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 ¤  Abstract
 ¤ Introduction
 ¤ Patients and Methods
 ¤ Results
 ¤ Discussion
 ¤ Conclusion
 ¤  References
 ¤  Article Figures
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 Table of Contents     
ORIGINAL ARTICLE
Year : 2017  |  Volume : 13  |  Issue : 3  |  Page : 208-214
 

A long-term evaluation of the quality of life after laparoscopic Nissen-Rossetti anti-reflux surgery


Department of Emergency, Emergency and Minimally Invasive Surgery Unit, Careggi University Hospital, Florence, Italy

Date of Submission02-Jun-2016
Date of Acceptance19-Nov-2016
Date of Web Publication12-Jun-2017

Correspondence Address:
Giovanni Alemanno
Emergency and Minimally Invasive Surgery Unit, Careggi University Hospital, Largo Brambilla 3, 50134 Florence
Italy
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-9941.205872

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 ¤ Abstract 

Background: The quality of life (QoL) has been suggested to be the most relevant parameter to assess and monitor the long-term outcome in patients who underwent surgery for gastroesophageal reflux disease (GERD). Patients and Methods: A retrospective evaluation was conducted on patients who underwent Laparoscopic Nissen-Rossetti Fundoplication for GERD between January 1998 and December 2010. To evaluate the long-term results a telephone interview was made using the VISICK score and the GERD-health-related QoL (HRQL) questionnaire at 1, 3, 5 years and at the end of the study. If the questionnaires resulted unsatisfactory, a complete diagnostic revaluation was performed. Results: A total of 168 patients underwent laparoscopic surgery for GERD. When evaluated at the end of the study, the number of unsatisfied patients according to the VISICK score was significantly higher than the one obtained with the GERD-HRQL questionnaire. Conclusions: Many data suggest a possible recurrence of the symptoms after surgery in a long follow-up period. Our data seem to demonstrate a slight but significant trend in symptoms relapse after surgery. Considering the non-specific and specific nature of the two scores, VISICK and GERD HRQL, our result showed a significantly more relevant trend of symptoms relapse only for the non-specific ones. Such QoL scores seem to be important in selecting patients who need to be instrumentally examined. Consequently, our work proves that only a few patients out of the total number of followed up patients, are to be recalled to undergo instrumental examination.


Keywords: Gastroesophageal reflux disease, gastroesophageal reflux disease-health-related quality of life, laparoscopic Nissen-Rossetti fundoplication, quality of life, VISICK


How to cite this article:
Alemanno G, Bergamini C, Prosperi P, Bruscino A, Leahu A, Somigli R, Martellucci J, Valeri A. A long-term evaluation of the quality of life after laparoscopic Nissen-Rossetti anti-reflux surgery. J Min Access Surg 2017;13:208-14

How to cite this URL:
Alemanno G, Bergamini C, Prosperi P, Bruscino A, Leahu A, Somigli R, Martellucci J, Valeri A. A long-term evaluation of the quality of life after laparoscopic Nissen-Rossetti anti-reflux surgery. J Min Access Surg [serial online] 2017 [cited 2020 Feb 21];13:208-14. Available from: http://www.journalofmas.com/text.asp?2017/13/3/208/205872



 ¤ Introduction Top


Gastroesophageal reflux disease (GERD) is caused by the failure of the anti-reflux barrier and consists in the abnormal reflux of the gastric contents into the oesophagus.[1]

According to the Montreal Consensus, GERD was defined as 'a condition which develops when the reflux of the stomach contents causes troublesome symptoms and/or complications'.[2]

This common condition is characterised by the presence of a variety of symptoms which include heartburn, retrosternal pain or regurgitation, and can significantly impair the quality of life (QoL). Moreover, when these last for a long period, GERD can cause serious complications such as esophageal strictures, Barrett's oesophagus or adenocarcinoma. The aim of the treatments is, therefore, the symptoms resolution, the healing of esophagitis and the prevention of complications and recurrence.

