Protocol of a multicentre, prospective cohort study that evaluates cost-effectiveness of two perioperative care strategies for potential obstructive sleep apnoea in morbidly obese patients undergoing bariatric surgery

Abstract

IntroductionDespite the high prevalence of obstructive sleep apnoea (OSA) in obese patients undergoing bariatric surgery, OSA is undiagnosed in the majority of patients and thus untreated. While untreated OSA is associated with an increased risk of preoperative and postoperative complications, no evidence-based guidelines on perioperative care for these patients are available. The aim of the POPCORN study (Post-Operative Pulse oximetry without OSA sCreening vs perioperative continuous positive airway pressure (CPAP) treatment following OSA scReeNing by polygraphy (PG)) is to evaluate which perioperative strategy is the most cost-effective for obese patients undergoing bariatric surgery without a history of OSA.Methods and analysisIn this multicentre observational cohort study, data from 1380 patients who will undergo bariatric surgery will be collected. Patients will receive either postoperative care with pulse oximetry monitoring and supplemental oxygen during the first postoperative night, or care that includes preoperative PG and CPAP treatment in case of moderate or severe OSA. Local protocols for perioperative care in each participating hospital will determine into which cohort a patient is placed. The primary outcome is cost-effectiveness, which will be calculated by comparing all healthcare costs with the quality-adjusted life-years (QALYs, calculated using EQ-5D questionnaires). Secondary outcomes are mortality, complications within 30 days after surgery, readmissions, reoperations, length of stay, weight loss, generic quality of life (QOL), OSA-specific QOL, OSA symptoms and CPAP adherence. Patients will receive questionnaires before surgery and 1, 3, 6 and 12 months after surgery to report QALYs and other patient-reported outcomes.Ethics and disseminationApproval from the Medical Research Ethics Committees United was granted in accordance with the Dutch law for Medical Research Involving Human Subjects Act (WMO) (reference number W17.050). Results will be submitted for publication in peer-reviewed journals and presented at (inter)national conferences.Trial registration numberNTR6991.

Evaluation of CPAP adherence in bariatric patients diagnosed with obstructive sleep apnea: outcomes of a multicenter cohort study

“…Patients with no prior history of OSA were eligible for participating in the POPCORN study, a study that evaluates the cost-effectiveness of two different strategies of perioperative management of OSA in patients undergoing bariatric surgery. This study is registered at the Netherlands Trial Register, https://www.trialregister.nl/trial/6805 , and was approved by the Medical Research Ethics Committees United, reference number W17.050 [ 18 ]. The primary outcome of the POPCORN study is cost-effectiveness, and these results are not yet complete.…”

Perioperative management of Obstructive Sleep Apnoea: Present themes and future directions

“…3). The results of the POPCORN study [67] which compares preoperative respiratory polygraphy, and subsequent PAP therapy for newly diagnosed patients, to normal care in patients undergoing bariatric surgery will be of great interest to see the impact of such a pathway.…”

Sleep-Related Breathing Disorder and its Relation to Anesthetic Practice

“…Lack of Standardized Protocols: The lack of standardized protocols for perioperative management of OSA patients can lead to variations in practice. The development and implementation of standardized protocols can ensure consistent and optimal care across different healthcare settings [38] . V. Underdiagnosis and Undertreatment of OSA: Despite its prevalence, OSA remains underdiagnosed and undertreated.…”