Skip to main content
OpenTrials
Completed

NCT Number: NCT02541461

Body Composition After Laparoscopic Gastrectomy for Gastric Cancer

Nutritional status including changes of body composition is one of the most important clinical determinants of outcome after gastrectomy for gastric cancer. Various type of gastric operations are widely used with favorable outcome in South Korea. It was reported that several advantages of laparoscopic gastrectomy are the prevention of overt weight loss and enhanced recovery of muscle mass at 6 months after surgery. But there have been no longitudinal studies evaluating changes in the body composition according to the different type of anastomosis of laparoscopic gastrectomy.

The purpose of this prospective study was to investigate changes in lipid indices associated with whole body composition during 1 year of follow-up after laparoscopic gastrectomy. Gastrectomy resulted in improved lipid indices and a reduction in body weight, fat and LBM. The HDL-Csignificantly increased in the non-obese group for 1 year after gastrectomy and the reduction of TG level was positively correlated with fat, especially with trunk fat.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanyang University Seoul Hospital

Seoul, South Korea

About this study

  • All patients will undergo a laparoscopic gastrectomy for their gastric cancer (proved to be stage I or II) or benign gastric neoplasm by preoperative screening diagnostic procedure. They will receive laparoscopic gastrectomy as follows: (1) wedge resection, subtotal or total gastrectomy with or without lymph node dissection; (2) R0 resection; (3) laparoscopic gastrectomy; (4 gastroduodenal anastomosis or duodenal bypass, including Roux-en-Y or gastrojejunostomy.
  • Pre-operative, 6 and 12 months post-operative body composition measurement will be performed on each patient. The whole body composition measurement will be assessed by Hologic 4500/A dual energy X-ray absorptiometry system. The software performs calculations of the differential attenuations of the two photon energies and present data of percentage of fat, fat mass (g), lean mass (g), bone mineral content (g), bone mineral density (g/cm2), and total mass (g).
  • Laboratory analysis - There is a battery of labs that are ordered in both the pre-operative, 6 and 12 months post-operative time frame. These labs are ordered independent of the patient's participation in the study. These labs are ordered to evaluate and to assist management of the patient's medical comorbidities as well as to assess for adequate nutritional intake and balance.
  • Queries on nutritional intake and exercise will be made at each post-operative appointment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with gastric cancer or benign gastric neoplasm planning gastric operation
  • Stage I and II patients by preoperative screening

Exclusion criteria

  • Distant metastasis
  • Severe comorbidity
  • Malnourished state
  • Inability of access to enteral feeding

Treatment and study plan

Laparoscopic Gastrectomy

Procedure

(1) Wedge resection, subtotal or total gastrectomy with or without lymph node dissection; (2) R0 resection; (3) Laparoscopic gastrectomy; (4) Gastroduodenal anastomosis or duodenal bypass, including Roux-en-Y or gastrojejunostomy

Primary outcomes

  1. Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic)

    Time frame: pre-surgery, 6 and 12 months post-surgery

    Using DEXA machine produced by Hologic (QDR 4500), changes in lean tissue mass and fatty tissue mass following gastric operation assessed

Secondary outcomes

  1. Changes in lipid profile

    Time frame: pre-surgery, 6 and 12 months post-surgery

    Using laboratory analysis, changes in the lipid profiles (total cholesterol (TC), triglyceride (TG), LDL-C and HDL-C) following gastric operation assessed

Sponsors and collaborators

Lead sponsor

Hanyang University Seoul Hospital

Other

Registry information

Official study title

Changes in Lipid Indices and Body Composition One Year After Laparoscopic Gastrectomy: a Prospective Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 4, 2015
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.