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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03628118
Other study ID # SAHoWMU-CR2018-07-130
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date September 1, 2022

Study information

Verified date October 2020
Source Second Affiliated Hospital of Wenzhou Medical University
Contact Qiong ZHANG, Ph.D
Phone 13587605820
Email joan_zhang2002@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this cross-sectional study is to evaluate the hidden blood loss in patients who underwent open radical hysterectomy and identity its risk factors.


Description:

The electronic medical data of 100 patients who undergo open radial hysterectomy in the following year to treat cervical cancer will be analyzed retrospectively in this study. The amount of hidden blood loss will be calculated according to Gross's formula. And multiple linear regression analysis will be employed to identify its risk factors.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 105
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Volunteer to participate in the study with informed consent; 2. Females aged 20-80 who are confirmed with cervical cancer and are treated with open radical hysterectomy and pelvic lymphadenectomy. Exclusion Criteria: 1. Pregnancy, lactation, postmenopause, or planned pregnancy within two years; 2. Suspected or identified as other tumors of genital tract; 3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 4. Other diseases or heavy injuries that will interfere with the results; 5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Study Design


Locations

Country Name City State
China TING LI Wenzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the volume of hidden blood loss (mL) the volume of invisible blood loss occurring in patients who undergo open radical hysterectomy applying Gross's formula 10 months after surgery
Secondary the risk factors of hidden blood loss Performing multiple linear regression analysis with SPSS 17.0, we plan to identify the factors which may increase the volume of hidden blood loss from possible factors like hypertension, diebetes, etc. 10 months after surgery
Secondary the volume of total blood loss (mL) the vomule of patients' blood loss through the whole perioperative time according to the method of Nadler 10 months after surgery
Secondary the volume of visible blood loss (mL) the visible blood loss including the blood in the suction bottle and in weighed compresses during the operation and the drainage volume after the operation 10 months after surgery
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