Cholecystitis Clinical Trial
— UltravisionOfficial title:
Reduction of Operating Time by a Smoke Electroprecipitation Device: Randomized Controlled Study on Laparoscopic Cholecystectomy for Acute Cholecystitis
The smoke produced by the electric section of the tissues during laparoscopy alters the
vision of the operative field and presents potential risks. A new medical device with CE
marking (Ultravision ©) has been developed to limit electroprecipitation on the wall and
tissues of the abdomen.
The aim of the work is to evaluate the effectiveness of this medical device in laparoscopic
cholecystectomy for cholecystitis. It is an intervention for a common pathology where smoke
is particularly important due to the tissue inflammation and due to the extensive dissection
necessary to perform the surgical procedure.
A randomized double-blinded study will be conducted in two academic hospitals (Marseille
North Hospital and Timone, APHM) evaluating the use of a smoke electroprecipitation device
(Ultravision ©) during laparoscopic cholecystectomy for cholecystitis operated at the acute
phase. A group of 30 patients using the device will be compared to a control group of 30
patients. The evaluation will last thirty days per patient and the duration of inclusion is 2
years.
The main objective is to demonstrate a significant reduction in operating duration by using
the device. The secondary objectives are to reduce the CO2 consumption, the surgical
incidents and the discomfort of the surgeon related to the smoke.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 2021 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult> 18 years old - Ability to accept consent - Acute documented cholecystitis (pain> 6h, thickening of vesicular wall on ultrasound, biological inflammatory syndrome) - Patient operated within 5 days of onset of signs - Surgery decided by laparoscopy Exclusion Criteria: Pregnant woman - Atcd umbilical abdominal surgery - Achievement of the open subcostal intervention - Patient under anticoagulant - Patient ASA3 - Age <75 years - BMI> 45 - icteric cholestasis on preoperative laboratory examination |
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Des Hopitaux de Marseille | Marseille | Paca |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | operating time | the time of the surgery calculated from the incision to the dressing (as is done routinely for each procedure on anesthesia protocols). | 2 hours |
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