Unfortunately, the most clinically and cost-effective treatment of GERD whether medical or surgical management is still to be clarified. Indeed, although proton-pump inhibitors (PPI) are effective in the treatment of esophagitis and short-term symptoms control, according to some authors, different studies have demonstrated that up to 40% of patients continue to experience abnormal acid reflux and up to 35% have a relapse of the symptoms during a 3-year follow-up.[3],[4],[5]

According to the 'Guidelines for Surgical Treatment of GERD', surgery should be considered in patients who have failed medical management or in patients who opt for surgery despite successful medical management. This may be due to the low QoL of patients with a lifelong prospect of drugs intake, including the expenses for medication, or when patients experience GERD complications or extraesophageal events such as asthma, cough, chest pain and aspiration.[6]

Unfortunately, most of the studies that have sought to analyse which might be the best therapeutic choice for long-lasting GERD have been characterised by a short to medium-term follow-up. In the review conducted by Wileman et al., including four trials, with a total of 1232 randomised participants, the authors demonstrated, in a mean follow-up of 3 years, that laparoscopic fundoplication was more effective than medical therapy for the treatment of GERD.[7] Moreover, in the randomised multicenter trial with a post-operative follow-up of 5 years, conducted by Lundell et al., authors found anti-reflux surgery to be more effective than omeprazole in controlling GERD, as measured by treatment failure rates.[5] Another important topic is the way to assess the symptoms persistence or recurrence after surgery.[8] QoL has been suggested to be the most relevant parameter for this purpose. To assess and monitor the long-term outcome in patients who underwent surgery for GERD, an extensive use of the QoL score was made successfully for many years. The most widely used scores are surely the VISICK grading system [9],[10] which is an extensively validated and reliable system. Although it is very sensitive for the perception of QoL, it might be considered non-aspecific, since it is not specifically referred to GERD symptoms. On the other hand, the GERD-health-related QoL (HRQL) questionnaire, developed by Velanovich,[11] which consists in ten very specific questions for GERD disorders, is a disease-related QoL tool, considered to be highly specific.

The aim of this study was, therefore, to evaluate the long-term results in patients laparoscopically treated for GERD, considering the two QoL scores of VISICK and GERD-HRQL.


 ¤ Patients and Methods Top


A retrospective evaluation was conducted on the patients who underwent laparoscopic surgery for GERD between January 1998 and December 2010 at the General, Emergency and Minimally Invasive Surgery Unit of the Careggi University Hospital in Florence. The data were collected from operating room registers and chart records. In the chart records, we evaluated all data regarding pre-operative studies, surgery and post-operative outcome until the time of the patient's discharge.

Pre-operative evaluation

All patients, off of PPIs for almost 30 days, were preoperatively evaluated with all the examinations listed below. The instrumental workup consisted of: An upper gastrointestinal endoscopy, which led to the confirmation of the diagnosis of GERD or led to biopsies; an Esophageal Manometry which facilitated the identification of conditions that might discourage fundoplication, such as achalasia, and the 24-h Esophageal pH Monitoring, which is important when there is a diagnostic uncertainty. GERD was diagnosed when a drop in pH <4 lasted for >5% of the monitoring period.

Surgical indications

When the diagnosis of reflux was confirmed, surgical therapy was considered either in patients who failed the medical management (for an inadequate symptom control or a severe regurgitation not controlled with PPIs or for medication side effects), or in patients who opted for surgery despite successful medical management (due to the low QoL in a lifelong prospect of drugs intake and the expenses of medication) or had GERD complications, or extraesophageal events as asthma, cough, chest pain and aspiration, according to the 'Guidelines for Surgical Treatment of GERD'.[6]

Surgical technique

Laparoscopic Nissen-Rossetti Fundoplication (with 5 trocars) was performed with the mobilisation of the fundus posteriorly to the upper pole of the spleen without the division of the short gastric vessels (SGV) in 142 patients (84.5%) and with the division of the SGV in 26 patients (15.5%). The correct identification of anatomical landmarks (the anterior surface of the oesophagus, the right and the left crus), the mobilisation of the fundus to build a floppy fundoplication, the mobilisation of 3–4 cm of intra-abdominal oesophagus to avoid tension, and the calibration of the fundoplication with a large boogie, were respectively performed. In the event of an enlarged hiatus, a posterior hiatoplasty was performed with nonabsorbable stitches or with a polypropylene mesh, if necessary. A nasogastric tube was always left in the stomach.

