Uterine LeiomyomaVALENTINENCT04874246
Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
A study testing Vasopressin in people with Uterine Leiomyoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. Read more about this study
- Who is it for?
- Ages 19 to 60 years, women only
- Conditions the study is for
- Uterine Leiomyoma
- What is being tested?
- Vasopressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2021to 31 Dec 2022
- Phase
- Interventional
- 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 19 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent
- Age: 19-60 year-old women
- Plan of myomectomy for uterine leiomyomas
- Leiomyoma Subclassification System 2-7 (robot-assisted laparoscopic myomectomy is possible)
- American Society of Anesthesiologists Physical Status classification 1 or 2
- A person who understands the contents of the clinical trial, is cooperative with the trial, and is judged to be able to participate until the end of the study
Who cannot join
- Pregnancy or breastfeeding
- A single diameter of uterine leiomyoma is greater than 12 cm or more or multiple leiomyomas with more than five
- Suspicious disease of uterine malignancy
- Patient with has a history of pelvic surgery (cesarean section, myomectomy, etc.) and is expected to have severe pelvic adhesion
- A person who is hypersensitive or contraindicated to vasopressin
- A person who is hypersensitive or contraindicated to tranexamic acid
- Considered as inappropriate by the researcher's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study
The purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.
Read the detailed description
This study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. We would like to evaluate the feasibility and validity of this study for future Phase III randomized clinical trials through this preliminary randomized assignment study.
Uterine fibroids are the most common tumors in women, and uterine myomectomy, which is performed as a treatment for them, is basically a high risk of bleeding and blood transfusion. A common method to reduce intraoperative bleeding is to inject diluted vasopressin into the subserosal areas of the fibroids. However, no proper level of vasopressin dilution has been determined so far, so we want to determine an effective dilution concentration of vasopressin that can minimize side effects through this clinical trial.
- Conditions
- Uterine Leiomyoma
- Being tested
- Vasopressin
- Keywords
- Leiomyoma, Uterine fibroid, Uterine Myomectomy, Hemostasis, Vasopressin, Dilution
- Medical subject headings
- Myofibroma, Leiomyoma, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Also called Vasopressin 20U
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
| Study group | Role | What they receive |
|---|---|---|
| Diluted Vasopressin Group 1 | Active comparator | During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 50 ml of normal saline to make a total of 100 ml) was injected before uterine serosal incision. Receives: Drug: Vasopressin |
| Diluted Vasopressin Group 2 | Active comparator | During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 200 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision. Receives: Drug: Vasopressin |
| Diluted Vasopressin Group 3 | Active comparator | During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 400 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision. Receives: Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss (EBL) during operation
The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle
Measured: during operation
Secondary outcomes (6)
Hemoglobin
Change of serum hemoglobin from baseline
Measured: Post-op 1 day
Hematocrit
Change of serum hematocrit from baseline
Measured: Post-op 1 day
Operation running time
Time from anesthesia start to delivery of patient to recovery room
Measured: during operation
Transfusion
Whether patients are transfused during admission period Number of units transfused red blood cell
Measured: Post-op 2 days
The amount of fluid injected during operation
The amount of fluid injected during operation
Measured: during operation
Hospitalization period
Days from admission day to discharge day
Measured: Within post-op 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start10 May 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine LeiomyomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CHA University
- Responsible party
- Principal investigator, Hee Seung Kim, Seoul National University Hospital
- Investigators
- Hee Seung Kim, MD/PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874246
- Sponsor's protocol ID
- 2011-107-1174
- Acronym
- VALENTINE
- Status last verified
- Jun 2023
- First submitted
- 2 May 2021
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park SJ, Lee JW, Hwang DW, Lee S, Yim GW, Song G, Lee EJ, Kim HS. Effect and Safety of Diluted Vasopressin Injection for Bleeding Control During Robot-assisted Laparoscopic Myomectomy in Reproductive Women With Uterine Fibroids: A Randomized Controlled Pilot Trial (VALENTINE Trial). In Vivo. 2024 Jan-Feb;38(1):431-436. doi: 10.21873/invivo.13456.
