Abstract
Abstract
Background:
Laparoscopic antireflux surgery (LARS) is the gold standard treatment for refractory gastroesophageal reflux disease (GERD). Traditional surgical outcomes following LARS are well described, but limited data exist regarding patient-reported outcomes. We aimed to identify preoperative characteristics that were independently associated with a high GERD health-related quality of life (GERD-HRQL) following LARS.
Methods:
Clinical data from our single institution foregut surgery database were used to identify all patients with GERD who underwent primary LARS from June 2010 to November 2015. Electronic health record data were reviewed to extract patient characteristics, diagnostic study characteristics, and operative data. Postoperative GERD-HRQL data were obtained through telephone follow-up. Variables hypothesized a priori to be associated with high GERD-HRQL after LARS, which were significant at P ≤ .2 on bivariate analysis, were entered into a multivariable linear regression model with GERD-HRQL as the outcome.
Results:
The study included 248 patients; 69.0% were female, 56.9% were married, and 58.1% had concurrent atypical symptoms. The most commonly performed fundoplications were Nissen (44.8%), Toupet (41.3%), and Dor (14.1%), respectively. The median follow-up interval was 3.4 years. The telephone response rate was 60.1%. GERD-HRQL scores improved from 24.8 (SD ±11.4) preoperatively to 3.0 (SD ±5.9) postoperatively. 79.9% of patients were satisfied with their condition at follow-up. On multivariable analysis, being married (P = .04) and absence of depression (P = .02) were independently associated with a higher postoperative QoL.
Conclusions:
Strong social support and psychiatric well-being appear to be important predictors of a higher QoL following LARS. Optimizing social support and treating depression preoperatively and postoperatively may improve QoL outcomes for LARS patients.
Introduction
G
However, the patient characteristics that are associated with an improved QoL after LARS remain unclear. Bell et al. reported that patients who experienced an optimal outcome (defined as a 50% reduction of a GERD-HRQL score) after endoscopic fundoplication (e.g., transoral incisionless fundoplication) were more likely to be older and have a higher preoperative QoL. 13 O'Boyle et al. identified male sex and private health insurance as the strongest predictors of greater satisfaction 5 years after laparoscopic fundoplication. 14 Other studies have identified inconsistent associations between improved postoperative QoL and age, preoperative response to acid suppression medication, baseline symptoms, and baseline esophageal acid exposure. 15
In this study, we analyzed a prospectively maintained institutional foregut database to examine the association between preoperative patient characteristics and postoperative GERD-related QoL. We aimed to identify the extent to which specific patient demographic factors, diagnostic and operative characteristics, were associated with having a high GERD-related QoL after LARS.
Materials and Methods
Data source: UW Foregut Database
All patients who undergo benign foregut surgery within the Division of Minimally Invasive Surgery at the University of Wisconsin Hospital and Clinics (UW) are entered in a prospective patient database. Study data were collected and managed using REDCap (Research Electronic Data Capture), an electronic data capture tool hosted at UW. REDCap is a secure web-based application designed to support data capture for research studies. 16 Data are collected by the administration of preoperative and postoperative questionnaires by clinic staff and by review of the electronic health record (EHR; Epic; Verona, WI) by a database manager. For this study, we included patients with a complaint of “reflux” who underwent primary LARS at UW from June 2010 to November 2015. We excluded reoperative patients and those who underwent a fundoplication for a reason unrelated to reflux (e.g., achalasia).
Preoperative data
During the preoperative visit, patients are given a data collection sheet that includes questions about the primary reason for presentation, GERD-related symptoms, and medications (name, dose, and frequency). Patients report their current condition as satisfied, neutral, or dissatisfied. Three patient-reported health-related QoL scales are included in the data collection sheet. The GERD-HRQL questionnaire evaluates heartburn, dysphagia, and the impact of medication on daily life on a scale from 0 (no symptoms) to 5 (incapacitating symptoms). 17 The Gastroparesis Cardinal Index Scale (GCSI) measures gastroparesis symptoms associated with postprandial fullness, early satiety, bloating, nausea, and vomiting on a severity scale from 0 (none) to 5 (very severe). 18 The total scores on both the GERD-HRQL and GCSI questionnaires range from 0 to 45, with higher scores indicating more severe symptoms. The Eckardt scale evaluates achalasia-type symptoms of dysphagia, regurgitation, chest pain, and weight loss; scores range from 0 to 12 with higher scores indicating more severe symptoms. 19
Patient demographics (age, gender, race, body mass index [BMI], and marital status), comorbidity status, including the presence of depression (determined by whether the patient had an active or past diagnosis of depression, or if the patient was on an antidepressant medication), and preoperative atypical symptoms (chest pain, asthma, chronic cough, or hoarseness) are collected from the EHR by the database manager.
