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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726203
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Teleflex
Information provided by (Responsible Party):
University Hospital, Lille

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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 15, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

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.




Primary Outcome Measures :
  1. 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. [ Time Frame: at the end of surgery, an average 3 hours ]

Secondary Outcome Measures :
  1. Pain using the Visual Analog Scale (VAS) [ Time Frame: 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

  2. Aesthetic scars using a scale of 0 to 10 [ Time Frame: postoperative visit (6 weeks ± 1 after surgery). ]
    subjective evaluation of the patient and the surgeon by means of a 0 to 10 scale

  3. number of complication per operative [ Time Frame: 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

  4. of the intraoperative use of the trocar system using a questionnaire to be completed by the surgeon [ Time Frame: At immediate postoperative (baseline,1 hour and 3 hours) ]
  5. post-operative complications at the level of the trocar apertures using a questionnaire [ Time Frame: at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery). ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726203


Contacts
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Contact: Chrystelle Rubod, MD,PhD 03.20.44.67.37 ext +33 chrystele.rubod@chru-lille.fr

Locations
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France
Hôpital Jeanne de Flandres, CHU Recruiting
Lille, France
Principal Investigator: Chrystelle Rubod, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Teleflex
Investigators
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Principal Investigator: Chrystelle Rubod, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03726203    
Other Study ID Numbers: 2017_81
2018-A01276-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Laparoscopy
Trocar
MiniLap
surgery
gynecology
pain, scars
scars