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Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy: a Modified Delphi Consensus Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT03211481
First received: July 5, 2017
Last updated: NA
Last verified: July 2017
History: No changes posted
  Purpose

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.

We expect that this current study will benefit patients undergoing myomectomy through an improved surgical experience, reduction in blood transfusion rates, and reduction in associated complications.


Condition
Uterine Fibroid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy: a Modified Delphi Consensus Study

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • blood conservation pathway [ Time Frame: 2 years ]
    Creation of an intra-operative evidence-informed blood conservation pathway for open myomectomy.


Estimated Enrollment: 20
Actual Study Start Date: June 13, 2017
Estimated Study Completion Date: June 13, 2019
Estimated Primary Completion Date: June 13, 2019 (Final data collection date for primary outcome measure)
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, we propose the development of 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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211481

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Deborah Robertson, MD St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03211481     History of Changes
Other Study ID Numbers: 17-122
Study First Received: July 5, 2017
Last Updated: July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 11, 2017