Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT02541461
Brief Summary:
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.
Detailed Description:
* 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.
Study:
NCT02541461
Study Brief:
Protocol Section:
NCT02541461