Abstract

Introduction: Dysphagia is a common adverse event (AE) of anti-reflux surgery, including hiatal hernia repair (HHR) and fundoplication (F). We aimed to determine the frequency, outcomes, and factors associated with the emergence of dysphagia, and need for endoscopy after anti-reflux surgery in patients with hiatal hernia (HH) and gastroesophageal reflux disease (GERD). Methods: We performed a retrospective study across four academic centers between January 2015 and December 2021 in patients with HH and GERD who underwent anti-reflux surgery, either HHR, F, or HHR+F. Kaplan-Meier Estimates with Cox Proportional Hazards Regression Analysis were utilized to determine features associated with the emergence of dysphagia and need for upper endoscopy (EGD) after anti-reflux surgery in patients with HH. Statistical significance was defined as p< 0.10 given the small sample size. Statistical analysis was performed utilizing BlueSky Statistics software v. 7.0. Results: A total of 75 patients were included. (Table) Anti-reflux surgeries included HHR+F (69.3%), HHR (14.7%), or F alone (16.0%). 10.7% of patients had an AE within 30 days. 40.0% developed dysphagia at a median time of 270 days (IQR: 55-907). An EGD was performed in 25 patients (33.3%) with 5 patients having an intervention for dysphagia. Re-do surgery occurred in 10.7% of patients at a median time of 453.0 days (IQR: 349-577). Class II obesity, utilizing mesh for HHR, and using a proton-pump inhibitor prior to surgery were the strongest predictors for developing dysphagia. An HHR+F approached significance for being protective against dysphagia, p=0.1043. Having had a large HH on pre-surgical CT imaging or endoscopic evaluation were strongly associated with the need for EGD after surgery, p=0.0023 and p=0.0263, respectively. Increased blood loss during surgery, younger age, class II obesity, and F alone were also strongly associated with undergoing EGD after surgery at p< 0.05. (Figure) Dyspepsia (40.0%) was the most common indication for EGD. Conclusion: We found dysphagia occurred in 40.0% of patients undergoing anti-reflux surgery. Class II obesity, type of surgery, and a large HH were the strongest predictors for dysphagia and the need for EGD. These characteristics likely have a synergistic effect to increase the risk of AEs after anti-reflux surgery. Further studies on the long-term outcomes of anti-reflux surgery in the management of patients with hiatal hernia are needed.Figure 1.: Kaplan-Meier Estimates of A) Time to Initial Discontinuation of PPI after Anti-Reflux Surgery in Patients with Hiatal Hernia, B) Time to Discontinuation of PPI by Pre-Surgery EGD, and C) Time to Restarting of PPI after Anti-Reflux Surgery by Class II Obesity or Higher (>/= 35.0 kg/m2). Legend A: Blue = BMI >/= 35 kg/m2, Red = BMI < 35 kg/m2; Legend B: Blue = Hiatal Hernia Repair + Fundoplication, Red = Hiatal Hernia Repair or Fundoplication, alone; Legend C: Blue = Fundoplication, alone, Red = Hiatal Hernia Repair +/- Fundoplication. Table 1. - Baseline Characteristics of All Patients and Cox Proportional Hazards Regression for Emergence of Dysphagia and Performance of Upper Endoscopy in Patients with a Hiatal Hernia after Anti-Reflux Surgery Baseline Characteristics Unadjusted Cox Proportional Hazards Regression Median (IQR) or Fraction (%) Dysphagia After Surgery EGD Performed After Surgery All Patients (N=75) HR (95% CI) P value HR (95% CI) P value Age at Surgery, per 10 years 68.7 (59.9-75.2) 0.94 (0.67-1.30) 