Hidden Blood LossNCT03626493
A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy
An observational study of Hidden Blood Loss and Single-site Laparoscopy, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Hidden Blood Loss, Single-site Laparoscopy, Radical Hysterectomy
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LSRH | patients who undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the volume of hidden blood loss (mL)
the specific volume of hidden blood loss in patients after the operation applying Gross's formula
Measured: 10 months after the operation
Secondary outcomes (3)
the risk factors of hidden blood loss
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.
Measured: 10 months after the operation
the volume of total blood loss (mL)
the volume of blood loss happened to patients through the whole perioperative period accoring to the method of Nadler
Measured: 10 months after surgery
the volume of visible blood loss (mL)
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
Measured: 10 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidden Blood LossStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626493
- Sponsor's protocol ID
- SAHoWMU-CR2018-07-131
- Status last verified
- Oct 2020
- First submitted
- 6 Aug 2018
- Last updated
- 29 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy
- ClinicalTrials.gov ID
- NCT03626493
- Acronym / sponsor ID
- SAHoWMU-CR2018-07-131
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LSRH | – | –patients who undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
the risk factors of hidden blood loss
Time frame: 10 months after the operation
the volume of total blood loss (mL)
Time frame: 10 months after surgery
the volume of visible blood loss (mL)
Time frame: 10 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidden Blood Loss and Single-site Laparoscopy, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiong ZHANG, Ph.D. (13587605820, joan_zhang2002@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the volume of hidden blood loss (mL) (time frame: 10 months after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.