Skip to main content
OpenTrials
Completed

NCT Number: NCT03154164

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cholecystolithiasis Biliary Tract Diseases Cholelithiasis Digestive System Diseases Gallbladder Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preoperatively discovered choledocholithiasis

Exclusion criteria

  • Symptoms and signs of acute or chronic cholecystitis

Treatment and study plan

Ultrasonic tissue coagulation dissection

Device

ultrasonic coagulation for dissection during laparoscopic cholecystectomy

Primary outcomes

  1. Dissection time

    Time frame: 6 hours

    Time required to dissect the gallbladder from the liver

Secondary outcomes

  1. Level of technical complexity

    Time frame: 6 hours

    Level of technical complexity of the procedure assessed by the surgeon

  2. Level of technical performance

    Time frame: 6 hours

    Level of technical performance during the procedure assessed by the surgeon

  3. Technical performance

    Time frame: 6 hours

    Intraoperative technical performance assessed by an independent observer

  4. Complication rate

    Time frame: 30 days

    Intra- and postoperative complication rate

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: LEFFE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 16, 2017
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.