Short-Term Surgical Outcomes of Robotic Gastrectomy Compared to Open Gastrectomy for Patients with Gastric Cancer: a Randomized Trial.
DaVinci system
Gastric cancer
Open surgery
Randomized clinical trial
Robotic surgery
Short-term surgical outcome
Journal
Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract
ISSN: 1873-4626
Titre abrégé: J Gastrointest Surg
Pays: United States
ID NLM: 9706084
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
received:
19
05
2022
accepted:
13
08
2022
pubmed:
21
9
2022
medline:
23
11
2022
entrez:
20
9
2022
Statut:
ppublish
Résumé
Robotic gastrectomy (RG) has been shown to be a safe and feasible method in gastric cancer (GC) treatment. However, most studies are in Eastern cohorts and there is great interest in knowing whether the method can be used routinely, especially in the West. The aim of this study was to compare the short-term surgical outcomes of D2-gastrectomy by RG versus open gastrectomy (OG). Single-institution, open-label, non-inferiority, randomized clinical trial performed between 2015 and 2020. GC patients were randomized (1:1 allocation) to surgical treatment by RG or OG. Da Vinci Si platform was used. gastric adenocarcinoma, stage cT2-4 cN0-1, potentially curative surgery, age 18-80 years, and ECOG performance status 0-1. emergency surgery and previous gastric or major abdominal surgery. Primary endpoint was short-term surgical outcomes. The study is registered at clinicaltrials.gov (NCT02292914). Of 65 randomized patients, 5 were excluded (3 palliatives, 1 obstruction and emergency surgery, and 1 for material shortage). Consequently, 31 and 29 patients were included for final analysis in the OG and RG groups, respectively. No differences were observed between groups regarding age, sex, BMI, comorbidities, ASA, and frequency of total gastrectomy. RG had similar mean number of harvested lymph nodes (p = 0.805), longer surgical time (p < 0.001), and less bleeding (p < 0.001) compared to OG. Postoperative complications, length of hospital stay, and readmissions in 30 days were equivalent between OG and RG. RG reduces operative bleeding by more than 50%. The short-term outcomes were non-inferior to OG, although surgical time was longer in RG.
Sections du résumé
BACKGROUND
Robotic gastrectomy (RG) has been shown to be a safe and feasible method in gastric cancer (GC) treatment. However, most studies are in Eastern cohorts and there is great interest in knowing whether the method can be used routinely, especially in the West.
OBJECTIVES
The aim of this study was to compare the short-term surgical outcomes of D2-gastrectomy by RG versus open gastrectomy (OG).
METHODS
Single-institution, open-label, non-inferiority, randomized clinical trial performed between 2015 and 2020. GC patients were randomized (1:1 allocation) to surgical treatment by RG or OG. Da Vinci Si platform was used.
INCLUSION CRITERIA
gastric adenocarcinoma, stage cT2-4 cN0-1, potentially curative surgery, age 18-80 years, and ECOG performance status 0-1.
EXCLUSION CRITERIA
emergency surgery and previous gastric or major abdominal surgery. Primary endpoint was short-term surgical outcomes. The study is registered at clinicaltrials.gov (NCT02292914).
RESULTS
Of 65 randomized patients, 5 were excluded (3 palliatives, 1 obstruction and emergency surgery, and 1 for material shortage). Consequently, 31 and 29 patients were included for final analysis in the OG and RG groups, respectively. No differences were observed between groups regarding age, sex, BMI, comorbidities, ASA, and frequency of total gastrectomy. RG had similar mean number of harvested lymph nodes (p = 0.805), longer surgical time (p < 0.001), and less bleeding (p < 0.001) compared to OG. Postoperative complications, length of hospital stay, and readmissions in 30 days were equivalent between OG and RG.
CONCLUSIONS
RG reduces operative bleeding by more than 50%. The short-term outcomes were non-inferior to OG, although surgical time was longer in RG.
Identifiants
pubmed: 36127557
doi: 10.1007/s11605-022-05448-0
pii: 10.1007/s11605-022-05448-0
doi:
Banques de données
ClinicalTrials.gov
['NCT02292914']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2477-2485Informations de copyright
© 2022. The Society for Surgery of the Alimentary Tract.
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