Last reviewed · How we verify
NCT04863482: SCOTCH
Safety of Laparoscopic ChOlecystectomy Performed by Trainee Surgeons With Different CHolangiographic Techniques
NA trial testing IOC in Cholecystitis; Gallstone in 1,500 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | Università Politecnica delle Marche |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,500 |
| Start date | 1 June 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- IOC — full drug profile →
Conditions studied
- Cholecystitis; Gallstone — all drugs for Cholecystitis; Gallstone →
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):
-
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:
- PubMed search for NCT04863482
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04863482 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Università Politecnica delle Marche
- Last refreshed: 8 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04863482.
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