Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System (MiniTroc)
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|ClinicalTrials.gov Identifier: NCT03726203|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : July 11, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Surgeries||Device: laparoscopic gynecologic surgery with the MiniLap System. Device: laparoscopic gynecologic surgery with the conventional single-use trocars.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: trocars of type MiniLap
Patients benefiting from the use of trocars of type MiniLap of Teleflex during the realization of their coelioscopy scheduled in ambulatory
Device: 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.
Active Comparator: trocars classics
Patients benefiting from the use of trocats classics during the realization of their coelioscopy scheduled(programmed) in ambulatory.
Device: 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.
- 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 ]
- 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). ]subjective evaluation of pain of the patient by 0 to 10 scale
- Aesthetic scars using a scale of 0 to 10 [ Time Frame: postoperative visit (6 weeks ± 1 after surgery). ]subjective evaluation of the patient and the surgeon by means of a 0 to 10 scale
- number of complication per operative [ Time Frame: At immediate postoperative (baseline,1 hour and 3 hours) ]collection of the complications per operating by means of a questionnaire to be filled(performed) by the surgeon at the end of intervention
- 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). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726203
|Contact: Chrystelle Rubod, MD,PhD||03.20.44.67.37 ext +email@example.com|
|Hôpital Jeanne de Flandres, CHU||Recruiting|
|Principal Investigator: Chrystelle Rubod, MD,PhD|
|Principal Investigator:||Chrystelle Rubod, MD,PhD||University Hospital, Lille|