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

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ClinicalTrials.gov Identifier: NCT03154164
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriel Sandblom, 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.

Condition or disease Intervention/treatment
Cholecystolithiasis Device: Ultrasonic tissue coagulation dissection

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.


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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study on the Learning Curve for Fundus First With Ultrasonic Tissue Coagulation in Elective Cholecystectomy
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones


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


Primary Outcome Measures :
  1. Operative time [ Time Frame: 6 hours ]
    Time required to complete the procedure


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing laparoscopic cholecystectomy
Criteria

Inclusion Criteria:

  • Preoperatively discovered choledocholithiasis

Exclusion Criteria:

  • Symptoms and signs of acute or chronic cholecystitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154164


Contacts
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Contact: My Blohm, MD +46702900521 my.blohm@ltdalarna.se
Contact: Gabriel Sandblom, Ass Prof +46704158218 gabriel.sandblom@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Gabriel Sandblom, Ass Prof    +46704158218    gabriel.sandblom@ki.se   
Sponsors and Collaborators
Karolinska Institutet

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Responsible Party: Gabriel Sandblom, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03154164     History of Changes
Other Study ID Numbers: LEFFE
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be saved and analysed after anonymising the participant.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical