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

NCT03154164 | Completed

• 1 other identifier: LEFFE
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystolithiasis

Outcome Measures

Primary Outcomes (1)

• Dissection time

  Time required to dissect the gallbladder from the liver

  6 hours

Secondary Outcomes (4)

• Level of technical complexity

  6 hours

• Level of technical performance

  6 hours

• Technical performance

  6 hours

• Complication rate

  30 days

Interventions

Ultrasonic tissue coagulation dissection DEVICE

ultrasonic coagulation for dissection during laparoscopic cholecystectomy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic cholecystectomy

You may qualify if:

• Preoperatively discovered choledocholithiasis

You may not qualify if:

• Symptoms and signs of acute or chronic cholecystitis

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: May 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)