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

NCT ID: NCT03636841

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2021-05-31

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.

Conditions

Cholecystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

EXPERIMENTAL GROUP

A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch on

Group Type: EXPERIMENTAL

medical device with CE marking (Ultravision ©)

Intervention Type: DEVICE

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.

CONTROL GROUP

A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch off

Group Type: ACTIVE_COMPARATOR

medical device with CE marking (Ultravision ©)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

emilie garrido pradalie

Role: STUDY_DIRECTOR

APHM

Locations

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, France

Countries

France

Central Contacts

thierry bege, md

Role: CONTACT

Thierry.BEGE@ap-hm.fr

+33 491372825

Facility Contacts

THIERRY BEGE, MD

Role: primary

Thierry.BEGE@ap-hm.fr

+33491372825

Other Identifiers

2017-58

Identifier Type: -

Identifier Source: org_study_id