Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788381
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2021-03-05
Brief Title:
The Effects of Preoperative Bevacizumab on Perioperative Complications
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
The Effects of Preoperative Bevacizumab on Perioperative Complications in Patients With Tumor Undergoing Unexpected Operation
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_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:
This is a nationwide multicenterretrospectiveobservational real-world study
1 To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation
2 To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications
3 To explore the risk factors of perioperative comlications in patients with tumor received bevacizumab prior to unexpected operation
1 To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation
2 To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications
3 To explore the risk factors of perioperative comlications in patients with tumor received bevacizumab prior to unexpected operation
Detailed Description:
Avastin bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factorVEGF in in vitro and in vivo assay systems Bevacizumab was first granted marketing approval in the United States on 26 February 2004 international birth date in combination with IV 5-fluorouracil5-FU based chemotherapy for the first-line treatment of patients with metastatic carcinoma of the colon or rectum CRC At present bevacizumab is widely used in the treatment of solid tumors such as lung cancer colorectal cancer and so on It has been reported in the literature that bevacizumab may adversely affect wound healing To prevent postoperative complications some guidelines state that the interval time between last dose of bevacizumab and operations should be at least 6 weeks but the optimal time to discontinue bevacizumab before surgery has not been confirmed This project aims to evaluate the risk of perioperative complications in cancer patients with a history of bevacizumab use within 6 weeks prior to unexpected operation
This is a nationwide multicenterretrospectiveobservational real-world studyThe study will collect the medical records and prognosis in 30 days following surgery of patients with colorectal cancer and lung cancer who underwent unexpected operation within 6 weeks including 6 weeks of bevacizumab discontinuation from 01 Jan 2010 to 31 Dec 2019All enrolled subjects aged 18-90 years old Complete clinical data related to important indicators including preoperative baseline data surgical information and perioperative prognosis information The patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to surgery would be excluded
Primary Evaluation Measures To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operationto calculate the total incidence of perioperative complications in patients undergoing unexpected surgery after discontinuation of bevacizumab including wound healing complications non-wound-related infections postoperative bleeding thrombosis gastrointestinal perforation anastomotic leakage secondary surgery death and other perioperative adverse eventsto calculate the incidence of each perioperative complication in patients undergoing unexpected operation after bevacizumab discontinuation
SAS94 statistical analysis software will be used for analysis Measurement indicators will be statistically described using number of cases mean median standard deviation minimum and maximum categorical indicators will be statistically described using frequency and percentage Unless otherwise specified all statistical tests will adopt the two-sided test with α 005 and the corresponding OR value and two-sided 95 confidence interval will be provided if applicable
This is a nationwide multicenterretrospectiveobservational real-world studyThe study will collect the medical records and prognosis in 30 days following surgery of patients with colorectal cancer and lung cancer who underwent unexpected operation within 6 weeks including 6 weeks of bevacizumab discontinuation from 01 Jan 2010 to 31 Dec 2019All enrolled subjects aged 18-90 years old Complete clinical data related to important indicators including preoperative baseline data surgical information and perioperative prognosis information The patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to surgery would be excluded
Primary Evaluation Measures To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operationto calculate the total incidence of perioperative complications in patients undergoing unexpected surgery after discontinuation of bevacizumab including wound healing complications non-wound-related infections postoperative bleeding thrombosis gastrointestinal perforation anastomotic leakage secondary surgery death and other perioperative adverse eventsto calculate the incidence of each perioperative complication in patients undergoing unexpected operation after bevacizumab discontinuation
SAS94 statistical analysis software will be used for analysis Measurement indicators will be statistically described using number of cases mean median standard deviation minimum and maximum categorical indicators will be statistically described using frequency and percentage Unless otherwise specified all statistical tests will adopt the two-sided test with α 005 and the corresponding OR value and two-sided 95 confidence interval will be provided if applicable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None