Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis
Reduction of Operating Time by a Smoke Electroprecipitation Device 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.
Context and purpose of the work:

 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.

 Material and method 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.

 Expected results 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.
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