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Published on: April 17, 2019
Diagnostic Accuracy of High-Resolution Manometry for Assessing Fundoplication Integrity: Validation of the Padova
Arianna Vittori1, Giovanni Capovilla1, Matteo Santangelo1
1Department of Surgery, Oncology and Gastroenterology, 1st General Surgery Unit, University of Padua, School of Medicine, Padua, Italy.
Background:
Recurrent symptoms after laparoscopic fundoplication (LF) are not fully understood, with ongoing research focusing on their mechanisms. This study aimed to validate the Padova Classification, a postoperative high-resolution manometry (HRM) framework to distinguish functioning from defective fundoplications.
Methods:
Prospectively collected data from consecutive patients who underwent post-LF HRM (2010-2025) were analyzed and categorized as functioning and effective LF (FELF), post-fundoplication outflow obstruction (PFOO), and ineffective neo-barrier (INB). Primary analysis involved between-group comparisons. Padova Classification diagnostic accuracy was evaluated against a composite reference standard (clinical, radiological, endoscopic, and pH-monitoring criteria) by calculating sensitivity, specificity, positive predictive value, and negative predictive value for each diagnostic category. Diagnostic performance of postoperative integrated relaxation pressure (IRP) for identifying PFOO was evaluated using receiver operating characteristic curve analysis.
Key Results:
Among 373 patients (42.4% female; median age 54 years, median BMI 25.9 kg/m2; 55.2% Nissen, 44.8% Toupet), FELF, INB, and PFOO were observed in 58.7%, 21.4%, and 18.0% of patients, respectively, with PFOO most frequently seen with Nissen fundoplication (p = 0.001). The Padova Classification showed sensitivity/specificity 94.7%/97.1% for FELF, 88.8%/96.9% for INB, and 100%/97.4% for PFOO. Postoperative integrated relaxation pressure accurately discriminated PFOO (AUC 0.959-0.984; cutoff 18.1 mmHg; sensitivity 97.7%-98.0%, specificity 93.2%-96.8%), with no difference between ROC curves derived from Padova Classification and reference standard (p = 0.12).
Conclusions:
This study confirms that the Padova Classification demonstrates strong performance in assessing postoperative LF function.
