Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-09 @ 3:37 PM
Study NCT ID:
NCT02800005
Status:
UNKNOWN
Last Update Posted:
2017-12-11
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer
Sponsor:
Jian-Kun Hu
Organization:
Study Overview
Official Title:
Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer Patients: a Single Center Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As the number of obesity continues to increase, surgical oncologist pay more attention to the effect of obesity on surgical outcomes and survival of digestive systemin cancers. Body mass index(BMI) is one of the most widely used measurements of obesity. Abdominal fat area (AFA) calculated by computed tomography is popular because of its validity of fat distribution. There is still no consensus which of BMI and AFA could be the more effective measurement and more accurate to evaluate effect of obesity on surgical outcomes and survival. Gastric cancer is one of the most common digestive system cancers, and gastrectomy is the primary therapeutic options.It is important to compare the different measurements(BMI or AFA) to assess obesity and effect on surgical outcome and survival for gastric cancer patients.
Detailed Description:
Standard operation procedure（SOP）
1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
2. Procedures: The surgical treatments is adopted total or subtotal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3.
3. Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
4. Follow-up: Follow-up will last to 5-year of the postoperative period. The postoperative complications is graded by the clavian-dildo classification. The postoperative complications and quality of life (change of AFA,performance status, recurrence and overall survival)are the focus of this study.
1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
2. Procedures: The surgical treatments is adopted total or subtotal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3.
3. Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
4. Follow-up: Follow-up will last to 5-year of the postoperative period. The postoperative complications is graded by the clavian-dildo classification. The postoperative complications and quality of life (change of AFA,performance status, recurrence and overall survival)are the focus of this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: