Uterine FibroidNCT03211481
Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy
An observational study of Uterine Fibroid, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Uterine fibroids are benign uterine masses that can be removed through a surgical procedure called a myomectomy. Myomectomy is often associated with a significant amount of blood loss for the patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uterine Fibroid
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jun 2017to 21 Jun 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The following key stakeholders will be invited to participate in the Delphi process: gynaecologic surgeons, anaesthesiologists, and practitioners who work on blood conservation settings (haematologists, nurses, and pharmacists).
Who may be able to join
- knowledge and experience with fibroid patient population or interventions to reduce major blood loss at surgery
- sufficient time and willingness to participate.
- A member from academic and/or community hospital
Who cannot join
- insufficient knowledge and experience with fibroid patient population or interventions to reduce major blood loss at surgery
- insufficient time or not willing to participate
- Not a member from academic and/or community hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy: a Modified Delphi Consensus Study
Uterine fibroids are benign uterine masses that can be removed through a surgical procedure called a myomectomy. Myomectomy is often associated with a significant amount of blood loss for the patient. The large volume of blood lost can increase post-operative complications and lead patients to require blood replacement (blood transfusion). To reduce the amount of blood lost during the surgical procedure and the need for blood transfusions, interventions such as medications and surgical techniques have been used. While evidence in the literature exists for these techniques, there is no standardized approach to this problem in clinical practice. The objective of this study is to create a novel intra-operative blood conservation pathway, using a modified Delphi expert consensus approach, to decrease the amount of blood lost during myomectomy.
The current study is expected to benefit patients undergoing myomectomy through an improved surgical experience, reduction in blood transfusion rates, and reduction in associated complications.
Read the detailed description
Uterine fibroids are benign uterine masses with a prevalence of 70-80% by age 50 in the population. They can cause heavy menstrual bleeding, pelvic discomfort, and may impair fertility. Surgical removal of uterine fibroids (myomectomy) is commonly offered to women who wish to preserve fertility. Myomectomy is often done through laparotomy (open myomectomy), and is often associated with major surgical blood loss and blood transfusion. A recent Cochrane review of interventions to reduce intra-operative blood loss at myomectomy reported a mean estimated blood loss of 151-1047 mL in the non-intervention group, and a 20% rate of blood transfusion. This rate is particularly alarming in this young female population, as blood transfusion confers immediate and long-term risks, including the development of red blood cell antibodies which may be detrimental in future pregnancy.
Perioperative anemia and intraoperative blood loss have been associated with increased morbidity and mortality. Patients with mild to moderate pre-operative anemia (hemoglobin in the range of 80-120 g/L) have an increased association with severe adverse outcomes. Paradoxically, transfusion of red blood cells has also been associated with increased morbidity and mortality in perioperative patients. Thus, both anemia and one of its primary treatments are associated with adverse outcomes. While these outcomes have not been clearly defined in gynecological surgery, patients facing myomectomy are often severely anemic and can suffer severe blood loss for which red blood cell transfusion is the only therapy. Therefore, any approach that reduces both pre-operative anemia and acute intraoperative blood loss may result in improved patient outcomes.
Clinical pathways to reduce surgical blood loss have demonstrated efficacy in the orthopaedic literature. Successful strategies include avoidance of pre-operative anemia and the intra-operative use of a synthetic antifibrinolytic agent (tranexamic acid), with significant reductions in blood loss and transfusion rates during orthopaedic surgery. Similarly, there is evidence in the gynaecologic literature for interventions to reduce major blood loss and blood transfusion at myomectomy (Table 1), including vaginal misoprostol, vaginal dinoprostone, intramyometrial vasopressin, intravenous tranexamic acid, pericervical tourniquet, and fibrin sealant patch. However, there is currently no standardized intra-operative blood conservation pathway, and clinical practice is variable among clinicians. To address this knowledge translation gap, this study aims to develop an intra-operative pathway designed by a multi-disciplinary team of researchers and end-users to reduce major blood loss and transfusion rates at open myomectomy.
- Conditions
- Uterine Fibroid
- Medical subject headings
- Leiomyoma
What is being measured
The primary outcome is the main question the study is designed to answer.
blood conservation pathway
Creation of an intra-operative evidence-informed blood conservation pathway for open myomectomy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start13 Jun 2017
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Robertson, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211481
- Sponsor's protocol ID
- 17-122
- Status last verified
- Dec 2023
- First submitted
- 5 Jul 2017
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy: a Modified Delphi Consensus Study
- ClinicalTrials.gov ID
- NCT03211481
- Acronym / sponsor ID
- 17-122
- Conditions
- Uterine Fibroid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 7 Jul 2017 (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.
Uterine fibroids are benign uterine masses that can be removed through a surgical procedure called a myomectomy. Myomectomy is often associated with a significant amount of blood loss for the patient. The large volume of blood lost can increase post-operative complications and lead patients to require blood replacement (blood transfusion). To reduce the amount of blood lost during the surgical procedure and the need for blood transfusions, interventions such as medications and surgical techniques have been used. While evidence in the literature exists for these techniques, there is no standardized approach to this problem in clinical practice. The objective of this study is to create a novel intra-operative blood conservation pathway, using a modified Delphi expert consensus approach, to decrease the amount of blood lost during myomectomy.
The current study is expected to benefit patients undergoing myomectomy through an improved surgical experience, reduction in blood transfusion rates, and reduction in associated complications.
Detailed description
Uterine fibroids are benign uterine masses with a prevalence of 70-80% by age 50 in the population. They can cause heavy menstrual bleeding, pelvic discomfort, and may impair fertility. Surgical removal of uterine fibroids (myomectomy) is commonly offered to women who wish to preserve fertility. Myomectomy is often done through laparotomy (open myomectomy), and is often associated with major surgical blood loss and blood transfusion. A recent Cochrane review of interventions to reduce intra-operative blood loss at myomectomy reported a mean estimated blood loss of 151-1047 mL in the non-intervention group, and a 20% rate of blood transfusion. This rate is particularly alarming in this young female population, as blood transfusion confers immediate and long-term risks, including the development of red blood cell antibodies which may be detrimental in future pregnancy.
Perioperative anemia and intraoperative blood loss have been associated with increased morbidity and mortality. Patients with mild to moderate pre-operative anemia (hemoglobin in the range of 80-120 g/L) have an increased association with severe adverse outcomes. Paradoxically, transfusion of red blood cells has also been associated with increased morbidity and mortality in perioperative patients. Thus, both anemia and one of its primary treatments are associated with adverse outcomes. While these outcomes have not been clearly defined in gynecological surgery, patients facing myomectomy are often severely anemic and can suffer severe blood loss for which red blood cell transfusion is the only therapy. Therefore, any approach that reduces both pre-operative anemia and acute intraoperative blood loss may result in improved patient outcomes.
Clinical pathways to reduce surgical blood loss have demonstrated efficacy in the orthopaedic literature. Successful strategies include avoidance of pre-operative anemia and the intra-operative use of a synthetic antifibrinolytic agent (tranexamic acid), with significant reductions in blood loss and transfusion rates during orthopaedic surgery. Similarly, there is evidence in the gynaecologic literature for interventions to reduce major blood loss and blood transfusion at myomectomy (Table 1), including vaginal misoprostol, vaginal dinoprostone, intramyometrial vasopressin, intravenous tranexamic acid, pericervical tourniquet, and fibrin sealant patch. However, there is currently no standardized intra-operative blood conservation pathway, and clinical practice is variable among clinicians. To address this knowledge translation gap, this study aims to develop an intra-operative pathway designed by a multi-disciplinary team of researchers and end-users to reduce major blood loss and transfusion rates at open myomectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The following key stakeholders will be invited to participate in the Delphi process: gynaecologic surgeons, anaesthesiologists, and practitioners who work on blood conservation settings (haematologists, nurses, and pharmacists).
Key inclusion criteria (3 listed)
- knowledge and experience with fibroid patient population or interventions to reduce major blood loss at surgery
- sufficient time and willingness to participate.
- A member from academic and/or community hospital
Key exclusion criteria (3 listed)
- insufficient knowledge and experience with fibroid patient population or interventions to reduce major blood loss at surgery
- insufficient time or not willing to participate
- Not a member from academic and/or community hospital
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
blood conservation pathway
Time frame: 2 years
Creation of an intra-operative evidence-informed blood conservation pathway for open myomectomy.
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 13 Dec 2023.
- Individual participant dataSharing planned: No
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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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.
Deborah Robertson, MD principal investigator
Unity Health Toronto
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 Uterine Fibroid, run by Unity Health Toronto at 1 site in Canada.
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 3 inclusion and 3 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 13 Dec 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 Canada. 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?
blood conservation pathway (time frame: 2 years). 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 13 Dec 2023.