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

NCT03726203 | Completed

• 2 other identifiers: 2017_812018-A01276-49
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Gynecologic Surgeries

Keywords

Laparoscopy; Trocar; MiniLap; surgery; gynecology; pain, scars; scars

Outcome Measures

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.

  at the end of surgery, an average 3 hours

Secondary Outcomes (5)

• Pain using the Visual Analog Scale (VAS)

  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

  postoperative visit (6 weeks ± 1 after surgery).

• number of complication per operative

  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).

Study Arms (2)

trocars of type MiniLap

EXPERIMENTAL

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.

trocars classics

ACTIVE COMPARATOR

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.

Interventions

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.

trocars of type MiniLap

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.

trocars classics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Teleflex: collaborator

Study Sites (1)

Hôpital Jeanne de Flandres, CHU

Lille, France

Location

MeSH Terms

Conditions

Pain; Cicatrix

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Study Officials

• Chrystelle Rubod, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: January 15, 2019
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

FR (1)