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Study protocol for OtoSurg 1: A prospective evaluation of worldwide tonsillectomy indications, techniques, and
Zachary Elwell1, Emma Finnegan2, Kartik Motwani3
1Department of Otolaryngology-Head and Neck Surgery, University of Arizona College of Medicine - Tucson, Tucson, Arizona, United States of America.
Insights
Tonsillectomy outcomes and risks vary significantly worldwide, especially between high-income and low/middle-income countries. This study aims to quantify these global variations in pediatric tonsillectomy complications and techniques.
Area of Science:
- Global Health
- Pediatric Surgery
- Otolaryngology
Background:
- Tonsillectomy is the most common pediatric surgery globally, but outcomes data are limited.
- Significant risks exist, including a 3% readmission rate in the US and potentially higher mortality in low- and middle-income countries (LMICs).
Purpose of the Study:
- To quantify global variations in 30-day major postoperative complications and mortality following pediatric tonsillectomy across World Health Organization (WHO) regions.
- To characterize global variations in surgical indications and operative techniques for pediatric tonsillectomy across WHO regions.
Main Methods:
- An international, multi-site, prospective cohort study (OtoSurg 1) involving global healthcare facilities performing pediatric tonsillectomy.
- Data collection over a 90-day period on demographics, surgical indications, techniques, complications, and mortality via a de-identified data registry.
- Recruitment of 180 partner sites across six WHO regions.
Main Results:
- Data collection is ongoing; specific results on complication and mortality variations are pending.
- Characterization of surgical indications and techniques across different global regions is underway.
Conclusions:
- This research will identify opportunities to standardize and improve outcomes for pediatric tonsillectomy, particularly in LMICs.
- The study aims to build a sustainable global research network for future large-scale initiatives and data-driven interventions.
Background:
Tonsillectomy is the most common pediatric surgery performed globally, yet little is known about how tonsillectomy outcomes vary worldwide.
Preliminary Data:
Although generally considered a safe surgery, tonsillectomy carries significant risks. Approximately 3% of US children require hospital readmission within 30 days due to life-threatening complications. While mortality rates in high-income countries (HICs) are relatively low (~0.0005%), mortality rates in low- and middle-income countries (LMICs) are not well characterized, with some reports suggesting rates many times higher (~3%).
Research Gap:
Despite the frequency and significance of tonsillectomy, it remains unclear how surgical indications, techniques, and settings may impact outcomes worldwide. In addition, there is currently no mechanism to perform a prospective investigation of global tonsillectomy outcomes.
Hypotheses And Specific Aims:
We hypothesize that the morbidity and mortality of routine tonsil surgery vary significantly according to geographic region and healthcare setting, as well as surgical indications and techniques. We aim 1) to quantify global variation in 30-day major postoperative complications and mortality following pediatric tonsillectomy across World Health Organization (WHO) regions and 2) to characterize global variation in pediatric tonsillectomy surgical indications and operative techniques across WHO regions.
Design:
OtoSurg 1 will be an international, multi-site, prospective cohort study. The central IRB is approved and hosted by Emory University (IRB ID: STUDY00009113). All healthcare facilities globally that perform pediatric tonsillectomy will be invited to participate. Participating investigators will be trained to collect data on patients undergoing primary tonsillectomy over a 90-day period at their respective institutions. Site-based teams will record demographic data, surgical indication(s), surgical technique(s), postoperative complications, and mortality directly into a global de-identified tonsillectomy outcomes data registry. We will leverage existing relationships and professional networks to recruit participants from 30 sites in each of the six WHO regions for a target of 180 partner sites.
Potential Impact:
This study will highlight potential opportunities for intervention to standardize and improve outcomes for the world's most common pediatric surgery, focusing on LMICs. Beyond its primary objectives, this project will also seek 1) to recruit and train a collaborative research network of otolaryngology surgeons from around the world and 2) to build the digital infrastructure necessary to support this network sustainably. This collaborative research network will serve as the foundation for future large-scale research initiatives and for the development and implementation of novel, data-driven interventions.
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