Cholecystolithiasis
Conditions
Brief summary
The present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. Patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All participating surgeons have experience of the traditional approach with electrocautery. The operation time as well as the surgeons own evaluation of difficulty and performance are noted. Selected films are analyzed by independent surgeons with experience of the fundus first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to record the intra and postoperative complication rate.
Detailed description
The present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. Patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All participating surgeons have experience of the traditional approach with electrocautery, but limited experience from gallstone surgery with ultrasonic tissue coagulation dissection. The operation time as well as the surgeons own evaluation of difficulty and performance are noted. Selected video recordings are analyzed by independent surgeons with experience of the fundus first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to record the intra and postoperative complication rate. The study is intended to serve as a pilot study for a subsequent randomised controlled trial, comparing surgery with electrocautery and ultrasonic tissue coagulation dissection.
Interventions
DEVICEUltrasonic tissue coagulation dissection
ultrasonic coagulation for dissection during laparoscopic cholecystectomy
Sponsors
Karolinska Institutet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Inclusion criteria
* Preoperatively discovered choledocholithiasis
Exclusion criteria
* Symptoms and signs of acute or chronic cholecystitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dissection time | 6 hours | Time required to dissect the gallbladder from the liver |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of technical complexity | 6 hours | Level of technical complexity of the procedure assessed by the surgeon |
| Level of technical performance | 6 hours | Level of technical performance during the procedure assessed by the surgeon |
| Technical performance | 6 hours | Intraoperative technical performance assessed by an independent observer |
| Complication rate | 30 days | Intra- and postoperative complication rate |
Countries
Sweden
Outcome results
None listed