Abstract
Introduction: Laparoscopic fundoplication is the gold standard treatment for gastroesophageal reflux disease (GERD) refractory to medical management. Although many studies have compared Nissen fundoplication (NF) to Toupet fundoplication (TF), it is unclear which operation provides the best long-term reflux control. The objective of this study was to evaluate long-term quality-of-life (QoL) outcomes after NF versus TF.
Methods: Clinical data from our single academic institutional foregut database were used to identify patients who underwent NF or TF (June 2010 to May 2016). Postoperative QoL was assessed through telephone at 1, 3, or 5 years postsurgery, using GERD-health related quality of life (GERD-HRQL), Gastroparesis Cardinal Symptom Index (GCSI), and Eckardt Dysphagia scores. Proton pump inhibitor (PPI) use and satisfaction with surgery were also obtained. Trends in outcomes over time were analyzed by logistic regression or Cochran-Armitage trend test.
Results: Our cohort included 155 TF and 161 NF patients. TF patients reported baseline dysphagia at higher rates (42.6% versus 19.9%; P < .001) and had worse preoperative esophageal dysmotility than NF patients. There were no significant differences in GERD-HRQL or GCSI scores between TF and NF patients at any time point postoperatively. Long-term satisfaction was equivalent between TF and NF patients 5 years postoperatively (70.0% versus 77.4%; P = .67). NF patients had higher Eckardt dysphagia scores 1 year after surgery compared to TF patients, but this difference was not present at 3 or 5 years postoperatively. Over time, PPI use increased and there was a trend toward increased GERD-HRQL scores in the TF group.
Conclusions: Both TF and NF provide excellent long-term satisfaction for patients with GERD. NF and TF patients reported similar postoperative QoL scores. Our finding of increasing PPI use and a trend toward worsening GERD scores following TF warrants additional investigation regarding the long-term durability of TF.
Keywords: : GERD, laparoscopic Nissen fundoplication, laparoscopic Toupet fundoplication, quality of life, long-term outcomes
Introduction
Gastroesophageal reflux disease (GERD) is among the most common foregut disorders, with an estimated prevalence of 20%–40% among adults.1–3 The prevalence of GERD and its associated resource utilization have increased over time, with GERD-related ambulatory care visits nearly doubling between 1995 and 2006.4 Traditional medical management has involved lifestyle modification and indefinite proton pump inhibitor (PPI) therapy. However, up to 20%–30% of patients do not achieve adequate symptom relief on this regimen.5 These patients refractory to medical management are candidates for antireflux surgery, which has repeatedly been demonstrated to be an effective treatment strategy.6–8
Since the early 1990s, the surgical mainstay for the treatment of GERD has been laparoscopic fundoplication. The most frequently performed fundoplication is the laparoscopic Nissen fundoplication (NF), or a 360° posterior fundoplication. Long-term success of this operation is well documented, with up to 75% of patients symptom free at 20 years, and 90% of patients satisfied with their choice of surgery.9 However, due to the frequency of postfundoplication symptoms, including dysphagia and gas-related complaints, some surgeons have proposed partial fundoplication as an alternative.10,11 One such variation is the laparoscopic Toupet fundoplication (TF), which involves a 270° posterior fundoplication.12,13 Since its development, however, some in the surgical community have questioned long-term durability of TF.14,15 Multiple prospective randomized trials have compared NF and TF, and several meta-analyses of their results have found equivalent results in terms of disease resolution and patient satisfaction, but increased rates of dysphagia and gas bloat among patients undergoing NF.16,17 However, few of these studies report outcomes beyond 1 or 2 years of follow-up.
Due to the lack of long-term data comparing NF and TF, and a particular paucity of quality-of-life outcomes, we analyzed our prospectively maintained institutional foregut database to compare patient-reported outcomes at 1, 3, and 5 years following laparoscopic fundoplication.
Materials and Methods
Data source: University of Wisconsin Hospital and Clinics Foregut Database
The Division of Minimally Invasive Surgery at the University of Wisconsin Hospital and Clinics (UW) maintains a patient database, which includes all patients who undergo benign foregut surgery. Study data are collected and managed using REDCap (Research Electronic Data Capture), a secure web-based data capture tool hosted at UW. Data are collected by administration of preoperative and postoperative questionnaires by clinic staff and review of the electronic medical record by a database manager.
For this study, we included all patients who underwent laparoscopic NF or laparoscopic TF for gastroesophageal reflux between June 2010 and May 2016. We excluded patients who had a preoperative diagnosis of achalasia or underwent a concurrent Heller myotomy.
