Quality of life after Nissen fundoplication in patients with gastroesophageal reflux disease

Comparison between long- and short-term follow-up

Abstract

Introduction: 

Nissen fundoplication is the golden standard for surgical treatment of gastroesophageal reflux disease (GERD). Numerous studies report excellent short-term results. However, data regarding long-term quality of life are lacking. The aim of this study is to investigate the long-term quality of life after Nissen fundoplication in patients with GERD and to compare this with the short-term results.

Patients and Methods: 

We retrospectively analysed all patients who underwent laparoscopic Nissen fundoplication for GERD between January 2004 and January 2016. All patients received a validated GERD-Health-Related Quality of Life questionnaire by mail to assess post-operative quality of life. Maximum quality of life is represented by a score of 75. Secondary outcome measures were complications and recurrence rate.

Results: 

One hundred and seventy-five (77.1%) of the 227 operated patients returned the questionnaire. The median follow-up was 3.7 (0.1–10.3) years. Mean age was 51.6 (range 15–85) and 72 patients were male. We report an excellent quality of life with a median total score of 70 (range 2–75). Re-operation rate was 13.6% (23/169); the re-operation was due to recurrent reflux in 12 patients and due to persistent dysphagia in 11 patients. 91.3% of the re-operations were performed within the first 5 years after surgery. Mortality rate was zero.

Conclusion: 

We report a large series of single-centre, single-surgeon laparoscopic Nissen fundoplication. Despite the re-operation rate of 13.6%, we found excellent long-term symptomatic outcome. There was no difference between short- and long-term results.

INTRODUCTION

Laparoscopic antireflux surgery (LARS) is considered the golden standard in the surgical treatment of gastroesophageal reflux disease (GERD).[¹²] Since Cuschieri et al. performed the first laparoscopic Nissen fundoplication in 1992, this procedure gained increasing popularity over time.[³] Many studies report good results after Nissen fundoplication with a successful symptomatic outcome in 80%–95% of the patients at a long-term follow-up of up of 5 years.[⁴⁵⁶⁷] Despite the good symptomatic results, there are still many patients who report recurrent reflux or new symptoms that were not present before surgery. This may negatively influence the quality of life.

The GERD-Health-Related Quality of Life (GERD-HRQL) is a validated instrument to measure the quality of life after LARS for patients with GERD.[⁸⁹] The questionnaire assesses most common symptoms and their impact on daily life. Many studies report symptomatic outcome after Nissen fundoplication. However, very few studies report on the long-term quality of life. Therefore, the aim of this study is to report on the quality of life after Nissen fundoplication at a long-term follow-up of up to 10.3 years. We compared the long-term results with the short-term outcome. This is a single-centre, single-surgeon study.

PATIENTS AND METHODS

For this study, we included patients who underwent antireflux surgery for GERD. Initially, the patients were diagnosed by 24-h pH-meter of endoscopy with proven oesophagitis. Since the introduction of the SAGES guideline for GERD in 2010, patients were diagnosed according this guideline.[²] All data were retrieved from the hospital information system, for patients who were operated at our institution between 1^st January 2004 and 1^st January 2016. Parameters that were extracted included patient characteristics, pre-operative symptoms, medication usage, diagnostic workup and operative outcome.

All patients were sent the GERD-HRQL questionnaire by mail. This is a validated and standardised questionnaire that is proven effective in reporting quality of life for patients with GERD.[⁸⁹] A maximum score of 75 represents excellent overall quality of life, and a score of 0 reports a very poor quality of life. To make the results easier to compare, we classified this wide score into three groups. A score of 0–25 is classified as a poor outcome, 25–50 as a medium outcome and a quality of life score of ≥50 was classified as a good outcome. Specific items on heartburn and regurgitation both result in a score with a maximum of 30, which represents no burden at all. A score of 0 is associated with a high rate of complaints of the specific symptom. A heartburn or regurgitation score >18 represents elimination of the particular symptom. The questionnaire is attached as https://links.lww.com/JMAS/A0. Non-responders were contacted by phone up to 3 times to maximise the response rate. Only follow-up data regarding respondents are presented.

