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

NCT ID: NCT03726203

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-04-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

laparoscopic gynecologic surgery with the MiniLap System.

Intervention Type: 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 classics

Patients benefiting from the use of trocats classics during the realization of their coelioscopy scheduled(programmed) in ambulatory.

Group Type: ACTIVE_COMPARATOR

laparoscopic gynecologic surgery with the conventional single-use trocars.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teleflex

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chrystelle Rubod, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Jeanne de Flandres, CHU

Lille, , France

Countries

France

Other Identifiers

2018-A01276-49

Identifier Type: OTHER

Identifier Source: secondary_id

2017_81

Identifier Type: -

Identifier Source: org_study_id