Preoperative data
Baseline demographic information included sex, age, and body mass index (BMI). The primary presenting complaints related to GERD were recorded. Data regarding preoperative workup included whether they received a barium esophagram, esophagogastroduodenoscopy (EGD), 24-hour pH/impedance testing, and high-resolution esophageal manometry. For those patients who had test results available, we collected whether a hiatal hernia was detected on barium esophagram; whether esophagitis or Barrett's were detected on EGD; and the mean distal wave amplitude, percent of failed esophageal contractions, and percent of simultaneous contractions on manometry. Many patients cared for at our institution do not stop their PPI therapy when undergoing pH/impedance testing, precluding the routine calculation of DeMeester scores. Instead, the total number of reflux episodes in the 24-hour period was recorded.
Operative data
The type of fundoplication, Nissen or Toupet, was recorded. The year in which surgery was performed, whether it was a reoperative fundoplication, and the operating duration were collected.
Postoperative data
Patients in the database who met inclusion criteria were contacted by phone to provide data regarding their quality of life following fundoplication. Depending on the date of their surgery, they were placed into one of three study cohorts: 1-, 3-, or 5-year follow-up, depending on whether their operation was performed between February 11, 2015 and May 10, 2016; July 27, 2012 and January 9, 2015; and June 11, 2010 and July 26, 2012, respectively.
Three validated patient-reported quality-of-life measures were used to evaluate GERD symptoms and outcomes. The GERD-health related quality of life (GERD-HRQL) questionnaire evaluates heartburn, dysphagia, and the impact of antireflux medication on daily life on a scale from 0 (no symptoms) to 5 (incapacitating symptoms).18 The Gastroparesis Cardinal Symptom Index (GCSI) evaluates postprandial fullness, early satiety, bloating, nausea, and vomiting on a severity scale from 0 (none) to 5 (very severe).19 Both the GERD-HRQL and the GCSI have total scores ranging from 0 to 45, with higher scores indicating more severe symptoms. The Eckardt scale evaluates dysphagia, regurgitation, chest pain, and weight loss; total scores range from 0 to 12, with higher scores indicating more severe symptoms.20
At their follow-up phone call, patients were also asked whether they were taking a PPI for their GERD symptoms. Patient satisfaction with their index operation was measured on a 3-point Likert scale (satisfied, neutral, and dissatisfied).
Statistical analysis
Categorical variables were reported as percentages; continuous variables were reported as means and standard deviations. Baseline characteristics were compared between procedure groups at baseline for all patients and for each of the interval cohorts. Postoperative quality-of-life measures were compared between procedure groups for each follow-up cohort. Bivariate analyses were performed comparing patients who underwent NF versus TF, with t-tests or Wilcoxon-Mann-Whitney tests for continuous variables and chi-square or Fisher's exact test for categorical variables.
A linear regression model was used to test whether a linear trend occurred for GERD-HRQL, GCSI, and Eckardt scores over time. The trend in the use of PPI and satisfaction with surgery were examined using Cochran-Armitage trend tests. We established a significance cutoff of P = .05 for all tests.
Results
Patient characteristics
Three hundred sixteen patients met the inclusion criteria and were included in the analysis. Of these, 155 (49.1%) underwent TF and 161 (50.9%) underwent NF (Table 1). At baseline, patients in the TF group were older (56.6 ± 14.6 versus 51.6 ± 13.8 years, respectively; P = .002) and more likely to be female (70.3% versus 57.1%, respectively; P = .01) than the NF group. The two groups had similar rates of reoperative fundoplication. Patients who received TF were more likely to present with a primary complaint of dysphagia than those who received NF (42.6% versus 19.9%, respectively; P < .001); they were equally likely to report reflux or chest pain as their primary complaint.
Table 1.
