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OpenTrials
Completed

NCT Number: NCT03726203

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

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

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Key information

Conditions

Gynecologic Surgeries Cicatrix Fibrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jeanne de Flandres, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic gynecologic surgery with the MiniLap System.

Device

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.

laparoscopic gynecologic surgery with the conventional single-use trocars.

Device

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Teleflex

Registry information

Official study title

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

Acronym: MiniTroc

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2018
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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