The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- HOMA-IR change
Study Overview
Brief Summary
Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure during a surgery for early gastric cancer, the investigators will divide patients randomly into two groups, total omentectomy group and omentum preserving group.
Detailed Description
The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed adenocarcinoma in stomach
- •Aged≥20 years and ≤80 years
- •Scheduled as laparoscopic distal gastrectomy (cT1N0M0 or cT2N0M0)
- •Metabolic syndrome (NCEP:ATP III (National Cholesterol Education Program and Adult Treatment Panel III) -harmonizing definition criteria
- •ECOG 0 (Eastern Cooperative Oncology Group)
- •ASA score class I-III (American Society of Anesthesiologists)
- •patient has given their written informed consent to participate in the study
Exclusion Criteria
- •Simultaneously combined resection of other organ
- •Active other malignancy
- •Expected to severe intra-abdominal adhesion due to previous abdominal operation history
- •Uncontrolled co-morbidity
- •Vulnerable patients
Arms & Interventions
Omentum preserving
Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed.
Intervention: Omentum preserving (Procedure)
Total omentectomy
Total omentectomy: Whole omentum will be removed.
Intervention: Total omentectomy (Procedure)
Outcomes
Primary Outcomes
HOMA-IR change
Time Frame: pre-operative and post-operative 12months
HOMA-IR change after operation
Secondary Outcomes
- Complication(within 30days)
- prevalence of metabolic syndrome(pre-operative and post-operative 12months)
- HOMA-IR change according to anastomosis type(pre-operative and post-operative 12months)
Investigators
Seung Wan Ryu
Director of Gastrointesinal surgery, associate professor
Keimyung University Dongsan Medical Center