Baseline Characteristics of All Included Patients
| Toupet (n = 155) | Nissen (n = 161) | P | |
|---|---|---|---|
| Demographics | |||
| Female, n (%) | 109 (70.3) | 92 (57.1) | .01 |
| Age, mean ± SD | 56.6 ± 14.6 | 51.6 ± 13.8 | .002 |
| BMI, mean ± SD | 30.02 ± 5.43 | 29.98 ± 4.97 | .95 |
| Reoperative fundoplication, n (%) | 34 (21.9) | 25 (15.5) | .14 |
| Presenting complaints, n (%) | |||
| Reflux | 137 (88.4) | 144 (89.4) | .77 |
| Pain | 34 (21.9) | 37 (23.0) | .82 |
| Dysphagia | 66 (42.6) | 32 (19.9) | <.001 |
| Preoperative workup | |||
| Hiatal hernia seen on barium esophagram, n (%)a | 79 (66.4) | 74 (69.8) | .58 |
| EGDb | |||
| Barrett's esophagus, n (%) | 21 (14.3) | 17 (11.4) | .46 |
| Esophagitis, n (%) | 29 (20.6) | 30 (19.9) | .88 |
| No. of reflux episodes, mean ± SDc | 83.3 ± 44.6 | 73.8 ± 50.1 | .12 |
| Manometryd | |||
| Max amplitude, mean ± SD | 68.1 ± 39.1 | 86.0 ± 40.0 | <.001 |
| % failed contractions, mean ± SD | 20.9 ± 27.0 | 10.9 ± 23.0 | .009 |
| % simultaneous contractions, mean ± SD | 10.5 ± 22.4 | 2.2 ± 8.6 | .08 |
| Follow-up cohort, n (%)e | <.001 | ||
| 1-year follow-up (February 11, 2015–May 10, 2016) | 61 (39.4) | 35 (21.7) | |
| 3-year follow-up (July 27, 2012–January 9, 2015) | 79 (51.0) | 44 (27.3) | |
| 5-year follow-up (June 11, 2010–July 26, 2012) | 12 (7.7) | 82 (50.9) | |
| Duration of surgery (minutes), mean ± SD | 126.6 ± 42.1 | 118.8 ± 39.3 | .09 |
122 (78.7%) patients in the Toupet group and 108 (67.1%) patients in the Nissen group underwent barium esophagram.
148 (95.5%) patients in the Toupet group and 151 (93.8%) patients in the Nissen group underwent EGD.
80 (52.0%) patients in the Toupet group and 87 (54.0%) patients in the Nissen group underwent impendence testing.
97 (63.0%) patients in the Toupet group and 97 (60.6%) patients in the Nissen group underwent manometry.
Three patients in the Toupet group fell in the interval between 1-year follow-up and 3-year follow-up, leading to the discrepancy between number of patients eligible for follow-up and the total N among Toupet patients.
BMI, body mass index; EGD, esophagogastroduodenoscopy; SD, standard deviation.
Diagnostic and operative characteristics
There were similar rates of hiatal hernia detected on barium esophagram and similar rates of esophagitis and Barrett's esophagus on EGD between the NF and TF groups (Table 1). On impedance testing, both groups had similar numbers of reflux episodes. On manometry, TF patients had lower mean distal esophageal amplitude (68.1 ± 39.1 versus 86.0 ± 40.0, respectively; P < .001), a greater average percent of failed esophageal contractions (20.9 ± 27.0 versus 10.9 ± 23.0, respectively; P = .009), and a greater average percent of simultaneous esophageal contractions (10.5 ± 22.4 versus 2.2 ± 8.6, respectively; P = .08), indicating greater baseline esophageal dysmotility among TF patients than among NF patients.
NF tended to be performed earlier in the study period, while TF was performed at higher rates later in the study period (Table 1). The average operative time was not statistically different between the two groups (126.6 ± 42.1 versus 118.8 ± 39.3 minutes; P = .09).
The follow-up cohorts reflected the overall study population in their baseline characteristics, and there were no significant differences between procedure groups in any of the follow-up cohorts, other than those mentioned above (Supplementary Tables S1–S3; Supplementary Data are available online at www.liebertpub.com/lap).
Response rates
Among patients who had 1 year of follow-up, 62.3% of patients in the TF group and 65.7% of patient in the NF group responded to the telephone survey (P = .74). In the cohort of patients with 3 years of follow-up, 59.5% of patients in the TF group and 54.6% of patients in the NF group responded to the telephone survey (P = .59). In the 5-year follow-up cohort, 83.3% of patients in the TF group and 64.6% of patients in the NF group responded to the telephone survey (P = .33) (Table 2).
Table 2.
Response Rates for Each Follow-Up Study Cohort
| Toupet | Nissen | ||||
|---|---|---|---|---|---|
| Eligible, n | Responded, n (%) | Eligible, n | Responded, n (%) | P | |
| 1 year | 61 | 38 (62.3) | 35 | 23 (65.7) | .74 |
| 3 years | 79 | 47 (59.5) | 44 | 24 (54.6) | .59 |
| 5 years | 12 | 10 (83.3) | 82 | 53 (64.6) | .33 |
Quality of life outcomes
There were no significant differences in the GERD-HRQL or GCSI scores between the TF and NF groups at any time point (Table 3). There was a trend toward worsening GERD-HRQL scores over time in the TF group (P = .07), which was not present in the NF group. At 1 year, the Eckardt dysphagia scores were significantly elevated in the NF group compared to the TF group (2.35 ± 1.58 versus 1.61 ± 1.98, respectively; P = .03), but this difference dissipated over time, with no significant difference at the 3- and 5-year time points (P = .75 and .74, respectively).
