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

NCT ID: NCT03154164

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-12-31

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.

Conditions

Cholecystolithiasis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasonic tissue coagulation dissection

ultrasonic coagulation for dissection during laparoscopic cholecystectomy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Preoperatively discovered choledocholithiasis

Exclusion Criteria

• Symptoms and signs of acute or chronic cholecystitis

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Sandblom

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

LEFFE

Identifier Type: -

Identifier Source: org_study_id