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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
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.
Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care using the conventional single-use trocars used usually.
Hôpital Jeanne de Flandres, CHU
Lille, France
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)
subjective evaluation of pain of the patient by 0 to 10 scale
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
subjective evaluation of the patient and the surgeon by means of a 0 to 10 scale
Time frame: 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
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).
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