Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis

Cholecystitis Clinical Trial

— Ultravision  

Official title:

Reduction of Operating Time by a Smoke Electroprecipitation Device: Randomized Controlled Study on Laparoscopic Cholecystectomy for Acute Cholecystitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03636841
• Other study ID #: 2017-58
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: May 2021

Study information

• Verified date: August 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: thierry bege, md
• Phone: +33 491372825
• Email: Thierry.BEGE[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute

Intervention

Device:
• medical device with CE marking (Ultravision ©)
Ultravision © is a medical device that is used during laparoscopy to reduce the discomfort caused by surgical smoke produced by the electrical section of tissue. It works by using the principle of electrostatic precipitation, that is to say it causes the precipitation of suspended smoke droplets on the organs and walls of the abdomen.

Locations

Country	Name	City	State
France	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

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