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

Completed

• Conditions: Cholecystolithiasis

• Registration Number: NCT03154164
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Preoperatively discovered choledocholithiasis

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Exclusion Criteria

• Symptoms and signs of acute or chronic cholecystitis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dissection time	6 hours	Time required to dissect the gallbladder from the liver

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden