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

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ClinicalTrials.gov Identifier: NCT03626493
Recruitment Status : Not yet recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hidden Blood Loss Laparoendoscopic Single-site Radical Hysterectomy

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.

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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
LSRH
patients who undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626493


Contacts
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Contact: Qiong ZHANG, Ph.D. 13587605820 joan_zhang2002@sina.com

Locations
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China, Zhejiang
TING LI
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
  Study Documents (Full-Text)

Documents provided by Second Affiliated Hospital of Wenzhou Medical University:

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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03626493     History of Changes
Other Study ID Numbers: SAHoWMU-CR2018-07-131
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes