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

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)

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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.