Clinical Trial: Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Summary:

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 techn
Sponsor: Karolinska Institutet

Current Primary Outcome: Conversion from laparoscopic to open cholecystectomy [ Time Frame: 3 hours ]

Conversion from laparoscopic to open cholecystectomy due to technical problems during the procedure


Original Primary Outcome: Postoperative pain [ Time Frame: 6 hours ]

Postoperative pain assessed on visual analogue scale 6 hours after surgery


Current Secondary Outcome:

  • Operative time [ Time Frame: 3 hours ]
    Time required to complete surgery
  • Level of technical complexity [ Time Frame: 3 hours ]
    Level of technical complexity of the procedure as assessed by the surgeon
  • Technical performance [ Time Frame: 3 hours ]
    Perioperative technical performance assessed by an independent observer
  • Postoperative stay [ Time Frame: 14 days ]
    Time from surgery to duscharge
  • Sick leave [ Time Frame: 30 days ]
    Time from surgery to return to work
  • Postoperative complications [ Time Frame: 30 days ]
    Complications classified according to Clavien-Dindo
  • Postoperative pain [ Time Frame: 7 days ]
    Daily assessments of pain on a visual analogue scale
  • Postoperative inflammatory activity [ Time Frame: 7 days ]
    Daily measurements of c-reactive protein and leukocyte particle concentration
  • Conversion rate [ Time Frame: 3 hours ]
    Number of procedures converted to open cholecystectomy
  • Direct and indirect medical costs [ Time Frame: 30 days ]
    Analysis of health economics


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: January 5, 2017
Date Started: January 1, 2018
Date Completion: December 2022
Last Updated: March 1, 2017
Last Verified: March 2017