Diagnostic study characteristics include the following: esophagram findings (e.g., presence of a hiatal hernia), esophagogastroduodenoscopy (EGD) results (e.g., presence of esophagitis and histology confirmed Barrett's esophagus), esophageal manometry results (e.g., average distal amplitude), and 24-hour esophageal pH/impedance (e.g., number of reflux events on pH/impedance and percent correlation with patient symptoms). Most patients at our institution do not stop their PPI treatment when undergoing pH/impedance testing and thus Demeester scores were not applicable for most patients.
Operative data
Operative data are extracted from the patient operative note and the EHR. Operative characteristics include the type of procedure (Nissen, Toupet, Dor, and Hiatal Hernia), surgical approach (laparoscopic or open), operative time, use of bougie, mesh use/type, and intraoperative endoscopy.
Postoperative data
Patients who met the inclusion criteria for this study, and underwent LARS at least 9 months before the study inception date, were contacted through telephone and asked to answer a set of questions identical to those included on the preoperative forms.
Statistical analysis
Patient and surgical characteristics were reported as percentages for categorical variables and means, and standard deviation for continuous variables. One patient was missing a GERD-HRQL question from the preoperative questionnaire; to generate a representative score, the answer was imputed by the median value of the answered questions. Bivariate and multivariable general linear regression analyses were used to examine factors predictive of high QoL following LARS. Variables that were significant at a P ≤ .2 on bivariate analysis were entered into a multivariable linear regression model. All independent variables were converted into categorical variables. Age was divided into terciles; BMI was categorized into obese and nonobese patients (BMI cutoff of 30); and number of reflux events was dichotomized at the median (65.0) into lower and higher numbers of reflux events. Preoperative and postoperative GERD-HRQL scores were compared using Wilcoxon signed-rank tests.
Approval from the Health Sciences Institutional Review Board at the University of Wisconsin-Madison was obtained before data collection.
Results
Patient characteristics
The cohort included 248 patients who underwent primary LARS during the study period. Of the 248 patients, 69.0% were female, 56.9% were married, and 95.9% of patients were white (Table 1). The mean age of the study population was 54.5 years (range 20–84). Approximately, one-third (35.5%) of the study population had a preoperative active or past diagnosis of depression. Most patients (87.1%) were taking a PPI preoperatively.
BMI, body mass index; PPI, proton pump inhibitor; SD, standard deviation.
Diagnostic and surgical characteristics
Nearly two thirds (62.5%) of patients had a type 1 hiatal hernia on the preoperative esophagram, and nearly one-third (31.9%) had a type 3 hernia. The presence of esophagitis and Barrett's esophagus was seen in 17.8% and 12.4% of patients, respectively. Patients had a median of 65 reflux events (interquartile range [IQR] 43–106) and a median average distal amplitude of 70 mm Hg (IQR 45–95; Table 2). The most commonly performed fundoplication was a Nissen (44.8%), followed by Toupet (41.3%) and Dor (14.1%). The median operative times were 107, 110, and 131 minutes, respectively. In addition, 79.0% of patients underwent a concurrent laparoscopic hiatal hernia repair.
EGD, esophagogastroduodenoscopy; IQR, interquartile range.
