Gynecologic Surgeries Clinical Trial
— MiniTrocOfficial title:
Benign Gynecologic Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System in Length of Hospitalization, Pain and Aesthetics, a Randomized Study.
| Verified date | April 2021 |
| Source | University Hospital, Lille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | April 27, 2021 |
| Est. primary completion date | April 27, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Jeanne de Flandres, CHU | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille | Teleflex |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Pain using the Visual Analog Scale (VAS) | subjective evaluation of pain of the patient by 0 to 10 scale | at immediate postoperative (baseline,1 hour and 3 hours) and postoperative visit (6 weeks ± 1 after surgery). | |
| Secondary | Aesthetic scars using a scale of 0 to 10 | subjective evaluation of the patient and the surgeon by means of a 0 to 10 scale | postoperative visit (6 weeks ± 1 after surgery). | |
| Secondary | number of complication per operative | collection of the complications per operating by means of a questionnaire to be filled(performed) by the surgeon at the end of intervention | At immediate postoperative (baseline,1 hour and 3 hours) | |
| Secondary | 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) | ||
| Secondary | 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). |