Surgical technique

All procedures were performed laparoscopically. In all patients, the hiatus was dissected completely and a posterior cruroplasty was performed using non-absorbable braided sutures (Ti-cron™, Covidien, New Haven, CT, USA). The patency must be at least 10 mm besides the oesophagus. If a large hiatal hernia was present, the cruroplasty was reinforced using a non-absorbable prosthetic mesh (Parietex™, Covidien, New Haven, CT, USA) at the discretion of an operating surgeon. After dissection of the short gastric vessels, a 360° floppy Nissen fundoplication was created. We did not use a boogie to calibrate the fundoplication. The most distal suture fixates the wrap to the wall of the oesophagus to prevent telescoping. We did not perform any gastropexy. The patient did receive neither post-operative drain nor epidural analgesia.

Immediate post-operative period

Patients were prescribed a semi-liquid diet for 2 weeks after the operation. Operation time, complications during surgery, length of stay (LOS), in-hospital post-operative complications and re-admissions were retrieved from the hospital information system.

Postoperative follow-up

Patients were examined by the surgeon in the outpatient clinic 8 weeks after discharge. Proton pump inhibitor (PPI) was continued until the first appointment. If no complications were found, the patients were referred to a general practitioner (GP) or gastroenterologist for further follow-up. The medical treatment was evaluated by the GP or gastroenterologist. We did not perform routine pH-studies or endoscopy. We performed additional diagnostics both for pre-operative workup in the case of a re-operation and for persistent or recurrent complaints after the initial procedure.

Statistical analysis

A retrospective database was managed in Access 2010 (Microsoft, USA). All data were analysed using SPSS for MacOS version 21.0 (SPSS Inc., Chicago, IL, USA).

Ethical approval

No ethical approval was required for this study, and permission was granted by the institutional review board of our institution to perform this retrospective study.

RESULTS

Patients characteristics

A total of 231 patients were operated on. Four patients died during follow-up due to cancer, cardiac disease or a car crash. The remaining 227 patients were contacted, of which 175 patients returned the questionnaire, resulting in a response rate of 77.1%. Six patients returned the questionnaire without completing it entirely. No reason was given. Of the remaining 169 operated patients, 72 were male (42.6%). The mean age was 51.6 (range 15–85). The mean follow-up was 3.7 years, with a maximum of 10.3 years.

The most common pre-operative-reported complaints were heartburn (82.8%), regurgitation (26.0%) and chest pain (23.7%). At baseline, 90.5% of the patients used a PPI for heartburn. All baseline characteristics are demonstrated in Table 1.

Table 1: Baseline characteristics

Operative outcome

Almost all patients underwent a laparoscopic Nissen fundoplication with posterior cruroplasty. Only one patient received a Toupet fundoplication; the reason was a specific desire from the patient to receive a Toupet and not a Nissen. In five patients, the operation was performed for recurrent GERD after previous antireflux surgery. On five patients (3.0%), a mesh was used for reinforcement of the cruroplasty because of an unexpected large hiatal hernia. A total of 23 patients underwent re-operation during follow-up. Reasons for re-operation were persistent dysphagia (47.8%) or recurrent heartburn (52.8%). None of the patients were diagnosed with delayed gastric emptying due to vagal nerve injury. The mean LOS was 2 days, with a maximum of 18 days. Mortality rate of the operated patients was zero.

Details regarding operative outcomes are summarised in Table 2.

Table 2: Operative outcome

Complications

In this study, we found a complication rate of 7.1%. Complications included perforation of the stomach, bleeding and opening of the pleura. All complications could be managed during surgery without any further sequelae. However, in a number of cases, this resulted in an extended length of hospital stay. Details regarding the complications can be found in Table 2.