Surgical outcomes
The median follow-up interval was 3.4 years. The telephone response rate for the entire cohort (n = 248) was 60.1%. At follow-up, GERD-HRQL scores improved from 24.8 (±11.4) preoperatively to 3.0 (±5.9) postoperatively. At follow-up, 79.9% of patients reported being satisfied with their condition versus 0% preoperatively, and GERD-HRQL scores improved in all areas of the GERD-HRQL questionnaire (Table 3). The most significant improvements were seen in the questions “how bad is your heartburn” (3.67 to 0.37; P = .0001) and “does having heartburn wake you from your sleep” (3.31 to 0.14; P = .0001).
GERD-HQRL, gastroesophageal reflux disease–health-related quality of life.
Predictors of a higher QoL after LARS
In multivariable linear regression analyses, being married (P = .04) and absence of depression (P = .02) were independently associated with a higher postoperative QoL, while the presence of atypical symptoms, including chest pain, asthma, chronic cough, and hoarseness, was not associated (Table 4). In a sensitivity analysis using a two-way ANOVA model, marital status and depression were independent predictors of a higher postoperative QoL (P = .02 and P = .01, respectively). However, the interaction effect was not significant (P = .34).
BMI, body mass index.
Discussion
We sought to evaluate predictors of higher QoL after LARS in patients with refractory GERD. Consistent with other studies, our findings support the association between LARS with improved QoL.4,5 The vast majority of patients remained satisfied with their surgical outcome more than 3 years after surgery and consistently reported improvement in GERD-related symptoms. We found depression was associated with a worse postoperative QoL, while being married was associated with a better postoperative QoL. Atypical GERD symptoms did not appear to influence GERD-related QoL outcomes in our patient population.
Nearly 8 out of 10 patients were satisfied with their surgical outcome. GERD-HRQL scores improved in all areas addressed in the questionnaire. Our findings add to a significant body of literature suggesting LARS is a durable and effective treatment for GERD.20–23 In a study using the GERD-HRQL questionnaire to assess postoperative QoL, Gee et al. reported that 71% of patients who underwent primary LARS were satisfied at a 5-year follow-up, and 88% stated they would have surgery again. 20 In a study examining long-term durability of LARS, Engstrom et al. reported that postoperative dysphagia and satisfaction scores were stable over a 15-year follow-up period. 21
In our study cohort, the presence of depression was independently associated with worse postoperative QoL. Given that depression is a comorbid condition in 30%–65% of GERD patients, this is an important comorbidity to consider preoperatively. 24 Several studies have examined the impact of depression on LARS outcomes. Power et al. studied 131 patients who underwent laparoscopic Nissen fundoplication and found that preoperative depression and psychogenic stressors were associated with failure after laparoscopic Nissen fundoplication. 25 In this study, failure was characterized by recurrence of symptoms, intractable postoperative dysphagia, or the presence of pronounced short- or long-term adverse sequelae of surgery. Similarly, Kamolz found that GERD patients with depression had significantly higher rates of postoperative chest pain (44.7% vs. 2.6%), bloating (68.4% vs. 18.4%), and dysphagia (50.1% vs. 2.6%) after LARS when compared to patients without depression. 26 In another study of 94 patients undergoing antireflux surgery, only 11% of patients with underlying psychiatric disorders such as major depression or anxiety were satisfied with surgery, compared to 95.3% without psychiatric disorders. 27 The authors concluded that LARS patients with major depression or anxiety disorders demonstrated less symptomatic relief than patients without psychiatric disorders, and should be carefully considered for surgery.
Being married was an independent predictor of higher QoL in our multivariable linear regression analyses. To our knowledge, a positive association between QoL and marriage has not been previously reported in LARS patients. Multiple studies have demonstrated that married patients undergoing cardiac surgery experience improved outcomes, including lower mortality and improved functional capacity.28–30 King and Reis found that married individuals were 2.5 times more likely to be alive 15 years after CABG than those who were not married. 30 Neuman and Werner reported that married patients had a lower risk of developing a new functional disability or dying in the first 2 years after cardiac surgery. 31 Being married has also been associated with improved survival for various types of cancer.28,32,33 Wang et al. reported that married colon cancer patients had a significantly lower risk of death from cancer compared to their unmarried counterparts. 32 The authors posited that married individuals were diagnosed earlier and pursued curative surgical treatment earlier. It is unclear how marriage affected postoperative QoL in our cohort, but surgery earlier in the course of a patient's reflux disease may result in a better outcome.
