Dimitrios P. Korkolis, PhD, MD Maria Kapritsou, MSc, BSN, RN Evangelos A. Konstantinou, PhD, RN Margaret Giannakopoulou, PhD, RN Maria S. Chrysi, MSc, RN Maria Tsakiridou, RN Andriana Kouloura, MD Matthaios Flamourakis, MD Mariantonietta Maricosu, MD Emmanuil Gontikakis, PhD, MD George Plataniotis, MD
The Impact of Laparoscopic Nissen Fundoplication on the Long-Term Quality of Life in Patients With Gastroesophageal Reflux Disease ABSTRACT Laparoscopic Nissen fundoplication is now the most common surgical procedure for treatment of gastroesophageal reflux disease (GERD), offering promising long-term outcomes. Outcomes for 46 patients with GERD who underwent Nissen fundoplication during the last 5 years (November 2007–June 2012) were prospectively studied using a structured questionnaire that evaluated clinical symptom scores for heartburn, dysphagia, and satisfaction with clinical outcomes. Postoperative care of the patients including analgesia, median hospital stay, overall cost, and complications was also studied. Clinical follow-up data for 2 years after surgery were available for all 46 patients. Forty-two patients (91.3%) were satisfied with their quality of life and only eight patients (17.4%) continued to receive antacids after surgery. Dysphagia to solid and liquid occasionally appeared in 26.1% (N = 12) and 17.4% (N = 8) of patients, respectively. Laparoscopic Nissen fundoplication was an effective long-term treatment for GERD. The operation resulted in a significant reduction of symptoms and minimized the use of antacid drugs with a high degree of patient satisfaction. Although some patients may have returned to antacid treatment at late follow-up or continued to complain of mild discomfort, they were overall pleased with the outcome.
Received February 8, 2013; accepted October 29, 2013. About the authors: Dimitrios P. Korkolis, PhD, MD, is Consultant Surgeon, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Maria Kapritsou, MSc, BSN, RN, is Nurse, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece, and National and Kapodistrian University of Athens, Athens, Greece. Evangelos A. Konstantinou, PhD, RN, is Assistant Professor of Nursing Anesthesiology, National and Kapodistrian University of Athens, Athens, Greece. Margaret Giannakopoulou, PhD, RN, is Assistant Professor, National and Kapodistrian University of Athens, Athens, Greece. Maria S. Chrysi, MSc, RN, is Nurse, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Maria Tsakiridou, RN, is Head Chief Nurse of Surgical Clinic, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece.
VOLUME 38 | NUMBER 2 | MARCH/APRIL 2015
Andriana Kouloura, MD, is Resident in Surgery, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Matthaios Flamourakis, MD, is Resident in Surgery, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Mariantonietta Maricosu, MD, is Resident in Surgery, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Emmanuil Gontikakis, PhD, MD, is Director of Surgical Clinic, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. George Plataniotis, MD, is Director of Surgical Clinic, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. The authors declare no conflicts of interest. Correspondence to: Konstantinou A. Evangelos, RN, BSN, MSc, PhD, Nursing Anesthesiology, National and Kapodistrian University of Athens, Athens, Greece ([email protected]). DOI: 10.1097/SGA.0000000000000097
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Introduction The invention of the video laparoscope has recently changed the field of the modern surgery. Complex surgical procedures can be performed laparoscopically, with minimal disruption of patients’ life and a remarkable reduction in postoperative pain (Altun et al., 2012). Gastroesophageal reflux disease (GERD) is a common condition in which the lower esophageal sphincter allows gastric acids to reflux into the esophagus. Symptoms such as heartburn, regurgitation, dysphagia, and chronic lung disease may occur. Damage to the esophageal mucosa may result in severe esophagitis, ulceration, strictures, or Barrett’s esophagus (Locke, Talley, Fett, Zinsmeister, & Melton, 1997). Since fundoplication was reported by Rudolf Nissen in 1956, this procedure or modifications of it have become widely accepted for the surgical management of GERD with a long-term relief of symptoms in more than 90% of patients (Anvari & Allen, 1998). Laparoscopic Nissen fundoplication (LNF) is well established as an effective surgical therapy for the treatment of GERD, yielding substantial symptomatic improvement and reduction in the use and cost of antacid medications (Altun et al., 2012; Kamolz, Bammer, Wykypiel, Pasiut, & Pointner, 2000; Locke et al., 1997; Rattner, 2000; Wahlqvist, 2001). In a fundoplication, the gastric fundus (upper part) of the stomach is wrapped, or plicated, around the lower end of the esophagus and stitched in place, reinforcing the closing function of the lower esophageal sphincter. The esophageal hiatus is also narrowed down by sutures to prevent or treat concurrent hiatal hernia in which the fundus slides up through the enlarged esophageal hiatus of the diaphragm (Anvari & Allen, 1998; Nissen, 1961; Schietroma et al., 2013).