Quality of life

The median overall quality of life score was 70 (range 2–75) at a mean follow-up of 3.7 years. There was no difference in quality of life among patients with a follow-up longer than 5 years, compared with patients with follow-up of <5 years (P = 0.447). Both the heartburn score and the regurgitation score are comparable between short- and long-term follow-up; no statistically significant differences were found. At follow-up, 50.3% of the patients were on PPI compared with 90.9% at baseline (P < 0.05). A complete overview of the quality of life scores is demonstrated in Table 3 and Figure 1. In an extensive analysis to find predictors for quality of life, we only found that the presence of pre-operative belching results in a lower quality of life [Table 4].

Table 3: Quality of life

Figure 1: Quality of life score organized by categories. A Score of 0-25 is classified as 'Poor', 25-50 is classified as 'Medium' and a quality of life score of 50-75 is classified as 'Good'

Table 4: Pre-operative predictors for quality of life

Long-term versus short-term quality of life

Short-term follow-up was defined as <5 years. A total of 115 patients had a follow-up of >5 years, with a median of 1.9 years (range 0.1–4.6). The remaining 54 patients reported a median follow-up of 7.1 years (range 5.1–10.3). The median quality of life was 70.0 for the short-term group, compared with 70.5 for the long-term group (P = 0.447). If we compare post-operative heartburn, regurgitation or usage of PPI, we did not find any statistically significant differences. Results are demonstrated in Table 3.

Re-operation

A total of 23 patients underwent a re-operation during follow-up (13.6%). Eleven patients were re-operated due to persistent dysphagia (47.8%) and 12 due to recurrent heartburn (52.2%) [Figure 2]. The median time to re-operation was 380 days (75–3488 days); 21 (91.3%) re-operations occurred within the first 5 years after the initial operation.

Figure 2: Overview of causes for re-operation. A total of 23 re-operations occurred during follow-up

If dysphagia was the reason for re-operation, the initial Nissen fundoplication was converted to a Toupet. When recurrent heartburn was present, we re-constructed the Nissen fundoplication. In most cases, the wrap seemed to lose, or the sutures were ruptured.

Mean quality of life was 62.7 for patients who did not require re-operation compared to 53.1 for patients who did undergo re-operation (P = 0.196). This latter quality of life is measured after the re-operation was performed.

DISCUSSION

We present a large single-surgeon, single-centre series of patients who underwent laparoscopic Nissen fundoplication for GERD. We demonstrated a great response rate of 77.1%, with a mean follow-up of 3.7 years. In this study, we found excellent quality of life after Nissen fundoplication.

Nissen fundoplication has been proven effective in reducing GERD and preventing recurrence, even at the long-term follow-up.[¹⁰] However, only a few studies demonstrate quality of life after Nissen fundoplication. Several instruments to measure quality of life have been developed over time. There is no consensus which instrument is superior; however, the GERD-HRQL questionnaire has been proven effective in measuring quality of life after Nissen fundoplication for GERD.[⁹¹¹] Since this is a retrospective study, we do not have pre-operative quality of life data. However, we did find a median quality of life score of 70 which is in line with results demonstrated by a large study of Gee et al.[⁸] They describe a large series with a response rate of 54% and a median follow-up of 60 months. Interestingly, we did find that patients who underwent a re-operation did report a lower quality of life score. This result was also found in previously published studies.[⁸¹²¹³] This is probably due to vagal nerve damage, either during the primary procedure or during the re-operation. It is known from the literature that patients with vagal nerve damage have a higher re-operation rate and report less quality of life at the long-term follow-up.[¹⁴] Besides, it seems important to perform proper patient selection in determining who will receive a Nissen fundoplication to prevent re-operation. Based on the current literature, it is recommended to have at least manometry to exclude diseases as achalasia and a 24-h pH measurement in case no reflux oesophagitis is present on endoscopy. Besides, it is preferred that patients should have a good response to anti-acid medication.[¹⁵¹⁶] Unfortunately, due to the retrospective aspect of this study, we could not find all data describing the complete performed pre-operative workup. Furthermore, a total of 55 patients were operated before the introduction of the SAGES guidelines for GERD, and therefore, not all of them did undergo a manometry. We were also unable to find data regarding pre-operative response to anti-acid medication in all patients. We did find that pre-operatively 90.5% of the patients were on PPI, which was reduced to 50.3% at follow-up (P < 0.05). The high percentage of patients who are on PPI on follow-up may contribute to the good reported quality of life. However, we do think that it is more important that patients report good quality of life, rather than being completely free of PPI. Especially since before surgery, they were not satisfied with their situation on PPI.

