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

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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