A Research on Hidden Blood Loss in Open Radical Hysterectomy and Pelvic Lymphadenectomy

NCT03628118 | Unknown

• 1 other identifier: SAHoWMU-CR2018-07-130
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hidden Blood Loss; Open Radical Hysterectomy; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the risk factors of hidden blood loss

  10 months after surgery

• the volume of total blood loss (mL)

  10 months after surgery

• the volume of visible blood loss (mL)

  10 months after surgery

Study Arms (1)

open radical hysterectomy

The patients who would undergo "open radical hysterectomy" procedure.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The planned sample size was based on data from a previous study, in which the standard deviation was 5. We assumed an one-tailed α error of 0.05 and a sampling error of 1.0. we propose to enroll 105 participants and allow for a dropout rate of 10% for an effective sample size of 100.

You may qualify if:

• Volunteer to participate in the study with informed consent;
• Females aged 20-80 who are confirmed with cervical cancer and are treated with open radical hysterectomy and pelvic lymphadenectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

TING LI

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Qiong ZHANG, Ph.D

CONTACT

13587605820; joan_zhang2002@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 14, 2018
• Study Start: September 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

CN (1)