NCT03154164

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: —

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.

Conditions

• Cholecystolithiasis

Interventions

Type	Name	Description
DEVICE	Ultrasonic tissue coagulation dissection	ultrasonic coagulation for dissection during laparoscopic cholecystectomy

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-05-16
• Last updated: 2021-05-17

Locations

1 site across 1 country: Sweden