Study on the Learning Curve for Fundus First With Ultrasonic Tissue Coagulation in Elective Cholecystectomy

Study Overview
=================
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.

Official Title
-----------------
Study on the Learning Curve for Fundus First With Ultrasonic Tissue Coagulation in Elective Cholecystectomy

Conditions
-----------------
Cholecystolithiasis

Intervention / Treatment
-----------------
* Device: Ultrasonic tissue coagulation dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preoperatively discovered choledocholithiasis Exclusion Criteria: Symptoms and signs of acute or chronic cholecystitis

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasonic tissue coagulation dissection|ultrasonic coagulation for dissection during laparoscopic cholecystectomy|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dissection time | Time required to dissect the gallbladder from the liver | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of technical complexity | Level of technical complexity of the procedure assessed by the surgeon | 6 hours | 
| Level of technical performance | Level of technical performance during the procedure assessed by the surgeon | 6 hours | 
| Technical performance | Intraoperative technical performance assessed by an independent observer | 6 hours | 
| Complication rate | Intra- and postoperative complication rate | 30 days |