The Effects of Preoperative Bevacizumab on Perioperative Complications

NCT04788381 | Unknown FDA Drug

• 1 other identifier: RWS-CRC-LC-S
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a nationwide multicenter,retrospective,observational real-world study.

1. 1.To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation.
2. 2.To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications.
3. 3.To explore the risk factors of perioperative comlications in patients with tumor received bevacizumab prior to unexpected operation.

Conditions

Colorectal Cancer; Lung Cancer; Operation Wound; Infection; Bevacizumab

Keywords

bevacizumab

Outcome Measures

Primary Outcomes (1)

• To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation.

  To 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 events;To calculate the incidence of each perioperative complication in patients undergoing unexpected operation after bevacizumab discontinuation.

  30 days after operation

Secondary Outcomes (1)

• To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications.

  30 days after operation

Study Arms (1)

Participants with CRC or lung cancer was performed unexpected operation

This is an observational study; thus, no intervention or treatment is required by the protocol. During the study, enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation.

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation.

Also known as: Avastin

Participants with CRC or lung cancer was performed unexpected operation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with colorectal canceror lung cancer who underwent unexpected operation within 6 weeks (including 6 weeks) of bevacizumab discontinuation.

You may qualify if:

• Patients with colorectal cancer and lung cancer who underwent unexpected operation from 01 Jan 2010 to 31 Dec 2019, and received bevacizumab within 6 weeks (including 6 weeks) before operation;
• Patients aged 18-90 years old;
• Complete clinical data related to important indicators, including preoperative baseline data, surgical information and perioperative prognosis information.

You may not qualify if:

• Patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to unexcepted operation.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 0571, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Surgical Wound Infection

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Su Zhan Zhang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Su Zhan Zhang, PhD

CONTACT

008613600511585; zrsj@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Institute of Zhejiang University

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: April 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: July 31, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

CN (1)