Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy

NCT03211481 | Completed

• 1 other identifier: 17-122
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

• blood conservation pathway

  Creation of an intra-operative evidence-informed blood conservation pathway for open myomectomy.

  2 years

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Deborah Robertson, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: June 13, 2017
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)