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

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

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

Study Overview

• Status: Completed
• Conditions: Gynecologic Surgeries
• Intervention / Treatment: Device: laparoscopic gynecologic surgery with the MiniLap System.; Device: laparoscopic gynecologic surgery with the conventional single-use trocars.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Jeanne de Flandres, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Teleflex
• Investigators: Principal Investigator: Chrystelle Rubod, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): April 27, 2021
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: surgery; gynecology; Laparoscopy; scars; Trocar; MiniLap; pain, scars
• Other Study ID Numbers: 2017_81; 2018-A01276-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No