marked. Finally, the cost of the surgery that is referred to as the cost of surgical instruments was presented. All surgeries were performed by the same surgical team (D.P.K., E.G., and G.P.). Statistical analysis was initiated using SPSS 18 (IMB SPSS Software, Chicago, Illinois) and compared the above mentioned parameters. The data were expressed as mean ± SD. Data was retrieved for the literature review from the databases PubMed, MEDLINE, and Google Scholar. Studies with qualitative and quantitative orientation were included. Sixty-three studies were identified evaluating outcomes of LNF.
Results Demographic Data The demographic data of the patients who have undergone LNF are shown in Table 1. The cause of hospitalization is shown in Table 2.
Postoperative Recovery The average time for early activity was 1.22 days (range = 1–2 days), whereas return to regular diet was 1.57 days (range, 1–3). The total hospitalization period after LNF was an average of 4 days, (range, 2–17 days). Perioperative antibiotics were administrated for an average of 1.61 days (range, 1–4 days). Intravenous liquids were given for an average of 1.83 days (range, 1–4 days) (Table 3).
Fever and Nausea Just over four percent of the patients (N = 2) developed fever during the first postoperative day, whereas nine of the patients (19.56%) complained for some nausea or vomiting.
Methods This study was conducted at the Hellenic Anticancer Institute “Saint Savvas” Hospital, Athens, Greece. The protocol has been approved by the Scientific Committee of Hellenic Anticancer Institute “Saint Savvas” Hospital. All 46 consecutive patients suffering from GERD were treated with LNF from November 2007 to June 2010 and were prospectively followed up for 2 years after the operation to evaluate the long-term outcomes. Outcome measures included a questionnaire about symptoms such as dysphagia to solid or liquids, the use of antacids, and improvement of their everyday quality of life. Furthermore, the parameters such as gender, age, diagnosis of illness, postoperative analgesia, day of mobilization, and day of starting normal diet were calculated. Likewise, information was assembled on the total of days of intravenous administration of liquids and antibiotics. The complications were 112 Copyright © 2015 Society of Gastroenterology Nurses and Associates
TABLE 1. Patient Characteristics Laparoscopic Nissen Fundoplication
N = 46
Age at surgery (years) 20–29
4 (8.7%)
30–39
2 (4.3%)
40–49
10 (21.7%)
50–59
10 (21.7%)
60–69
12 (26.1%)
70–79
8 (17.4%)
Gender Male
22 (47.8%)
Female
24 (52.2%)
Gastroenterology Nursing
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TABLE 2. Cause of Hospitalization Laparoscopic Nissen Fundoplication
N = 46
Barrett’s esophagus
8 (17.4%)
Gastroesophageal reflux disease
24 (52.2%)
Hiatal hernia
14 (30.4%)
TABLE 3. Postoperative Recovery Parameters
Laparoscopic Nissen Fundoplication (n = 46)
Early activity (days)
1.20 ± 0.443
Time to resume regular diet (days)
1.57 ± 0.583
Length of stay (days)
4 ± 3.565
Antibiotics (days)
1.61 ± 0.829
Intravenous liquids (days)
1.83 ± 0.926
TABLE 5. Analgesia of First Postoperative Day
Analgesia
Laparoscopic Nissen Fundoplication (n = 46)
No analgesia
47.8%
Pethidine
4.3%
Paracetamol
4.3%
Tramadol
8.7%
Paracetamol + Codeine
4.3%
Paracetamol + dextropropoxyphene hydrochloride
26.1%
Dextropropoxyphene hydrochloride
4.3%
Cost of Surgery The cost of the surgery primarily includes the cost of surgical tools. The surgical cost for the LNF group was an average of 2,876.3757 euros ($11,368.10 US) (range, 850.45–7,030.74 euros [$963.12–$6207.17]).
