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Design and Early Experience With a Real-World Surgical Registry

Weber LeBrun, Emily E., MD, MS; Lynch, Lauren D., BS; Peterson, Hanna V., BS; Pena, Savannah Rose, BS; Ruder, Kara, BS; Vasilopoulos, Terrie, PhD

Female Pelvic Medicine & Reconstructive Surgery: September/October 2018 - Volume 24 - Issue 5 - p 341–346
doi: 10.1097/SPV.0000000000000453
Original Articles

Objectives We describe the rationale, design, and methods and 6-year experience with a real-world surgical registry for female pelvic reconstructive and incontinence procedures and postoperative outcomes.

Methods The primary goal of creating this registry was to establish the feasibility of prospective data capture for all urogynecologic procedures. Data captured included baseline demographics, surgical procedures, perioperative complications, and subjective and objective findings up to 36 months after surgery.

Results The Pelvic Reconstruction and Incontinence Surgery ± Mesh Registry was developed over 3 years to include 194 unique variables for prospective data capture. The registry was implemented in December 2010, and data from 924 separate case events from a single surgeon were recorded, comprising 100% surgical case capture. Cases included a variety of procedures representing a comprehensive urogynecology practice on 804 unique patients. Patients who were asked to participate in long-term follow-up (n = 299) returned with attendance of 96% at 6 weeks, 64% at 6 months, 51% at 12 months, 39% at 24 months, and 22% at 36 months.

Conclusions The Pelvic Reconstruction and Incontinence Surgery ± Mesh Registry effectively captured all urogynecologic procedures for the purpose of quality improvement. This real-world tool demonstrates that 100% case capture is feasible and provides valuable information for the highly motivated surgeon, although adequate long-term follow-up is limited. Additional research is needed to better understand the role of surgical registries for quality improvement and development of patient-centered strategies to increase long-term follow-up.

From the University of Florida College of Medicine, Gainesville, FL.

Correspondence: Emily E. Weber LeBrun, MD, MS, 1600 SW Archer Rd, PO Box 100294, Gainesville, FL 32610. E-mail: eweber@ufl.edu.

The authors have declared they have no conflicts of interest.

The development of the Pelvic Reconstruction and Incontinence Surgery ± Mesh Registry was supported by an unrestricted grant facilitated by the Food and Drug Administration Division of Postmarket Surveillance in 2008 (subcontract SES-FDA03-S-08-00151).

The findings included in this article were presented at the 43rd Annual Meeting of the Society of Gynecologic Surgeons, March 26 to 29, 2017, in San Antonio, TX.

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