0.69 0.66 (0.46-0.96) 0.0284 Male 19 (25.3%) 0.77 (0.31-1.89) 0.57 0.84 (0.33-2.14) 0.71 White race 75 (100%) NA NA NA NA Hispanic ethnicity 1 (1.3%) NA NA NA NA Height, per 30 cm 164.0 (158.3-172.8) 1.26 (0.43-3.72) 0.68 1.16 (0.37-3.68) 0.80 Weight, per 10 kg 83.9 (70.7-92.9) 0.94 (0.75-1.17) 0.57 0.96 (0.73-1.25) 0.96 Body Mass Index, per 5 kg/m2 30.8 (27.2-33.6) 1.14 (0.99-1.33) 0.0752 1.22 (1.05-1.41) 0.0113 Body Mass Index ≥ 35 kg/m2 14 (18.7%) 2.60 (1.18-5.72) 0.0172 1.78 (0.73-4.30) 0.20 Obesity 42 (56.0%) 0.78 (0.38-1.61) 0.51 0.98 (0.44-2.17) 0.96 Never Smoker 43 (57.3%) 1.45 (0.69-3.06) 0.33 1.30 (0.58-2.91) 0.53 Moderate to Severe Alcohol Use 16 (21.3%) 0.69 (0.26-1.80) 0.45 1.13 (0.42-3.02) 0.81 Type 2 Diabetes 16 (21.3%) 0.94 (0.40-2.20) 0.88 0.95 (0.37-2.43) 0.95 Interstitial Lung Disease 13 (17.3%) 0.65 (0.23-1.88) 0.43 0.81 (0.29-2.21) 0.68 History of Aspiration 4 (5.3%) 0.56 (0.08-4.10) 0.57 0.66 (0.09-4.91) 0.68 Type of Surgery Hiatal Hernia Repair, alone 11 (14.7%) 1.87 (0.76-4.60) 0.17 0.71 (0.21-2.39) 0.58 Mesh Utilized 17/63 (22.7%) 2.00 (0.89-4.53) 0.0953 1.08 (0.38-3.07) 0.89 Fundoplication, alone 12 (16.0%) 1.44 (0.58) 3.58) 2.78 (1.14-6.77) 0.0241 Nissen 53/64 (70.7%) 0.58 (0.21-1.57) 0.28 1.04 (0.30-3.56) 0.95 Toupet 9/64 (12.0%) 1.67 (0.56-4.95) 0.36 0.70 (0.16-3.02) 0.63 Hiatal Hernia Repair and Fundoplication 52 (69.3%) 0.38 (0.26-1.13) 0.1043 0.60 (0.27-1.34) 0.21 Laparoscopic Approach 71 (94.7%) 0.71 (0.17-2.99) 0.64 1.29 (0.17-9.68) 0.80 Estimated Blood Loss, per 20 mL 20 (10-30) 1.09 (0.97-1.21) 0.14 1.16 (1.02-1.32) 0.0211 Elapsed Time for Surgery, per 30 minutes 142.5 (110.8-174.8) 1.06 (0.78-1.45) 0.70 1.10 (0.75-1.60) 0.62 Time ≥ 180 minutes 11/36 (14.7%) 0.44 (0.09-2.08) 0.30 0.66 (0.17-2.52) 0.54 Pre-Surgical Evaluation EGD prior to surgery 55 (73.3%) 1.12 (0.50-2.51) 0.79 0.96 (0.40-2.31) 0.92 Esophagitis 12/55 (16.0%) 1.53 (0.62-3.76) 0.35 1.34 (0.47-3.76) 0.58 Manometry Performed 32 (42.7%) 0.89 (0.43-1.83) 0.75 0.67 (0.30-1.51) 0.33 Normal Findings 10 (37.0%) 0.66 (0.17-2.55) 0.54 1.67 (0.36-7.77) 0.52 pH Testing Performed 20 (26.7%) 1.21 (0.55-2.66) 0.63 1.34 (0.58-3.13) 0.54 Total Acid Exposure, per 3 % 9.8 (6.0-14.3) 0.96 (0.71-1.29) 0.77 0.75 (0.50-1.13) 0.16 DeMeester Score, per 5 points 32.0 (21.4-51.9) 0.96 (0.83-1.11) 0.59 0.91 (0.76-1.10) 0.33 Large Hiatal Hernia on Endoscopy 28/49 (37.3%) 0.56 (0.24-1.34) 0.19 0.30 (0.11-0.87) 0.0262 Large Hiatal Hernia on CT Imaging 34 (45.3%) 0.61 (0.28-1.30) 0.20 0.19 (0.06-0.55) 0.0023 PPI prior to surgery 62 (82.7%) 3.70 (0.88-15.60) 0.0742 6.24 (0.84-46.3) 0.58 Endpoints Adverse Events within 30 days 8 (10.7%) NA NA NA NA Median Time to Adverse Event, days 21.5 (9.8-25.8) NA NA NA NA Re-do Surgery Performed 8 (10.7%) NA NA NA NA Median Time to Re-do Surgery, days 453.0 (348.5-577.0) NA NA NA NA EGD Performed after Surgery 25 (33.3%) NA NA NA NA Median Time to EGD, days 654.0 (189.0-1244.0) NA NA NA NA Indications for EGD NA NA NA NA Dysphagia 9 (36.0%) NA NA NA NA Abdominal Pain 3 (12.0%) NA NA NA NA Gastrointestinal Bleed 1 (4.0%) NA NA NA NA Dyspepsia 12 (48.0%) NA NA NA NA Occurrence of Dysphagia after Surgery 30 (40.0%) NA NA NA NA Median Time to Dysphagia, days 270.0 (55.0-906.8) NA NA NA NA Median Time to EGD for Dysphagia, days 563.5 (160.8-1228.8) NA NA NA NA Intervention Performed for Dysphagia 5/6 (83.3%) NA NA NA NA Balloon dilation 4 (66.7%) NA NA NA NA Esophageal stent 1 (16.7%) NA NA NA NA

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