Post-operative treatment

In the 1st post-operative day, all patients underwent Gastrografin ® swallow X-ray examination and then started with liquid intake. In the 2nd post-operative day, after consulting a dietician, an adequate food intake program was provided, to be continued also after discharge.

Follow-up

Patients were checked in our outpatient clinic 1 week after discharge. The follow-up protocol included the possibility of an on-call activation of our surgical team in case of adverse abdominal symptoms.

Clinical endpoint

To evaluate the long-term results in patients laparoscopically treated for GERD, considering the outcome of the treatment and QoL scores, a telephone interview was made to all patients using two methods: The VISICK score and the GERD-HRQL questionnaire at 1, 3, 5 years and at the end of the study. Patients expressed their satisfaction when the post-operative VISICK scores [Table 1] were within in Grade I or II. Moreover, the GERD-HRQL questionnaire includes ten questions with scores between 0 and 5 for each question, and an additional question which evaluates the patient's satisfaction with his/her current condition [Table 2]. The best possible aggregate score is 0 (absence of symptoms), and the worst is 50 (very severe symptoms).
Table 1: VISICK classification of upper gastrointestinal symptoms

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Table 2: Gastroesophageal reflux disease-health-related quality of life questionnaire

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If the questionnaires resulted unsatisfactory, (Grade III–IV of the VISICK scale and the response was 'unsatisfied' to the GERD-HRQL questionnaire) a complete diagnostic evaluation with endoscopy, esophageal manometry and 24-h Esophageal pH-Monitoring were performed to determine the causes of the failure of the previous treatment.

Statistical analysis

Data were expressed as a mean ± standard deviation. Statistical analysis was performed with the Chi-square test, Fisher exact test or t-test. Statistical significance was set at P< 0.05. Data were analysed using the SPSS statistical software, IBM ® (New York, United States).


 ¤ Results Top


From January 1998 up to December 2008, 168 patients underwent laparoscopic surgery for GERD. The general characteristics of the population of the study are reported in [Table 3].
Table 3: General characteristics of the population of the study

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All patients had a long history of GERD treated with PPI therapy, which was ineffective in controlling symptoms in 93%. Sixty patients (45%) had atypical GERD symptoms, namely chronic cough or chest pain in 39%, asthma in 10% and chronic sinusitis in 5% of cases.

In 91 patients (78%), a sliding hiatal hernia was endoscopically evidenced. Erosive esophagitis (assessed with the Savary-Miller grading system) was found in 53 patients (40%).

There was no conversion from laparoscopic to open surgery. The average operating time was 80 ± 60 min (range 70–120). There were three intraoperative complications (bleeding), with no need for conversion to open surgery. Patients were discharged after 2 days in 113 cases (85%). Twenty-one patients required a 3-day hospitalisation for pain control (n = 3), transient dysphagia (n = 4), delayed gastric empting (n = 2), respiratory and urinary tract infection (n = 4). No perioperative mortality was found.

When examining the trend of the VISICK and GERD-HRQL score throughout the years, an increase (worsening) of both scores was observed, but it was only significant in the VISICK, after the first 5 years (P = 0.03), as shown in [Figure 1].
Figure 1: The trend of the VISICK and gastroesophageal reflux disease-health-related quality of life score throughout the years

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When evaluated at the end of the study (median follow-up time 110 ± 3 months), the number of unsatisfied patients according to the VISICK score (43 patients, 32%) was significantly higher (P = 0.004) than the one obtained with the GERD-HRQL questionnaire (23 patients, 18%), as reported in [Figure 2].
Figure 2: Comparison between the number of unsatisfied patients according to the VISICK score and the gastroesophageal reflux disease-health-related quality of life questionnaire

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It is worth mentioning that as the group of patients who were unsatisfied according to the GERD-HRQL questionnaire (23 patients), was included in the group of patients unsatisfied according to the VISICK score (43 patients), two sub-groups of patients were selected among the whole number of unsatisfied patients. The first one, named V + G−, included patients unsatisfied to VISICK but satisfied to GERD-HRQL (20 patients). The second one, called G+, included patients unsatisfied to both scores, (23 patients).

