- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04490668
Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery
Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical postoperative complication. Anastomotic leakage severely compromises the recovery after surgery. It increases the overall burden of patients and hospital resources. Postoperative mortality is higher in patients with anastomotic leakage.
Human albumin is routinely administered after surgery with a unproven hypothesis that the human albumin is beneficial to prevent anastomotic leakage. We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Histologically confirmed gastric cancer
- Patients who underwent radical gastrectomy
Exclusion Criteria:
- Patient who did not undergo gastrectomy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Human albumin support
Patients who received intravenous human albumin after gastric cancer surgery
|
Patients received intravenous human albumin after gastric cancer surgery.
Overall quantity of human albumin were recorded.
|
No human albumin support
Patients who did not receive intravenous human albumin after gastric cancer surgery
|
Patients received intravenous human albumin after gastric cancer surgery.
Overall quantity of human albumin were recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the rate of anastomotic leakage
Time Frame: Up to one months after the discharge of last patient
|
The rate of anastomotic leakage were compared among both groups
|
Up to one months after the discharge of last patient
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJ-GC-Postop-complication 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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