NCT03626493UnknownNot Applicable
A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy
Second Affiliated Hospital of Wenzhou Medical University1 site in 1 country105 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- the volume of hidden blood loss (mL)
Study Overview
Brief Summary
The aim of this cross-sectional study is to evaluate the hidden blood loss in patients who undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy and identity its risk factors.
Detailed Description
The electronic medical data of 105 patients who undergo laparoendoscopic single-site radical 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Volunteer to participate in the study with informed consent;
- •Females aged 20-80 who are confirmed with cervical cancer and are treated with laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy.
Exclusion Criteria
- •Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
- •Suspected or identified as other tumors of genital tract;
- •History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
- •Other diseases or heavy injuries that will interfere with the results;
- •Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Outcomes
Primary Outcomes
the volume of hidden blood loss (mL)
Time Frame: 10 months after the operation
the specific volume of hidden blood loss in patients after the operation applying Gross's formula
Secondary Outcomes
- the risk factors of hidden blood loss(10 months after the operation)
- the volume of total blood loss (mL)(10 months after surgery)
- the volume of visible blood loss (mL)(10 months after surgery)
Investigators
Study Sites (1)
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