoperative consultation and have signed the consent in a free and informed manner upon admission to hospital
Who cannot join
- Performing an emergency surgery
- Carcinological surgery
- Performing a benign but complex surgery such as:
- Hysterectomy
- Prolapse cure
- promontofixation
Show all 10Show fewer
- Complex surgery of endometriosis
- Removal of large cyst from the ovary.
- Person unable to receive informed information and / or give consent. Person deprived of liberty.
- Pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benign Gynecologic Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System in Length of Hospitalization, Pain and Aesthetics, a Randomized Study.
During laparoscopy, trocars are essential: they allow the passage of instruments through the wall. In gynecology, with exception, trocars 5mm (used for the passage of endo-scissors and forceps) and 10 to 12mm are used (especially for optics).
Trocars are responsible for complications, such as vascular wounds, digestive wounds, pain, infections or postoperative hernias, or aesthetic sequelae, and should be chosen with caution: most complications of laparoscopy are essentially due to their placement, and the complications at the introduction of the first trocar are the most frequent.
The MiniLap® system developed by Teleflex does not require trocars in the case of a single forceps, or a single 5mm trocar with the necessary forceps change (this is the Percuvance® system). The aim of the latter is to make minimally invasive surgery even less invasive, thanks to a reduction in the number of trocars used (in many cases, elimination of two trocars), smaller incisions (percutaneous use of instruments, with a diameter of 2,4mm) thus reducing the complications
- Conditions
- Gynecologic Surgeries
- Being tested
- laparoscopic gynecologic surgery with the MiniLap System., laparoscopic gynecologic surgery with the conventional single-use trocars.
- Keywords
- Laparoscopy, Trocar, MiniLap, surgery, gynecology, pain, scars, scars
- Medical subject headings
- Pain, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic gynecologic surgery with the MiniLap System.Device
Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care, but using the MiniLap System instead of the conventional single-use trocars used usually.
laparoscopic gynecologic surgery with the conventional single-use trocars.Device
Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care using the conventional single-use trocars used usually.
| Study group | Role | What they receive |
|---|---|---|
| trocars of type MiniLap | Experimental | Patients benefiting from the use of trocars of type MiniLap of Teleflex during the realization of their coelioscopy scheduled in ambulatory Receives: Device: laparoscopic gynecologic surgery with the MiniLap System. |
| trocars classics | Active comparator | Patients benefiting from the use of trocats classics during the realization of their coelioscopy scheduled(programmed) in ambulatory. Receives: Device: laparoscopic gynecologic surgery with the conventional single-use trocars. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time required to validate the Marshall and Chung criteria authorizing outpatient discharge when using the Minilap® system in comparison to the use of conventional trocars.
Measured: at the end of surgery, an average 3 hours
Secondary outcomes (5)
Pain using the Visual Analog Scale (VAS)
subjective evaluation of pain of the patient by 0 to 10 scale
Measured: at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery).
Aesthetic scars using a scale of 0 to 10
subjective evaluation of the patient and the surgeon by means of a 0 to 10 scale
Measured: postoperative visit (6 weeks ± 1 after surgery).
number of complication per operative
collection of the complications per operating by means of a questionnaire to be filled(performed) by the surgeon at the end of intervention
Measured: At immediate postoperative (baseline,1 hour and 3 hours)
of the intraoperative use of the trocar system using a questionnaire to be completed by the surgeon
Measured: At immediate postoperative (baseline,1 hour and 3 hours)
post-operative complications at the level of the trocar apertures using a questionnaire
Measured: at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start15 Jan 2019
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeriesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Teleflex
- Responsible party
- Sponsor
- Investigators
- Chrystelle Rubod, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726203
- Sponsor's protocol ID
- 2017_81
- Other IDs
- 2018-A01276-49
- Acronym
- MiniTroc
- Status last verified
- Apr 2021
- First submitted
- 29 Oct 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Gynecologic Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System in Length of Hospitalization, Pain and Aesthetics, a Randomized Study.
- ClinicalTrials.gov ID
- NCT03726203
- Acronym / sponsor ID
- MiniTroc / 2017_81
- Conditions
- Gynecologic Surgeries
- Keywords
- Laparoscopy, Trocar, MiniLap, surgery, gynecology, pain, scars, scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Teleflex
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 31 Oct 2018 (actual)
- 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.
During laparoscopy, trocars are essential: they allow the passage of instruments through the wall. In gynecology, with exception, trocars 5mm (used for the passage of endo-scissors and forceps) and 10 to 12mm are used (especially for optics).
Trocars are responsible for complications, such as vascular wounds, digestive wounds, pain, infections or postoperative hernias, or aesthetic sequelae, and should be chosen with caution: most complications of laparoscopy are essentially due to their placement, and the complications at the introduction of the first trocar are the most frequent.
The MiniLap® system developed by Teleflex does not require trocars in the case of a single forceps, or a single 5mm trocar with the necessary forceps change (this is the Percuvance® system). The aim of the latter is to make minimally invasive surgery even less invasive, thanks to a reduction in the number of trocars used (in many cases, elimination of two trocars), smaller incisions (percutaneous use of instruments, with a diameter of 2,4mm) thus reducing the complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trocars of type MiniLap | Experimental | Device: laparoscopic gynecologic surgery with the MiniLap System.Patients benefiting from the use of trocars of type MiniLap of Teleflex during the realization of their coelioscopy scheduled in ambulatory |
| trocars classics | Active comparator | Device: laparoscopic gynecologic surgery with the conventional single-use trocars.Patients benefiting from the use of trocats classics during the realization of their coelioscopy scheduled(programmed) in ambulatory. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- BMI <35kg / m2
- No history of multiple abdominopelvic surgery
- Without absolute contraindication to laparoscopy
- In the context of ambulatory surgery
- With precise laparoscopy of indication:
Key exclusion criteria (10 listed)
- Performing an emergency surgery
- Carcinological surgery
- Performing a benign but complex surgery such as:
- Person unable to receive informed information and / or give consent. Person deprived of liberty.
- Pregnant or nursing woman.
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 gynecologic surgery with the MiniLap System.Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care, but using the MiniLap System instead of the conventional single-use trocars used usually. | Device | trocars of type MiniLap |
| laparoscopic gynecologic surgery with the conventional single-use trocars.Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care using the conventional single-use trocars used usually. | Device | trocars classics |
Primary outcome
The time required to validate the Marshall and Chung criteria authorizing outpatient discharge when using the Minilap® system in comparison to the use of conventional trocars.
Time frame: at the end of surgery, an average 3 hours
5 secondary outcomes
Pain using the Visual Analog Scale (VAS)
Time frame: at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery).
Aesthetic scars using a scale of 0 to 10
Time frame: postoperative visit (6 weeks ± 1 after surgery).
number of complication per operative
Time frame: At immediate postoperative (baseline,1 hour and 3 hours)
of the intraoperative use of the trocar system using a questionnaire to be completed by the surgeon
Time frame: At immediate postoperative (baseline,1 hour and 3 hours)
post-operative complications at the level of the trocar apertures using a questionnaire
Time frame: at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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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.
Chrystelle Rubod, MD,PhD principal investigator
University Hospital, Lille
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 gynecologic surgery with the MiniLap System. and laparoscopic gynecologic surgery with the conventional single-use trocars. in people with Gynecologic Surgeries, run by University Hospital, Lille 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 14 inclusion and 10 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: finished, as of the sponsor's last update on 29 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time required to validate the Marshall and Chung criteria authorizing outpatient discharge when using the Minilap® system in comparison to the use of conventional trocars. (time frame: at the end of surgery, an average 3 hours). 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 29 Apr 2021.