[Table 4] shows the general features of patients belonging to the two groups. It is worthy of mentioning that age, body mass index (BMI) and American Society of Anesthesiologists (ASA) at time of surgery were significantly higher in the V+G− group.
Table 4: General features of patients belonging to the two groups: V+G- and G+

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The results of the comparison between the two groups, V+G− and G+, for the typical relapse symptoms, are reported in [Table 5]. It appears evident that all the non-specific symptoms, except for the sub-occlusion, had a significantly high rate in the V+G− group while, among the typical symptoms, regurgitation had a significantly higher rate in the G+ group.
Table 5: Comparison between V+G- and G+groups for the typical relapse symptoms

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The results of instrumental examinations in the V+G− and G+ groups are shown in [Table 6]. The upper gastrointestinal endoscopy showed normal results in a significantly higher number of patients from the V+G− group, while the endoscopic evidence of esophagitis was significantly higher in the G+ group. Finally, the 24-h Esophageal pH-Monitoring showed normal results in a significantly higher number in patients from the V+G− group, while a significantly higher rate of alkaline reflux was evidenced in the G+ group. Manometry, instead, did not show different results in the two groups.
Table 6: Results of instrumental examinations in the V+G- and G+groups

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 ¤ Discussion Top


There has been a time-long lively debate on which would be the best treatment of chronic GERD, whether proton pomp inhibitors or surgery.[3],[4],[5] Actually, since the first description of the laparoscopic fundoplication technique by Dallemagne et al. in 1991,[12] surgery started to be increasingly exposed to resistant or intolerant patients to PPI, due to the undoubtable advantages in the post-operative outcome of this technique. However, nowadays many data seem to suggest a possible recurrence of the symptoms after surgery, in a long follow-up period of >5 years,[13],[14] even though there is evidence only in few reports on this topic.[15],[16],[17] In particular, in a significant trial by Hatlebakk et al.,[17] the efficacy and safety of laparoscopic anti-reflux surgery (LARS) versus esomeprazole (20 or 40 mg/d) over 5 years in patients with chronic GERD were compared. Authors came to the conclusion that patients receiving LARS had a significantly lower exposure to 24-h esophageal acid release, after 6 months and 5 years. Conversely, in the large retrospective case series by Van Meer et al.,[14] authors reported still a high prevalence of typical reflux symptoms and daily PPI use in GERD patients after >5 years of follow-up. There is evidence that the daily usage of PPI increases with age.

Recently, a case series of 100 prospectively followed up patients for more than 20 years has been reported.[15] The authors seem to be in favour of the surgical approach, and have proven that there is a long-term follow-up documentation of good patient satisfaction and durable symptom relief, up to two decades after laparoscopic fundoplication for GERD. According to their determined opinion, patients should opt for this operation not only to achieve symptomatic relief, but also to mitigate the negative effects of long-term acid exposure and anti-acid therapy. However, their work shows the bias of a small number of case series, which is exacerbated by the high drop-out rate (11%). Nevertheless, other authors [18] have pointed out that the risk of PPI usage after ARS seems to be actually higher than previously reported, since, in their opinion, >50% of patients become long-term PPI users 10–15 years after surgery. These authors add that surgeons should therefore inform patients that long-term PPI therapy is often necessary after ARS.

Our data exercise a significant impact in this controversial panorama. Indeed, in our department when we have performed, in 1988, the first laparoscopic fundoplication, according to the Nissen-Rossetti description, we have created a database of laparoscopically treated patients for GERD, to retrospectively evaluate their follow-up. In particular, for each patient, we sought to evaluate the surgical outcome after 1, 3, 5 and 10 years. To examine the long-term follow-up of >5 years, we therefore aimed to evaluate only the population of patients operated on from the beginning to 2010. We have, thus, evaluated a case series of >100 patients with a mean follow-up of approximately >9 years, which is one of the longest periods of time reported in literature. Our results seem to demonstrate a slight but significant trend in symptoms relapse after surgery. This statement is, however, referred only to non-specific and specific gastrointestinal symptoms.