Analgesia Postoperative analgesia was determined during the day of the surgery as well as the first and second postoperative days. Table 4 shows that 21.7% (N = 10) of the patients did not feel any pain during the day of the surgery whereas 69.6% (N = 32) of the patients complained for a moderate/mild pain. In the first postoperative day, 47.8% (N = 22) of the patients did not receive any painkillers, whereas only the 4.3% (N = 2) patients received drugs for intense and persistent wound pain (Table 5). In the second postoperative day, 91.3% (N = 42) of the patients had no pain at all (Table 6).
TABLE 4. Analgesia of the Day of the Surgery Surgical Analgesia
Laparoscopic Nissen Fundoplication (n = 46)
Morphine
4.3%
Pethidine + paracetamol
4.3%
Paracetamol
30.4%
Tramadol
4.3%
Tramadol + paracetamol
4.3%
Paracetamol + dextropropoxyphene hydrochloride
26.1%
Paracetamol + dextropropoxyphene hydrochloride + tramadol
4.3%
No analgesia
21.7%
Long-Term Quality of Life Patients were seen at the clinic every 3 months for 2 years after the surgery. At the visit, patients were asked to complete a questionnaire designed to assess patient satisfaction, medication use, and symptoms. Patients who did not return for follow-up received questionnaires by mail or were contacted by telephone. Patients were asked to mention how often they have symptoms such as dysphagia to solid and liquids, early satiety, and eructation. The questionnaire also asked patients to bring up whether they had gastroesophageal reflux symptoms again or had to receive antacid medications again after the surgery by marking either a ‘yes’ or ‘no’ answer. Finally, patients were asked whether or not they were pleased with their everyday life and their quality of life—whether the symptoms of GERD were diminished or they no longer existed— after the surgery with a simple ‘yes’ or ‘no’. Two years after the surgery, the entire series of patients returned identical questionnaires and their responses at that point in time.
TABLE 6. Analgesia of Second Postoperative Day Analgesia
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Laparoscopic Surgery (n = 48)
No analgesia
91.3%
Paracetamol + dextropropoxyphene hydrochloride
4.3%
Paracetamol + codeine
4.3%
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TABLE 7. Questionnaire for Quality of Life (A) Not At All
Occasionally
Quite Often
Often
Dysphagia to solids
65.2%
26.1%
4.3%
4.3%
Dysphagia to liquids
82.6%
17.4%
0%
0%
Early satiety
30.4%
39.1%
21.7%
8.7%
Flatulence
43.5%
52.2%
4.3%
0%
Vomiting
82.6%
17.4%
0%
0%
Diarrhea
73.9%
26.1%
0%
0%
Eructation
47.8%
52.2%
0%
0%
Overall, 42 respondents (91.3%) were satisfied with the operative experience at the time of followup because of the improvement of their everyday life, while 65.2% (N = 30) and 82.6% (N = 38) of the patients did not have dysphagia to solid and liquids anymore (Tables 7 and 8).
