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Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02641925
Enrollment
60
Registered
2015-12-30
Start date
2015-08-31
Completion date
2020-08-31
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Metabolic Syndrome

Keywords

Metabolic syndrome, gastric cancer, omentectomy

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.

Interventions

PROCEDUREOmentum preserving

The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.

PROCEDURETotal omentectomy

Whole omentum will be removed during gastrectomy with lymph node dissection.

Sponsors

Chonnam National University Hospital
CollaboratorOTHER
Dong-A University Hospital
CollaboratorOTHER
Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
HOMA-IR changepre-operative and post-operative 12monthsHOMA-IR change after operation

Secondary

MeasureTime frameDescription
prevalence of metabolic syndromepre-operative and post-operative 12monthscheck the presence of metabolic syndrome
Complicationwithin 30daysshort-term any complication related to surgery
HOMA-IR change according to anastomosis typepre-operative and post-operative 12monthscomparison between Billoth-II and Roux-en-Y

Countries

South Korea

Contacts

Primary ContactSeung Wan Ryu, M.D., Ph.D.
gsman@dsmc.or.kr82-53-250-7322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026