Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01345773
Status:
COMPLETED
Last Update Posted:
2011-11-17
First Post:
2011-04-29
Brief Title:
Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer a Prospective Study
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
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:
Venous thromboembolism VTE has considerably harmful effects on morbidity and mortality of cancer patients Several guidelines recommendations have been made about the use of anticoagulation for the prevention and treatment of VTE in Western patients with cancer In Western VTE guidelines all solid cancer patients receiving abdominal major surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such as low molecular weight heparin LMWH in the perioperative periods These guideline recommendations are based on high incidence of postoperative VTE development in Western cancer patients However there have been many cumulative data about the effect of different ethnicity on the VTE development and more and more investigators and clinicians admit that Asian ethnicity has lower incidence of VTE than Western ethnicity Therefore it may not be advisable to apply Western guidelines as it is to the clinical situation of Asian cancer patients
Although gastric cancer is the common cancer in Asia there is no prospective data on the incidence of VTE development during the postoperative period of gastric cancer surgery In other words Asian doctors including Korean clinicians dont know the exact incidence of surgery-related VTE From their clinical experiences most Korean surgeons think that the incidence of postoperative VTE development is rare They also have much concern about the complications such as bleeding that might be caused by routine use of pharmacologic thromboprophylaxis during the perioperative periods Therefore in most clinical situation Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW Considering these clinical situations in Korea the uncritical acceptance of Western guidelines is inappropriate The necessity of pharmacologic thrombo-prophylaxis can be answered only from the results of the prospective study on the incidence of postoperative VTE development after gastric cancer surgery Moreover current surgical trend in cancer patients is minimally invasive approach such as laparoscopic surgery However the necessity of pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not been evaluated even in Western countries Western guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving laparoscopic cancer surgery On above backgrounds this study was designed
Although gastric cancer is the common cancer in Asia there is no prospective data on the incidence of VTE development during the postoperative period of gastric cancer surgery In other words Asian doctors including Korean clinicians dont know the exact incidence of surgery-related VTE From their clinical experiences most Korean surgeons think that the incidence of postoperative VTE development is rare They also have much concern about the complications such as bleeding that might be caused by routine use of pharmacologic thromboprophylaxis during the perioperative periods Therefore in most clinical situation Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW Considering these clinical situations in Korea the uncritical acceptance of Western guidelines is inappropriate The necessity of pharmacologic thrombo-prophylaxis can be answered only from the results of the prospective study on the incidence of postoperative VTE development after gastric cancer surgery Moreover current surgical trend in cancer patients is minimally invasive approach such as laparoscopic surgery However the necessity of pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not been evaluated even in Western countries Western guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving laparoscopic cancer surgery On above backgrounds this study was designed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None