Omentectomy in Radical Gastrectomy for Gastric Cancer Trial

Stomach Neoplasms Clinical Trial

— OMEGA  

Official title:

Omentectomy in Radical Gastrectomy for Gastric Cancer Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050659
• Other study ID #: OMEGA
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: March 9, 2015
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

In patients with gastric cancer, traditionally a complete omentectomy is performed as part of a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases operation time significantly, especially in laparoscopic procedures. Patients remain more vulnerable for peritoneal infections and intestinal adhesions following omentectomy. Furthermore one can debate whether a complete omentectomy is indicated from an oncologic viewpoint. In the present study we prospectively evaluated the presence of tumor load in the greater omentum of patients with potentially curative gastric cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• an in potentially curative gastric cancer

• age > 18 year

Exclusion Criteria:

• palliative resection

• age < 18 year

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Omentum
• Stomach Neoplasms

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumorload in the greater omentum		at the time of pathologic investigation	No