PubMed 38148064Lee EJ, Park SJ, Kim Y, Lim H, Lee S, Yim GW, Song G, Kim HS. Effect and safety of diluted vasopressin injection on bleeding during robot-assisted laparoscopic myomectomy: a protocol for a randomised controlled pilot trial. BMJ Open. 2022 Sep 17;12(9):e056145. doi: 10.1136/bmjopen-2021-056145.
PubMed 36115677
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04874246
- Acronym / sponsor ID
- VALENTINE / 2011-107-1174
- Conditions
- Uterine Leiomyoma
- Keywords
- Leiomyoma, Uterine fibroid, Uterine Myomectomy, Hemostasis, Vasopressin, Dilution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- CHA University
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 May 2021 (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 purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.
Detailed description
This study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. We would like to evaluate the feasibility and validity of this study for future Phase III randomized clinical trials through this preliminary randomized assignment study.
Uterine fibroids are the most common tumors in women, and uterine myomectomy, which is performed as a treatment for them, is basically a high risk of bleeding and blood transfusion. A common method to reduce intraoperative bleeding is to inject diluted vasopressin into the subserosal areas of the fibroids. However, no proper level of vasopressin dilution has been determined so far, so we want to determine an effective dilution concentration of vasopressin that can minimize side effects through this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diluted Vasopressin Group 1 | Active comparator | Drug: VasopressinDuring robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 50 ml of normal saline to make a total of 100 ml) was injected before uterine serosal incision. |
| Diluted Vasopressin Group 2 | Active comparator | Drug: VasopressinDuring robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 200 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision. |
| Diluted Vasopressin Group 3 | Active comparator | Drug: VasopressinDuring robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 400 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent
- Age: 19-60 year-old women
- Plan of myomectomy for uterine leiomyomas
- Leiomyoma Subclassification System 2-7 (robot-assisted laparoscopic myomectomy is possible)
- American Society of Anesthesiologists Physical Status classification 1 or 2
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- A single diameter of uterine leiomyoma is greater than 12 cm or more or multiple leiomyomas with more than five
- Suspicious disease of uterine malignancy
- Patient with has a history of pelvic surgery (cesarean section, myomectomy, etc.) and is expected to have severe pelvic adhesion
- A person who is hypersensitive or contraindicated to vasopressin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressinAlso: Vasopressin 20UDuring robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision. | Drug | Diluted Vasopressin Group 1, Diluted Vasopressin Group 2, Diluted Vasopressin Group 3 |
Primary outcome
Estimated blood loss (EBL) during operation
Time frame: during operation
The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle
6 secondary outcomes
Hemoglobin
Time frame: Post-op 1 day
Hematocrit
Time frame: Post-op 1 day
Operation running time
Time frame: during operation
Transfusion
Time frame: Post-op 2 days
The amount of fluid injected during operation
Time frame: during operation
Hospitalization period
Time frame: Within post-op 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 38148064Park SJ, Lee JW, Hwang DW, Lee S, Yim GW, Song G, Lee EJ, Kim HS. Effect and Safety of Diluted Vasopressin Injection for Bleeding Control During Robot-assisted Laparoscopic Myomectomy in Reproductive Women With Uterine Fibroids: A Randomized Controlled Pilot Trial (VALENTINE Trial). In Vivo. 2024 Jan-Feb;38(1):431-436. doi: 10.21873/invivo.13456.
- Derived from this study: PubMed 36115677Lee EJ, Park SJ, Kim Y, Lim H, Lee S, Yim GW, Song G, Kim HS. Effect and safety of diluted vasopressin injection on bleeding during robot-assisted laparoscopic myomectomy: a protocol for a randomised controlled pilot trial. BMJ Open. 2022 Sep 17;12(9):e056145. doi: 10.1136/bmjopen-2021-056145.
- Individual participant dataSharing planned: No
Related trials for Uterine Leiomyoma
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Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
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Renal Tumor Histology, Cutaneous Leiomyoma
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Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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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.
Hee Seung Kim, MD/PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasopressin in people with Uterine Leiomyoma, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jun 2023. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss (EBL) during operation (time frame: during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04874246, which also lists 2 linked publications.
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 26 Jun 2023.