Clinical trial NCT03726203: Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Surgeries
Keywords: Laparoscopy
Trocar
MiniLap
surgery
gynecology
pain, scars
scars
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Teleflex
First posted: 2018-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: at the end of surgery, an average 3 hours
Secondary outcomes:
measure: Pain using the Visual Analog Scale (VAS)
timeFrame: at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery).
measure: Aesthetic scars using a scale of 0 to 10
timeFrame: postoperative visit (6 weeks ± 1 after surgery).
measure: number of complication per operative
timeFrame: At immediate postoperative (baseline,1 hour and 3 hours)
measure: of the intraoperative use of the trocar system using a questionnaire to be completed by the surgeon
timeFrame: At immediate postoperative (baseline,1 hour and 3 hours)
measure: post-operative complications at the level of the trocar apertures using a questionnaire
timeFrame: at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery).
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHU
Study officials:
affiliation: University Hospital, Lille
name: Chrystelle Rubod, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: