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

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT03726203

Collaborator

Teleflex (Industry)

Enrollment

Location

Arms

27.4

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

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.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 :

Jan 15, 2019

Actual Primary Completion Date :

Apr 27, 2021

Actual Study Completion Date :

Apr 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Pain using the Visual Analog Scale (VAS) [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 [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 [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 [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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.