Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial

Brief Title

Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial

Official Title

Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis. A Randomized, Double Blind, Multicenter Study

Brief Summary

      The present study aims at analyzing whether ultrasonic tissue coagulation dissection
      technique offers a smoother peri- and postoperative course and reduces the risk for
      conversion from laparoscopic to open surgery in acute cholecystectomy patients as compared to
      electrocautery in case of acute cholecystitis The study is performed as a double-blinded
      study on patients undergoing laparoscopic surgery for acute cholecystitis. Patients included
      in the study are randomized to surgery with either the traditional electrocautery based
      technique or ultrasonic scalpel based dissection.
    

Detailed Description

      Electrocautery is traditionally the method of choice for tissue dissection in laparoscopic
      cholecystectomy. As an alternative to electrocautery, the ultrasonically activated scalpel
      has proven to be an effective and safe instrument for the facilitation of dissection and to
      minimize blood loss in both open and laparoscopic surgery. Whereas electrocautery coagulates
      by burning at temperatures higher than 150ºC, the ultrasonic scalpel transforms the electric
      power into mechanical longitudinal vibration of the working part of the instrument by a
      piezoelectrical transducer. Accordingly, the former technique limits the heating- thermal
      necrosis effect on the tissue to the area just adjacent to the cutting line.

      Since the relative-potential benefit of the ultrasonic scalpel is high in technically
      demanding surgery, the advantage may not be as pronounced in routine laparoscopic gallstone
      surgery, which can usually be done more uneventfully whichever equipment is used.
      Laparoscopic cholecystectomy for acute cholecystitis is, however, more demanding connected
      with longer operative time, more postoperative complications, greater risk of conversion to
      open cholecystectomy and longer postoperative stay. In addition, we know that operations for
      acute cholecystitis are associated with a higher risk for severe complications such as bile
      duct injury. The potential benefit from using the ultrasonic scalpel is thus even greater
      when doing surgery for cholecystitis.

      In addition to this there are numerous important aspects on the safety in the implementation
      of the emergency cholecystectomy. Traditionally, most surgeons have chosen to operate these
      patients with laparoscopic technique, with the use of a so-called electrocautery hook, which
      usually allows tissue division with minimal blood loss. Further improvements in the
      dissection technique followed the introduction of ultrasonic tissue coagulation. This
      technique offers the option of performing these operations with even less blood loss, a more
      gentle handling of the inflamed tissue and a sealing of the tissue sections while the tissue
      is divided. Accordingly this ultrasonic tissue coagulation technique can theoretically be of
      significant advantage not the least when dividing acutely inflamed tissue like in acute
      cholecystitis with particular relevance for the dissection of the gallbladder from the liver
      bed, where bleeding and bile leakage often occurs. Moreover if the surgeon instead chooses to
      dissect the gallbladder from the doom and downwards, to the part that contains the cystic
      duct and cystic artery (Calots triangle), unique options can be offered to not only simplify
      the operation but also make it safer. This latter technique is called "fundus first".

      The present study aims at analyzing whether ultrasonic tissue coagulation dissection
      technique combined with "fundus first" approach offers a smoother per and postoperative
      course in acute cholecystectomy patients as compared to the traditional way of performing the
      operation. Due to the lower risk of bleeding and better anatomical overview, the technique
      may also reduce the risk of having to convert the procedure for laparoscopic cholecystectomy
      to open cholecystectomy.

      The study is performed as a double-blinded study on patients undergoing laparoscopic surgery
      for acute cholecystitis. Patients included in the study are randomized to surgery with either
      the traditional electrocautery based technique or ultrasonic scalpel based dissection with
      the "fundus first" approach.

      The choice of dissection approach is determined by the randomization procedure, whether it is
      done from the triangle of Callot + electrocautery and upwards or from the gallbladder fundus
      and downwards by the use of the ultrasonic scalpel. Peroperative cholangiography is done
      routinely. The cystic duct is closed with a clip, not with the ultrasonic scalpel.

      One month after surgery the patient is contacted by a telephone. In cases the questionnaires
      have not been returned yet, the patient is reminded about this. At the phone call the exact
      number of days of sick leave postoperatively and any adverse events occurring after discharge
      are recorded.
    

Study Type

Interventional

Primary Outcome

Postoperative complications

Secondary Outcome

 Operative time

Condition

Cholecystitis, Acute

Intervention

Ultrasonically activated scalpel

Study Arms / Comparison Groups

 Ultrasonically activated scalpel

Description:  Dissection with ultrasonically activated scalpel. Direction of dissection undecided but by experience most naturally fundus first.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

180

Start Date

October 1, 2019

Completion Date

August 2024

Primary Completion Date

August 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Emergency laparoscopic cholecystectomy performed for cholecystitis

          -  American Society of Anesthesiologists (ASA) score I-III

        Exclusion Criteria:

          -  Patients unable to express themselves in Swedish

          -  Pregnancy

          -  Previous open surgery in the upper abdomen

          -  American Society of Anesthesiologists (ASA) score >III
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Gabriel Sandblom, Assoc Prof, +46702900521, [email protected]

Location Countries

Sweden

Location Countries

Sweden

NCT ID

NCT03014817

Organization ID

Ultrasonic scalpel trial

Responsible Party

Principal Investigator

Study Sponsor

Karolinska Institutet

Study Sponsor

Gabriel Sandblom, Assoc Prof, Principal Investigator, Karolinska Institutet

Verification Date

March 2023