A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy

Radical Hysterectomy Clinical Trial

Official title:

A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03626493
• Other study ID #: SAHoWMU-CR2018-07-131
• Status: Not yet recruiting
• 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
• Study type: Observational

Clinical Trial 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.

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.

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 laparoendoscopic single-site radical hysterectomy with 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.

Related Conditions & MeSH terms

• Hemorrhage
• Hidden Blood Loss
• Radical Hysterectomy
• Single-site Laparoscopy

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 specific volume of hidden blood loss in patients after the operation applying Gross's formula	10 months after the operation
Secondary	the risk factors of hidden blood loss	Performing multiple linear regression analysis with SPSS 17.0, we plan to identify the risk factors which can increase the volume of hidden blood loss from possible factors like hypertension, diabetes, etc.	10 months after the operation
Secondary	the volume of total blood loss (mL)	the volume of blood loss happened to patients through the whole perioperative period accoring to the method of Nadler	10 months after surgery
Secondary	the volume of visible blood loss (mL)	the volume of visible blood loss including the blood in the suction bottle and in weighed compresses during the operation and the drainage volume as the post-operative blood loss	10 months after surgery