Table 3.
Quality-of-Life Outcomes, Proton Pump Inhibitor Use, and Satisfaction by Procedure Type for Each of the Follow-Up Study Cohorts
| 1 year | 3 years | 5 years | Trend analysis P value | |
|---|---|---|---|---|
| GERD-HRQL (mean ± SD) | ||||
| Toupet | 2.45 ± 4.08 | 3.57 ± 6.16 | 5.60 ± 5.83 | .07 |
| Nissen | 3.48 ± 5.29 | 2.42 ± 6.10 | 2.79 ± 6.44 | .69 |
| Between-procedure P value | .46 | .31 | .11 | |
| GCSI (mean ± SD) | ||||
| Toupet | 5.03 ± 6.60 | 7.70 ± 8.54 | 4.90 ± 4.48 | .37 |
| Nissen | 5.30 ± 4.91 | 5.50 ± 6.49 | 5.94 ± 7.51 | .62 |
| Between-procedure P value | .41 | .48 | .87 | |
| Eckardt (mean ± SD) | ||||
| Toupet | 1.61 ± 1.98 | 1.55 ± 1.63 | 1.30 ± 0.95 | .88 |
| Nissen | 2.35 ± 1.58 | 1.71 ± 1.76 | 1.45 ± 1.68 | .08 |
| Between-procedure P value | .03 | .75 | .74 | |
| PPI Use (%) | ||||
| Toupet | 15.8 | 59.6 | 70.0 | <.001 |
| Nissen | 27.3 | 41.7 | 37.7 | .48 |
| Between-procedure P value | .28 | .15 | .09 | |
| Satisfaction (%) | ||||
| Toupet | 86.8 | 74.5 | 70.0 | .13 |
| Nissen | 87.0 | 79.2 | 77.4 | .36 |
| Between-procedure P value | 1.00 | .77 | .67 | |
GCSI, Gastroparesis Cardinal Symptom Index; GERD-HRQL, gastroesophageal reflux disease healthcare-related quality of life; PPI, proton pump inhibitor.
There was a significant increase in the percentage of patients in the TF group taking a PPI over time, with 70.0% of patients taking a PPI 5 years after surgery versus 15.8% at 1 year after surgery (P < .001) (Table 3). There was no significant increase in PPI use over time in the NF group (P = .48). There was a trend toward increased PPI use in the TF group compared to the NF group at 5 years, although this did not reach statistical significance (70.0% versus 37.7%, respectively; P = .09).
Patient satisfaction was universally high, with no significant difference at any time point between the two groups (Table 3). At 1 year of follow-up, 86.8% of patients in the TF group and 87.0% of patients in the NF group reported being satisfied with their surgery (P = 1.00). At 3 years of follow-up, 74.5% of patients in the TF group and 79.2% of patients in the NF group reported being satisfied with their surgery (P = .77). At the 5-year follow-up survey, 70.0% of patients in the TF group and 77.4% of patients in the NF group reported being satisfied with their surgery (P = .67). There were no significant differences in satisfaction rates in either the TF or NF groups on trend analysis over time (P = .13 and .36, respectively).
Discussion
In this study, we sought to evaluate the long-term impact on quality of life in patients undergoing laparoscopic NF or TF. We found equivalent outcomes in measures of GERD and gastroparesis symptoms between the two procedures, but an increased rate of postoperative dysphagia at 1 year in the NF patients that dissipated over time. There was an increasing use of PPI and a trend toward worse GERD-HRQL scores over time in the TF group, which was not seen in the NF group. Overall, there was high satisfaction in both procedure groups at each time point.
At baseline, patients undergoing TF had higher rates of dysphagia and worse esophageal motility on preoperative manometry. This is not surprising, given that concerns over postoperative dysphagia following NF have led many surgeons to recommend TF for patients who have preexisting dysphagia and esophageal dysmotility.21 Indeed, it was a motivating factor for the increased adoption of TF at our institution over the study period, for patients with and without baseline esophageal dysmotility. Despite this, patients undergoing TF had less dysphagia, particularly in the short term, when compared to patients undergoing NF.
