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Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
Sponsor: Amsterdam UMC
Summary
Curative therapy for gastric cancer usually consists of perioperative chemotherapy and a radical (R0) gastrectomy. A radical resection includes a modified D2 lymphadenectomy, and, generally, a complete omentectomy, to ensure the removal of omental metastatic lymph nodes and tumor deposits. The omentum has some essential functions within the peritoneal cavity. The omentum functions as regulator of regional immune responses to prevent infections and, additionally, it prevents adhesions that can lead to small bowel obstruction. Omentectomy is associated with increased incidence of early and late postoperative complications such as abdominal abscess, ileus, and wound infections in various types of surgery. There is little evidence regarding survival benefit of routine complete omentectomy during gastrectomy. The investigators hypothesize that omitting a complete omentectomy (and instead preserve the greater omentum distal of the gastroepiploic arcade) during gastrectomy for cancer does not negatively impact survival. OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Adult patients (\>18 years) with primary resectable gastric cancer, clinical stage T2-4a N0-3 M0 or cT1N+ scheduled for open or minimally invasive (sub)total gastrectomy are included. The primary study objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
654
Start Date
2024-03-01
Completion Date
2031-01-01
Last Updated
2025-09-04
Healthy Volunteers
No
Conditions
Interventions
Gastrectomy
Open or minimally invasive (sub)total gastrectomy
Locations (16)
University Medical Center of the Johannes Gutenberg University
Mainz, Germany
Azienda Ospedaliera Universitaria
Siena, Italy
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Ziekenhuis Groep Twente
Almelo, Netherlands
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Gelre ziekenhuis
Apeldoorn, Netherlands
Rijnstate ziekenhuis
Arnhem, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Universitait Medisch Centrum Groningen
Groningen, Netherlands
Zuyderland ziekenhuis
Heerlen, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Elisabeth Tweesteden ziekenhuis
Tilburg, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Oxford University Hospitals
Oxford, United Kingdom