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

NCT03626493 | Unknown

• 1 other identifier: SAHoWMU-CR2018-07-131
• 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 undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy and identity its risk factors.

Conditions

Hidden Blood Loss; Single-site Laparoscopy; Radical Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

LSRH

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

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 laparoendoscopic single-site radical hysterectomy with 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

Central Study Contacts

Qiong ZHANG, Ph.D.

CONTACT

13587605820; joan_zhang2002@sina.com

Study Design

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

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 13, 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)