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NCT04863482: SCOTCH

Safety of Laparoscopic ChOlecystectomy Performed by Trainee Surgeons With Different CHolangiographic Techniques

Status unknown NA Last updated 8 October 2021
What this trial tests

NA trial testing IOC in Cholecystitis; Gallstone in 1,500 participants. Status unknown.

Timeline
1 June 2021
Primary endpoint
31 December 2021
31 December 2021

Quick facts

Lead sponsorUniversità Politecnica delle Marche
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment1,500
Start date1 June 2021
Primary completion31 December 2021
Estimated completion31 December 2021
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Università Politecnica delle Marche — full company profile →

Who can join

Adults 18 to 99, any sex, with Cholecystitis; Gallstone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Laparoscopic cholecystectomy (LC) gained popularity among general surgeons in 1990s and rapidly become one of the most commonly performed procedures in digestive surgery, with more than one million cholecystectomies being performed in the United States per year. LC remains also one of the most commonly performed procedure by general surgeons during the training period. Even if previous report LC cases performed by surgical trainees (ST) are not associated with higher operative morbidity, the length of operative time is significantly increased when compared with that of LC cases performed by attending surgeons, due, most of all, to difficulties in identifying the anatomical structure, and this sometimes leads to an attending surgeon taking away the case from the trainee. Furthermore, despite the fact that LC has proven to be a safe procedure, the rate of common bile duct (BDI) injury still remains unacceptably high even in the hands of minimally invasive trained surgeons ranging from 0.2 to 1.5% in individual reports, much higher than initial reports, associated with significant morbidity and mortality, lower quality of life and increased costs, related to additional health care measures, loss of work days, and insurance claims. The aim of this study is to address which of the techniques now available could be addressed as the best option in a training setting to enhance the learning curve, to ideally build a safe cholecystectomy training program and virtually eliminate the risk of BDI due to anatomic misinterpretation during the training period.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Safety of laparoscopic cholecystectomy performed by trainee surgeons with different cholangiographic techniques (SCOTCH): a prospective non-randomized trial on the impact of fluorescent cholangiography during laparoscopic cholecystectomy performed by trainees.
    Ortenzi M, Corallino D, Botteri E, Balla A, et al · · 2024 · cited 6× · PMID 38135732 · DOI 10.1007/s00464-023-10613-w

Verify or expand the search:

Other trials of IOC

Trials testing the same drug.

Other recruiting trials for Cholecystitis; Gallstone

Currently open trials in the same condition.

Other Università Politecnica delle Marche trials

Trials by the same sponsor.

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Data sources for this page

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