Body Composition After Laparoscopic Gastrectomy for Gastric Cancer

August 10, 2018 updated by: Ji Young Kim, Hanyang University Seoul Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Non-Obese
Patients who underwent laparoscopic gastrectomy and with BMI < 25 kg/m2
Procedure: Laparoscopic gastrectomy
(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
OTHER: Obese
Patients who underwent laparoscopic gastrectomy and with BMI ≥ 25 kg/m2
Procedure: Laparoscopic gastrectomy
(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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-surgery, 6 and 12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-surgery, 6 and 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University Seoul Hospital

Investigators

  • Principal Investigator: Yun Young Choi, MD, PhD, Hanyang University Seoul Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (ESTIMATE)

September 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-04-026-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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