Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System

Study Overview
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Brief Summary
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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

Official Title
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Benign Gynecologic Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System in Length of Hospitalization, Pain and Aesthetics, a Randomized Study.

Conditions
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Gynecologic Surgeries

Intervention / Treatment
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* Device: laparoscopic gynecologic surgery with the MiniLap System.
* Device: laparoscopic gynecologic surgery with the conventional single-use trocars.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: Performing an emergency surgery Carcinological surgery Performing a benign but complex surgery such as: Hysterectomy Prolapse cure promontofixation 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trocars of type MiniLap<br>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.<br>* 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.<br>|
| Active Comparator: trocars classics<br>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.<br>* Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care using the conventional single-use trocars used usually.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | at the end of surgery, an average 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain using the Visual Analog Scale (VAS) | subjective evaluation of pain of the patient by 0 to 10 scale | 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 | 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 | 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 |  | At immediate postoperative (baseline,1 hour and 3 hours) | 
| post-operative complications at the level of the trocar apertures using a questionnaire |  | at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Trocar, MiniLap, surgery, gynecology, pain, scars, scars