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

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.

Study Overview

• Status: Unknown
• Conditions: Cholecystitis
• Intervention / Treatment: Device: medical device with CE marking (Ultravision ©)

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: thierry bege, md; Phone Number: +33 491372825; Email: Thierry.BEGE@ap-hm.fr

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13354
      • Assistance Publique des Hôpitaux de Marseille
      • Contact: THIERRY BEGE, MD; Phone Number: +33491372825; Email: Thierry.BEGE@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EXPERIMENTAL GROUP; A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch on	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.
ACTIVE_COMPARATOR: CONTROL GROUP; A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch off	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2018
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (ACTUAL): August 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: 2017-58

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No