We found no significant differences in the GERD-HRQL or GCSI scores between the TF and NF patients at any time point. There was a trend toward worsening GERD-HRQL scores over time in the TF group, although this did not reach statistical significance. These results are similar to previous studies demonstrating equivalent symptom management between TF and NF, including several randomized trials. Kamolz et al. found no difference in postoperative quality-of-life scores between patients undergoing TF or NF, with both groups seeing improvements in their scores to a level comparable to healthy controls.22
While GERD and gastroparesis scores were similar between TF and NF patients, we did find a significant difference in short-term postoperative dysphagia. NF patients had higher rates of dysphagia in the early postoperative period, but this improved with time and was not significantly different than their TF counterparts at 3 or 5 years postoperatively. This suggests that postoperative dysphagia is not a permanent effect of surgery. In a randomized trial comparing NF and TF, Chrysos et al. reported a higher percentage of patients who underwent NF reporting dysphagia at 3 months postoperatively compared to patients who underwent TF (57% versus 16%, respectively; P < .01), but that this difference disappeared at 12 months postoperatively.23 In a similar study, Guérin et al. reported no significant difference in postoperative dysphagia between patients undergoing TF or NF at 1 or 3 years postoperatively.24 Unlike these studies, Strate et al. reported a greater than two-fold increase in the rate of postoperative dysphagia following NF compared to TF with 2 years of follow-up in their randomized trial (19% versus 8%, respectively; P < .05).25 However, the results of this study and those like it suggest that while postoperative dysphagia after NF may be more common than after TF in the short term, it often resolves with time.
We report a statistically significant increase in PPI use over time in patients who underwent TF, which was not seen in patients who underwent NF, whose PPI use remained low at every follow-up time point. This increase in PPI use along with the trend in worsening GERD-HRQL in TF patients over time suggests that TF may have limited long-term durability. Few studies comparing TF and NF have compared postoperative PPI use and none report long-term quality-of-life outcomes. However, Shaw et al. showed no statistically significant difference in postoperative PPI use in their randomized trial comparing TF and NF (P = .55), with an average of over 5 years of follow-up.26
Overall satisfaction was high at all follow-up time points and was not statistically different between NF and TF patients. High satisfaction after fundoplication has been reported in numerous previous studies, regardless of operative approach or technique. Meta-analyses of randomized studies comparing NF and TF have reported equivalent satisfaction between the two procedures.16,17 In a study of long-term outcomes following NF with a median follow-up of 19 years, Sadowitz et al. reported a satisfaction rate of 88%, with 95% saying they would have the operation again.27 Shaw et al. reported equivalent long-term satisfaction at an average of nearly 5 years after surgery, with 91.9% of NF patients and 91.6% of TF patients believing they were better off than before surgery (P = 1.0), and 86.5% of NF patients and 83.3% of TF patients saying they would have surgery again (P = 1.0).26 This suggests that reported differences in dysphagia, GERD symptoms, and PPI use between the two procedures are not significant enough to impact overall satisfaction and patients remain highly satisfied regardless of procedure.
While quality-of-life measures and patient-reported outcomes are important to follow and report, they may not accurately represent objective measures of GERD remission or recurrence, which we do not report in this study. In a study examining the accuracy of symptomatic assessment compared to DeMeester scores in patients who had undergone fundoplication, Khajanchee et al. found that symptomatic assessment had a sensitivity of 48% and a specificity of 77% at detecting GERD recurrence.28 Thus, determinations of success following fundoplication using patient-reported symptoms alone should be evaluated with caution.
The results of this study should be interpreted in light of its limitations. It is a single-institution retrospective study with a relatively small sample size. Our institution performs a higher proportion of TF than other institutions, due to surgeon preference, and this has increased over time. This led to a smaller number of patients in the TF group eligible for long-term follow-up, and could account for the lack of statistical significance in some of the comparison between follow-up cohorts and procedure groups. In addition, there are significant differences in baseline presentation between the two procedure groups, most notably with the patients in the TF group having more dysphagia and esophageal dysmotility. However, despite their increased rate of baseline dysphagia, they reported less dysphagia in the 1-year follow-up cohort, which supports the conclusion that NF causes higher rates of early postoperative dysphagia than TF. Finally, PPI use is likely an insufficient marker of GERD recurrence in this study, as we do not have access to the indication for their use. We do not know if the observed increase in PPI use among TF patients represented GERD recurrence in those patients.
In conclusion, we have found that quality-of-life outcomes for patients undergoing NF and TF are equivalent at 1, 3, and 5 years postoperatively. NF may cause greater short-term dysphagia than TF, but this resolved with time. Patients have high satisfaction with their chosen operation, which persists to 5 years following surgery. Our data suggest that TF may have limited long-term durability, given increasing PPI use and a trend toward worsening GERD-HRQL scores over time, although further studies are needed to corroborate our findings.
Authors' Contributions
A.L.S., A.O.L., 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 to ensure that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Supplementary Material
Disclosure Statement
No competing financial interests exist.
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