RecruitingNot ApplicableNCT05180864

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer


Sponsor

Amsterdam UMC

Enrollment

654 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical techniques during stomach cancer removal surgery: one that preserves the omentum (a fatty apron of tissue in the abdomen) versus one that removes it completely. Researchers want to find out if preserving the omentum is equally safe and leads to better recovery. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with resectable (removable) stomach (gastric) cancer - You are scheduled for partial or total stomach removal surgery with lymph node dissection - You are able to complete questionnaires in Dutch, English, or Italian - You are fit enough to undergo surgery (ASA class 1–3) **You may NOT be eligible if:** - Your cancer is very early stage (T1N0) and does not require omentectomy - Your cancer has grown into surrounding organs and requires multi-organ surgery - You are pregnant - You have had a previous stomach or omentum surgery (except for stomach perforation) - You have had a prior unrelated cancer that is not well controlled Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREGastrectomy

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

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NCT05180864


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