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

Not Applicable

Completed

• Conditions: Gynecologic Surgeries
• Interventions: Device: laparoscopic gynecologic surgery with the MiniLap System.; Device: laparoscopic gynecologic surgery with the conventional single-use trocars.

• Registration Number: NCT03726203
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Study Start: 2019-01-15
• Status Verified: 2021-04
• Primary Completion: 2021-04-27
• Study Completion: 2021-04-27
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trocars of type MiniLap	laparoscopic gynecologic surgery with the MiniLap System.	Patients benefiting from the use of trocars of type MiniLap of Teleflex during the realization of their coelioscopy scheduled in ambulatory
trocars classics	laparoscopic gynecologic surgery with the conventional single-use trocars.	Patients benefiting from the use of trocats classics during the realization of their coelioscopy scheduled(programmed) in ambulatory.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Pain using the Visual Analog Scale (VAS)	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
Aesthetic scars using a scale of 0 to 10	postoperative visit (6 weeks ± 1 after surgery).	subjective evaluation of the patient and the surgeon by means of a 0 to 10 scale
number of complication per operative	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
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).

Trial Locations

Locations (1)

Hôpital Jeanne de Flandres, CHU; 🇫🇷 Lille, France