More than half of the patients in our study reported that, in addition to experiencing typical GERD symptoms, they also experienced atypical symptoms such as chest pain, asthma, chronic cough, and hoarseness. We did not find an association between the presence of atypical symptoms and worse postoperative QoL, which has been reported in other studies. In a cohort of 174 patients who underwent Nissen fundoplication, Morgenthal et al. found that 85% patients with typical symptoms had successful outcomes, compared with only 41% who presented with atypical symptoms. 34 Bresadola et al. reported that patients with atypical symptoms who underwent LARS showed less symptomatic improvement and expressed less satisfaction than patients who presented with typical symptoms. 35 One potential reason for the discordance between our study and others is that our outcome, GERD-HRQL scores, focused entirely on reflux-related symptoms rather than improvements in atypical symptoms, such as coughing or difficulty breathing.
Given that patient-centered outcomes are becoming increasingly important in our current healthcare climate, patient satisfaction and health-related QoL are critical components of a successful surgical outcome. In our foregut registry, we identified depression and marital status as key predictors of postoperative QoL after LARS. Since depression is a potentially modifiable risk factor, our results underscore the importance of screening for depression preoperatively in patients undergoing LARS. Efforts to address and treat depression both preoperatively and postoperatively may help optimize QoL for these patients. Patients with refractory GERD symptoms and psychiatric comorbidities may benefit from a coordinated multidisciplinary approach.
Marital status, while not modifiable, may serve as a marker of social support. Social support can be described as emotionally sustaining qualities of relationships and is increasingly recognized as an important factor in overall and disease-specific quality of life.36–39 Identifying patients with poor social support, and focusing on strategies for increasing patients' social connectedness, may positively impact surgical outcomes. One strategy that has been implemented in other fields, such as cancer care and bariatric surgery, is the establishment of support groups. There may be a role for foregut-specific support groups, both online and in person. Forms of social media, in particular, provide an accessible platform for patients to connect with others suffering from the same disease and an opportunity for physicians to disseminate medically accurate information.
Limitations of this study are important to consider. Since our foregut database was in development during the time period of this study, only 56 of the 248 patients had complete self-reported preoperative disease-specific QoL scales. In addition, some data points are extracted from progress notes in the EHR and may be incorrect or missing if this information was not well documented. For example, the diagnosis of depression and atypical GERD symptoms may not have been identified due to incomplete documentation. Our results, specifically results from the GERD-HRQL, may be confounded by medical therapy in our cohort, as QoL assessments were administered preoperatively and postoperatively, irrespective of whether patients were taking acid-suppressive medications. Our findings may not be generalizable due to differences in the surgical approach. We perform a higher proportion of Toupet and Dor fundoplication compared to other institutions, due to surgeon preferences. However, the impact of the surgical approach on QoL is unclear. In addition, nearly a third of the cohort had a type III paraesophageal hernia, which potentially results in a more heterogeneous pathophysiology and symptom profile for our patient cohort.
In conclusion, identifying predictors of higher QoL after surgery is a priority for surgeons performing LARS. In this study, we utilized our institutional foregut database, with prospectively collected patient-reported outcomes, to evaluate predictors of higher QoL after LARS. Of all patient, diagnostic, and operative characteristics evaluated, depression and being married were significant independent predictors of patients' postoperative QoL. Our results emphasize the importance of patient selection and suggest that some subgroups may require more intensive multidisciplinary care to optimize patient outcomes.
Authors' Contribution
A.K.S., A.M.S., L.M.F., and X.W. contributed to the study design and data collection. All coauthors participated in the data interpretation and revisions. All coauthors approved the version to be published and agree to be accountable for all aspects of the work and ensure that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Footnotes
Disclosure Statement
Drs. Stroud, Greenberg, Shada, Lidor, Wang, and Funk, and Ms. Jolles and Statz declare no conflicts of interest or financial ties to disclose. Effort by Dr. Funk was supported by a VA HSR Career Development Award (15-060). The views expressed are those of the authors and do not necessarily represent those of the Department of Veterans Affairs.
