Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

Keimyung University

Status: Unknown

Conditions: Gastric Cancer; Metabolic Syndrome

Treatments: Procedure: Total omentectomy; Procedure: Omentum preserving

Study type: Interventional

Funder types: Other

Identifiers

NCT02641925

KSWEET-02 (Other Identifier)

2015-07-010

Details and patient eligibility

About

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.

Full description

The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving group.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Omentum preserving

Active Comparator group

Description:

Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed.

Treatment:

Procedure: Omentum preserving

Total omentectomy

Experimental group

Description:

Total omentectomy: Whole omentum will be removed.

Treatment:

Procedure: Total omentectomy