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

Cholecystolithiasis Clinical Trial

— LEFFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154164
• Other study ID #: LEFFE
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Preoperatively discovered choledocholithiasis

Exclusion Criteria:

• Symptoms and signs of acute or chronic cholecystitis

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Device:
• Ultrasonic tissue coagulation dissection
ultrasonic coagulation for dissection during laparoscopic cholecystectomy

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dissection time	Time required to dissect the gallbladder from the liver	6 hours
Secondary	Level of technical complexity	Level of technical complexity of the procedure assessed by the surgeon	6 hours
Secondary	Level of technical performance	Level of technical performance during the procedure assessed by the surgeon	6 hours
Secondary	Technical performance	Intraoperative technical performance assessed by an independent observer	6 hours
Secondary	Complication rate	Intra- and postoperative complication rate	30 days