One major issue in long-term operated patients follow-up is the drop-out phenomenon, which is mainly due to their usually poor compliance to go to the outpatient clinic, especially in case of asymptomatic subjects. To curb as much as possible this phenomenon, we followed up our patients using the simple method consisting in a telephonic interview. However, which method should be used in the historical interview, to verify the persistence or relapse of GERD symptoms is still being debated, and many different scores have been used by different authors. Among all the scores used, some are non-specifically related to the QoL, since the symptoms related to GERD significantly contribute to decrease the patients QoL. Others more specifically refer to the changes in disease-related symptoms. Among these, the GERD-HQRL is one of the most frequently used. Both scores seem to be very simple to be administered and can be applied also during telephone interviews. Nevertheless, our drop-out rate remained high (20%), except for a few cases due to a real impediment of the patients (death, severe disease, etc.), while in most of cases the reason for dropping-out was due to patients moving out, without providing their new contacts. From these lessons, we have learned that, in case of long term follow-up, it is necessary to be as much accurate as possible in recording the patients contacts and to ask them to advise in case of any changes, as for example of their telephone numbers.

As to the follow-up results, considering the above-mentioned non-specific and specific nature of these two scores, VISICK and GERD HRQL, our result showed a significantly more relevant trend of symptoms relapse only for the non-specific ones which is, in our opinion, quite relevant. There may be, however, results in contrast with those of other authors researching on the topic of symptoms relapse after surgery. Indeed, a more non-specific score system (such as the VISICK) could tend to give worse results over a long term follow-up, while the most specific ones for the reflux syndrome indicative of a true relapse of the GERD, such as GERD-HRQL, tends to remain stable for a few years, proving that results might have been positive and surgery a safe method. We, therefore, hope for a more uniform method of analysis of the surgical results of ARS over a long-term follow-up.

Such QoL scores seem to be important in selecting patients who need to be instrumentally examined from those who do not need examination. Consequently, our work proves that only a few patients out of the total number of followed up patients, are to be recalled to undergo instrumental examination. Indeed, among the asymptomatic patients, the rate of the ones still affected with gastroesophageal reflux problems and complications are a true exception. On the other hand, this limitation of the patients examined with gastroscopy and manometry/pH-metry, may be important in reducing the rate of the drop-out phenomenon. In our case, such drop-out rate among re-called patients for a free follow-up was 0%.

The application of these two different scores may have another important consequence, namely, our data show that patients belonging to the G+ group experienced a full-blown esophagitis more frequently. Thus, such score could highlight a true relapse of the GERD which will require a new therapy. Yet, this group of patients does not seem to need a new operation, due the prevalent alkaline origin of their symptoms, as shown by our results.

Conversely, the V+G− group of patients don not seem to share a true complication or relapse, but only non-specific symptoms of the previous surgery. These usually belong to a high-risk class of patients for surgery, due to their higher age, ASA and BMI at the time of first surgery. It is mandatory, to inform this category of patients about the high frequency of general adverse long-term symptoms even in case of a good surgical outcome, to prepare them to possible problems not related to this kind of intervention, thus limiting the possibility of claims to the surgeons.


 ¤ Conclusion Top


Many data suggest a possible recurrence of the symptoms after surgery in a long follow-up period. Our data seem to demonstrate a slight but significant trend in symptoms relapse after surgery. Considering the non-specific and specific nature of the two scores, VISICK and GERD HRQL, our result showed a significantly more relevant trend of symptoms relapse only for the non-specific ones. Such QoL scores seem to be important in selecting patients who need to be instrumentally examined. Consequently, our work proves that only a few patients out of the total number of followed up patients, are to be recalled to undergo instrumental examination.

Acknowledgement

We would like to thank Prof. Maria Rosaria Buri, Professional Translator/Aiic Conference Interpreter, University of Salento, for English language editing (http://www.mariarosariaburi.it).

