Brief Title
Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis
Official Title
Reduction of Operating Time by a Smoke Electroprecipitation Device: Randomized Controlled Study on Laparoscopic Cholecystectomy for Acute Cholecystitis
Brief 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.
Detailed 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.
Study Type
Interventional
Primary Outcome
operating time
Condition
Cholecystitis
Intervention
medical device with CE marking (Ultravision ©)
Study Arms / Comparison Groups
EXPERIMENTAL GROUP
Description: A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch on
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
60
Start Date
September 2018
Completion Date
May 2021
Primary Completion Date
November 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
emilie garrido pradalie, +33 491372825, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03636841
Organization ID
2017-58
Responsible Party
Sponsor
Study Sponsor
Assistance Publique Hopitaux De Marseille
Study Sponsor
emilie garrido pradalie, Study Director, aphm
Verification Date
August 2018