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

NCT03726203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-04-29

No results posted yet for this study

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

Conditions

  • Gynecologic Surgeries

Interventions

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.

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.

Sponsors & Collaborators

  • Teleflex

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Chrystelle Rubod, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2021-04-27
Completion
2021-04-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03726203 on ClinicalTrials.gov