Laparoscopic Appendectomy Performed by junior SUrgeonS: impact of 3D visualization on surgical outcome. Randomized multicentre clinical trial. (LAPSUS TRIAL).
3D laparoscopy
3D technology
Laparoscopic appendectomy
Laparoscopic training
Young surgeons
Journal
Surgical endoscopy
ISSN: 1432-2218
Titre abrégé: Surg Endosc
Pays: Germany
ID NLM: 8806653
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
25
09
2019
accepted:
10
02
2020
pubmed:
16
2
2020
medline:
29
6
2021
entrez:
16
2
2020
Statut:
ppublish
Résumé
The purpose of this study was to evaluate the effect of 3D visualization applied to laparoscopic appendectomy (LA) performed by young surgeons (YS). We considered both operative features and clinical outcomes, aiming to highlight the benefits that this technology could bring to novice surgeons and their laparoscopic training. All the surgical procedures were performed by residents who had performed less than 20 appendectomies prior to the beginning of the study under the supervision of an expert surgeon. At the time of enrolment patients were randomized into two arms: Experimental arm (EA): laparoscopic appendectomy performed with laparoscopic 3D vision technology. Control arm (CA): laparoscopic appendectomy performed with the "standard" 2D technology. The primary endpoint was to find any statistically significant difference in operative time between the two arms. Differences in conversion rate, intra-operative complications, post-operative complications and surgeons' operative comfort were considered as secondary endpoints. We randomized 135 patients into the two study arms. The two groups were homogeneous for demographic characteristics, BMI and ASA scores. The characteristics of clinical presentation and anatomical position showed no significant difference. The operative time was longer in the CA (57.5 vs. 49.6 min, p = 0.048, 95% CI). In the subgroup of complicated appendicitis, this trend toward inferior operative time was confirmed without reaching statistical significance (2D = 60 min, 3D = 49.5 min, p = 0.082 95% CI). No intra-operative complications were observed in either group. The conversion rate was 5.6% (4 patients) in the 2D group and 4.6% (3 patients) in 3D group. The utilization of 3D laparoscopy was associated with reduction in operative time without influencing other parameters, in particular without altering the safety profile of the procedure.
Sections du résumé
BACKGROUND
The purpose of this study was to evaluate the effect of 3D visualization applied to laparoscopic appendectomy (LA) performed by young surgeons (YS). We considered both operative features and clinical outcomes, aiming to highlight the benefits that this technology could bring to novice surgeons and their laparoscopic training.
METHODS
All the surgical procedures were performed by residents who had performed less than 20 appendectomies prior to the beginning of the study under the supervision of an expert surgeon. At the time of enrolment patients were randomized into two arms: Experimental arm (EA): laparoscopic appendectomy performed with laparoscopic 3D vision technology. Control arm (CA): laparoscopic appendectomy performed with the "standard" 2D technology. The primary endpoint was to find any statistically significant difference in operative time between the two arms. Differences in conversion rate, intra-operative complications, post-operative complications and surgeons' operative comfort were considered as secondary endpoints.
RESULTS
We randomized 135 patients into the two study arms. The two groups were homogeneous for demographic characteristics, BMI and ASA scores. The characteristics of clinical presentation and anatomical position showed no significant difference. The operative time was longer in the CA (57.5 vs. 49.6 min, p = 0.048, 95% CI). In the subgroup of complicated appendicitis, this trend toward inferior operative time was confirmed without reaching statistical significance (2D = 60 min, 3D = 49.5 min, p = 0.082 95% CI). No intra-operative complications were observed in either group. The conversion rate was 5.6% (4 patients) in the 2D group and 4.6% (3 patients) in 3D group.
CONCLUSION
The utilization of 3D laparoscopy was associated with reduction in operative time without influencing other parameters, in particular without altering the safety profile of the procedure.
Identifiants
pubmed: 32060747
doi: 10.1007/s00464-020-07436-4
pii: 10.1007/s00464-020-07436-4
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
710-717Références
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