About this trial
European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2).
Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed.
The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older than 18 years old
Resectable gastric cancer
Gastric cancer T3-4 N+/- M0
Disqualifiers
M1
Non surgical patients for medical status
Non resectable gastric cancer during surgery
Endoscopic resectable gastric cancer
Trial design
Parallel
Treatments tested in this trial
Surgery procedure
Other interventionOmentectomy vs omental preservations during gastric surgery
Treatment groups
Trial outcomes
Primary outcomes
disease free interval
time between surgery and recurrence. Units of measure: months
Secondary outcomes
global survival
survival between surgery and last follow-up date. Units of measure: percentage
survival at 5 years
survival between surgery and 5 years. Units of measure: percentage
complications - CCI
type of complications and CCI number. Units of measure: enter number between 1 and 100
postoperatory mortality
mortality after surgery. Units of measure: percentage
Locations
Sponsors and contacts
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