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

• Conditions: Radical Hysterectomy; Hidden Blood Loss; Single-site Laparoscopy

• Registration Number: NCT03626493
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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 Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Study Start: 2022-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 105

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the volume of hidden blood loss (mL)	10 months after the operation	the specific volume of hidden blood loss in patients after the operation applying Gross's formula

Secondary Outcome Measures

Name	Time	Method
the risk factors of hidden blood loss	10 months after the operation	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.
the volume of total blood loss (mL)	10 months after surgery	the volume of blood loss happened to patients through the whole perioperative period accoring to the method of Nadler
the volume of visible blood loss (mL)	10 months after surgery	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

Trial Locations

Locations (1)

TING LI; 🇨🇳 Wenzhou, Zhejiang, China