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NCT03143426
Does 3D Visualisation Improve Performance of Laparoscopic Cholecystectomy by Junior Surgeons?
NA trial testing 3D laparoscopic cholecystectomy in Complication Laparoscopic Cholecystectomy in 100 participants. Completed in 30 September 2017.
30 September 2017
Quick facts
| Lead sponsor | Clinical Research Centre, Malaysia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 1 April 2017 |
| Primary completion | 30 September 2017 |
| Estimated completion | 30 September 2017 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- 3D laparoscopic cholecystectomy
Conditions studied
- Complication Laparoscopic Cholecystectomy — all drugs for Complication Laparoscopic Cholecystectomy →
- Conversion Laparoscopic to Open Cholecystectomy — all drugs for Conversion Laparoscopic to Open Cholecystectomy →
Sponsor
Clinical Research Centre, Malaysia
Who can join
18 and older, any sex, with Complication Laparoscopic Cholecystectomy or Conversion Laparoscopic to Open Cholecystectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal surgery in Western countries. Ever since the introduction of laparoscopic surgery in the late 1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the introduction and refinement of other laparoscopic abdominal surgeries have rapidly progressed due to the early experience and safety profile seen in LC. The introduction of stereoscopes which allow for 3D visual feedback has been postulated to overcome setbacks encountered in conventional 2-dimensional (2D) laparoscopic surgery. Since its introduction in the mid-2000s, 3D visualisation has been proven to be advantageous over 2D visualisation, especially so within the context of training junior surgeons in controlled, experimental settings. The body of evidence on benefits of 3D visualisation within the clinical setting, i.e. when applied on live patients in operating theatres, remains small and weak. The previous publications however did not extrapolate any potential benefits on patients' well-being in correlation to their reported benefits and neither did they explore any potential benefits in reducing operative complications. We decided to embark on a study to investigate any peri-operative advantage conferred on junior surgeons in performing LC using 3D visualisation as the majority of LCs in Sibu Hospital are carried out by junior surgeons.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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 NCT03143426 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Clinical Research Centre, Malaysia
- Last refreshed: 26 January 2018
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/NCT03143426.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing