Omentectomy for Metabolic Syndrome in Gastric Cancer Patients
NCT ID: NCT02641925
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-08-31
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Omentum preserving
Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed.
Omentum preserving
The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.
Total omentectomy
Total omentectomy: Whole omentum will be removed.
Total omentectomy
Whole omentum will be removed during gastrectomy with lymph node dissection.
Interventions
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Omentum preserving
The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.
Total omentectomy
Whole omentum will be removed during gastrectomy with lymph node dissection.
Eligibility Criteria
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Inclusion Criteria
* 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
* Active other malignancy
* Expected to severe intra-abdominal adhesion due to previous abdominal operation history
* Uncontrolled co-morbidity
* Vulnerable patients
20 Years
80 Years
ALL
No
Sponsors
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Chonnam National University Hospital
OTHER
Dong-A University Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Responsible Party
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Seung Wan Ryu
Director of Gastrointesinal surgery, associate professor
Principal Investigators
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Seung Wan Ryu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korean South West East Gastric Surgery Group
Locations
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Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Dong-A University Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Young Kyu Park, MD, PhD
Role: primary
Min Chan Kim, MD, PhD
Role: primary
References
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An JY, Kim YM, Yun MA, Jeon BH, Noh SH. Improvement of type 2 diabetes mellitus after gastric cancer surgery: short-term outcome analysis after gastrectomy. World J Gastroenterol. 2013 Dec 28;19(48):9410-7. doi: 10.3748/wjg.v19.i48.9410.
Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Baracat J, Geloneze B. Visceral fat resection in humans: effect on insulin sensitivity, beta-cell function, adipokines, and inflammatory markers. Obesity (Silver Spring). 2013 Mar;21(3):E182-9. doi: 10.1002/oby.20030.
Lottati M, Kolka CM, Stefanovski D, Kirkman EL, Bergman RN. Greater omentectomy improves insulin sensitivity in nonobese dogs. Obesity (Silver Spring). 2009 Apr;17(4):674-80. doi: 10.1038/oby.2008.642. Epub 2009 Feb 12.
Sdralis E, Argentou M, Mead N, Kehagias I, Alexandridis T, Kalfarentzos F. A prospective randomized study comparing patients with morbid obesity submitted to sleeve gastrectomy with or without omentectomy. Obes Surg. 2013 Jul;23(7):965-71. doi: 10.1007/s11695-013-0925-z.
Tchernof A, Despres JP. Pathophysiology of human visceral obesity: an update. Physiol Rev. 2013 Jan;93(1):359-404. doi: 10.1152/physrev.00033.2011.
Thorne A, Lonnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9. doi: 10.1038/sj.ijo.0801871.
Herrera MF, Pantoja JP, Velazquez-Fernandez D, Cabiedes J, Aguilar-Salinas C, Garcia-Garcia E, Rivas A, Villeda C, Hernandez-Ramirez DF, Davila A, Zarain A. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care. 2010 Jul;33(7):1413-8. doi: 10.2337/dc09-1833.
Other Identifiers
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KSWEET-02
Identifier Type: OTHER
Identifier Source: secondary_id
2015-07-010
Identifier Type: -
Identifier Source: org_study_id
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