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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: September 1, 2022

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.

Arms, Groups and Cohorts

  • LSRH
    • patients who undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • the risk factors of hidden blood loss
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital of Wenzhou Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Qiong ZHANG, Ph.D., 13587605820, joan_zhang2002@sina.com

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