Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03014817 |
| Other study ID # |
Ultrasonic scalpel trial |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
March 22, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