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
 ¤ References Top

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Wetscher GJ, Redmond EJ, Vititi LM. Pathophysiology of gastroesophageal reflux disease. In: Hinder RA, editor. Gastroesophageal Reflux Disease. Austin: Landes; 1993. p. 7-29.  Back to cited text no. 1
    
2.
Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: A global evidence-based consensus. Am J Gastroenterol 2006;101:1900-20.  Back to cited text no. 2
    
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Anvari M, Allen C, Marshall J, Armstrong D, Goeree R, Ungar W, et al. A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes. Surg Endosc 2011;25:2547-54.  Back to cited text no. 3
    
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Gerson LB, Boparai V, Ullah N, Triadafilopoulos G. Oesophageal and gastric pH profiles in patients with gastro-oesophageal reflux disease and Barrett's oesophagus treated with proton pump inhibitors. Aliment Pharmacol Ther 2004;20:637-43.  Back to cited text no. 4
    
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Lundell L, Miettinen P, Myrvold HE, Pedersen SA, Liedman B, Hatlebakk JG, et al. Continued (5-year) followup of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease. J Am Coll Surg 2001;192:172-9.  Back to cited text no. 5
    
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Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD; SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc 2010;24:2647-69.  Back to cited text no. 6
    
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Wileman SM, McCann S, Grant AM, Krukowski ZH, Bruce J. Medical versus surgical management for gastro-oesophageal reflux disease (GORD) in adults. Cochrane Database Syst Rev 2010;3:CD003243.  Back to cited text no. 7
    
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Dent J, Armstrong D, Delaney B, Moayyedi P, Talley NJ, Vakil N. Symptom evaluation in reflux disease: Workshop background, processes, terminology, recommendations, and discussion outputs. Gut 2004;53 Suppl 4:iv1-24.  Back to cited text no. 8
    
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Visick AH. A study of the failures after gastrectomy. Ann R Coll Surg Engl 1948;3:266-84.  Back to cited text no. 9
    
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Rijnhart-De Jong HG, Draaisma WA, Smout AJ, Broeders IA, Gooszen HG. The Visick score: A good measure for the overall effect of antireflux surgery? Scand J Gastroenterol 2008;43:787-93.  Back to cited text no. 10
    
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Velanovich V. Comparison of generic (SF-36) vs. disease-specific (GERD-HRQL) quality-of-life scales for gastroesophageal reflux disease. J Gastrointest Surg 1998;2:141-5.  Back to cited text no. 11
    
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Dallemagne B, Weerts JM, Jehaes C, Markiewicz S, Lombard R. Laparoscopic Nissen fundoplication: Preliminary report. Surg Laparosc Endosc 1991;1:138-43.  Back to cited text no. 12
    
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Lundell L, Bell M, Ruth M. Systematic review: Laparoscopic fundoplication for gastroesophageal reflux disease in partial responders to proton pump inhibitors. World J Gastroenterol 2014;20:804-13.  Back to cited text no. 13
    
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Van Meer S, Bogte A, Siersema PD. Long-term follow up in patients with gastroesophageal reflux disease with specific emphasis on reflux symptoms, use of anti-reflux medication and anti-reflux surgery outcome: A retrospective study. Scand J Gastroenterol 2013;48:1242-8.  Back to cited text no. 14
    
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Sadowitz BD, Luberice K, Bowman TA, Viso AM, Ayala DE, Ross SB, et al. A single institution's first 100 patients undergoing laparoscopic anti-reflux fundoplications: Where are they 20 years later? Am Surg 2015;81:791-7.  Back to cited text no. 15
    
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Rosemurgy A, Paul H, Madison L, Luberice K, Donn N, Vice M, et al. A single institution's experience and journey with over 1000 laparoscopic fundoplications for gastroesophageal reflux disease. Am Surg 2012;78:917-25.  Back to cited text no. 16
    
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Hatlebakk JG, Zerbib F, Bruley des Varannes S, Attwood SE, Ell C, Fiocca R, et al. Gastroesophageal acid reflux control 5 years after antireflux surgery, compared with long-term esomeprazole therapy. Clin Gastroenterol Hepatol 2016;14:678-85.e3.  Back to cited text no. 17
    
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Lødrup A, Pottegård A, Hallas J, Bytzer P. Use of proton pump inhibitors after antireflux surgery: A nationwide register-based follow-up study. Gut 2014;63:1544-9.  Back to cited text no. 18
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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