Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

Not Applicable

• Conditions: Metabolic Syndrome; Gastric Cancer
• Interventions: Procedure: Total omentectomy; Procedure: Omentum preserving

• Registration Number: NCT02641925
• Lead Sponsor: Keimyung University Dongsan Medical Center

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01
• Primary Completion: 2019-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total omentectomy	Total omentectomy	Total omentectomy: Whole omentum will be removed.
Omentum preserving	Omentum preserving	Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed.

Primary Outcome Measures

Name	Time	Method
HOMA-IR change	pre-operative and post-operative 12months	HOMA-IR change after operation

Secondary Outcome Measures

Name	Time	Method
prevalence of metabolic syndrome	pre-operative and post-operative 12months	check the presence of metabolic syndrome
Complication	within 30days	short-term any complication related to surgery
HOMA-IR change according to anastomosis type	pre-operative and post-operative 12months	comparison between Billoth-II and Roux-en-Y

Trial Locations

Locations (3)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Jeollanam-do, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of