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

U

University Hospital, Lille

Status

Completed

Conditions

Gynecologic Surgeries

Treatments

Device: laparoscopic gynecologic surgery with the MiniLap System.
Device: laparoscopic gynecologic surgery with the conventional single-use trocars.

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03726203
2017_81
2018-A01276-49 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

trocars of type MiniLap
Experimental group
Description:
Patients benefiting from the use of trocars of type MiniLap of Teleflex during the realization of their coelioscopy scheduled in ambulatory
Treatment:
Device: laparoscopic gynecologic surgery with the MiniLap System.
trocars classics
Active Comparator group
Description:
Patients benefiting from the use of trocats classics during the realization of their coelioscopy scheduled(programmed) in ambulatory.
Treatment:
Device: laparoscopic gynecologic surgery with the conventional single-use trocars.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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