We found a re-operation rate of 13.6%, from which 7.1% was due to recurrent heartburn. A Heartburn score on the GERD-HRQL of >18 is classified as resolution of symptoms. Based on this score, we found a recurrence in heartburn of 23.7%. This is in contrast with the current literature since the reported recurrent heartburn is about 10%–20% and the actual re-operation rate for recurrent complaints is about 3%–6%.[¹⁷¹⁸] Reported causes for recurrent heartburn are an inadequate indication for surgery due to incomplete pre-operative work-up and failure to execute proper technical steps.[¹⁹] Furthermore, it is known that with increasing experience from the surgeon, the complication and re-operation rate will decrease.[²⁰²¹] As mentioned before, it is known that patients with vagal nerve damage receive more frequent re-operations.[¹⁴] Since this was a retrospective study, we were unable to determine whether the patients who underwent a re-operation indeed had vagal nerve injury. Our higher re-operation rate is most likely due to a combination of above-mentioned factors.

Eleven of the 23 re-operation were due to persistent dysphagia. This is a common side effect of Nissen fundoplication and a large meta-analysis by Tian et al. in 2015 demonstrates a post-operative dysphagia rate of 12.6% in patients who underwent Nissen fundoplication.[²²] In this study, 8.9% of the patients had moderate-to-severe dysphagia, which might be an indication for re-operation. This is comparable with the 6.5% re-operations for dysphagia in our study. Post-operative dysphagia is a known and major problem, and re-operation rates between 1.8% and 10.8% for dysphagia have been reported in literature.[²] To reduce dysphagia, some authors advocate to perform a Toupet fundoplication. Despite the lower dysphagia rate, this technique seems to be inferior in controlling GERD symptoms at the long term.[²³] However, there are also studies that report comparable control of GERD symptoms with less post-operative complications and therefore advocate to perform a Toupet fundoplication.[²²] We believe that it is important to perform the technique in which the surgeon has the most experience. In case of persistent post-operative dysphagia, a Nissen can be converted to a Toupet, and in case of insufficient reflux control after a Toupet, this can be converted to a Nissen. The final decision to perform either Nissen or Toupet should be tailored made.

Another outcome measurement in this study was the complication rate. We found a complication rate of 7.1% which is in line with the overall complication rate of 6.3% that is reported in a large meta-analysis by Memon et al. in 2015.[²⁴] All complications were minor and could be managed during surgery without any further sequelae. The median time to re-operation was 380 days.

Some authors report the relevance of long-term results after antireflux surgery. However, if we compare quality of life after a follow-up of <5 years with results after >5 years, we do not see any statistically significant difference. This may suggest that most complications and recurrences occur within the first 5 years after initial surgery. This hypothesis is supported by the fact that almost all re-operations 21/23 (91.3%) were performed within 5 years after the primary procedure. Therefore, we might conclude that follow-up of 5 years after Nissen fundoplication might be sufficient to evaluate its effectiveness. This is supported by the study of Kelly et al. where they report that most re-operations are performed within the first 2 years and that they did not see any difference in symptomatic outcome between 5 and 10 years of follow-up.[⁷]

CONCLUSION

We report a large series of single centre, single-surgeon laparoscopic Nissen fundoplication. Despite the re-operation rate of 13.6%, we found excellent symptomatic outcome at a median follow-up of 3.7 years. We did not find any difference between short-term and long-term results; therefore, follow-up of 5 years might be sufficient to evaluate the results of Nissen fundoplication since 91.3% of the re-operations took place within 5 years. Patients who underwent re-operation experienced less quality of life; this might be due to vagal nerve injury; however, this requires more research.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.