Discussion Gastroesophageal reflux disease is a common disorder in the western population; periodically, symptoms occur in approximately 20% of adults in the United States (Bloomston, Nields, & Rosemurgy, 2003). The cost of treating GERD has been estimated to be $24.1 billion annually (Richter, 2000). By 2020, more than 16% of the population in the United States is expected to be older than 65 years while nearly 20 million will be older than 85 years (Hazzard, 2001). In the elderly, the prevalence of GERD is nearly the same among the general population, but complicated GERD appears to be more common than in younger people (Hazzard, 2001). Several authors have reported a higher incidence of esophagitis as well as Barrett esophagus in older patients (Fass et al., 2000; Grant et al., 2013; Reynolds, 1996; Shaheen & Ransohoff, 2002; Targarona et al., 2013). Surgical correction of GERD has been shown to be a cost-effective treatment by reducing long-term
TABLE 8. Questionnaire for Quality of Life (B) Yes
No
Did you have gastroesophageal reflux after the operation?
0%
100%
Have you receive antacid after the operation?
17.4%
82.6%
Has your everyday life improved?
91.3%
8.7%
Has your quality of life improved?
91.3%
8.7%
complications such as Barrett’s esophagus and stricture. Also, surgical therapy for GERD is eliminating the need of a life-long medical therapy especially for young patients (Comay et al., 2008; Pizza et al., 2007). Indeed, in our research, the mean of the cost of treatment was 2,876.3757 euros ($11,368.10 US) and the percentage of fever and nausea was 4.3% and 19.6%, respectively. Additionally, 82.6% of the patients discontinued antacid medications, thus minimizing overall costs (Epstein, Bojke, & Sculpher, 2009; Kamolz et al., 2002; Kornmo & Ruud, 2008). Hence, the shorter hospitalization, cost-effective surgical procedure, and the minimal use of antacids suggest LNF is an elective surgery that offers satisfaction to the patients and cost-effectiveness to the national health system. Transient dysphagia occurred in 40%–70% of patients after Nissen fundoplication. This is thought to be secondary to edema at the gastroesophageal junction or transient esophageal dysmotility. Fortunately, dysphagia usually resolves spontaneously within 2–3 months. Persistent dysphagia (PD), however, occurs in 3%–24% of patients after Nissen fundoplication (Singhal et al., 2009). Two years after our study, only 26.1% (N = 12) of the patients had occasionally mild dysphagia to solid and 17.4% (N = 8) had mild dysphagia to liquids. Patients often complained of bloating, a reduced ability to expel flatulence. In the follow-up, 50% (N = 13) of our patients did not have flatulence and only 21.7% (N = 10) of the patients had this symptom quite often. Furthermore, symptoms such as early satiety, dysphagia, and eructation have been reduced according to earlier reports (Balsara, Shah, & Hussain, 2008; Baraket et al., 2009; Martinez, Gonzalez, Punal Rodriguez, & Bustamante Montalvo, 2011; Nessen, Holcomb, Tankinson, Hetz, & Schreiber, 1999; Sato et al., 2002; Servio, de Camargo Pereira, & Cataneo, 2012; Singhal et al., 2009). Although follow-up has not exceeded 30 months, the clinical results are promising. Kamolz et al. (2002) found that LNF significantly improved patients’ quality of life during 5 years after surgery and patients’ satisfaction with surgical treatment was high (Sato et al., 2002; Singhal et al., 2009). These data support our report, where 91.3% (N = 42) of the patients treated with LNF declared substantial improvement in their everyday quality of life.
Conclusion Laparoscopic Nissen fundoplication was an effective long-term treatment for GERD. The operation resulted in a significant reduction of symptoms and minimized the use of antacid drugs with a high degree of patient satisfaction. Although some patients may have returned to antacid treatment at late follow-up or continued to complain of mild discomfort, they were overall pleased with the outcome of LNF. Despite the small number of
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patients treated, this study shows promising results regarding the effect of LNF on the long-term quality of life in patients with GERD.✪
REFERENCES Altun, H., Akyüz, U., Banli, O., Karakoyun, R., Onur, E., Okuducu, M., … Memıs¸og˘lu, K. (2012). The effect of narrowed segment length on the degree of early postoperative dysphagia in laparoscopic Nissen fundoplication. The Turkish Journal of Gastroenterology, 23(6), 676–680. Anvari, M., & Allen, C. (1998). Laparoscopic Nissen fundoplication: two-year comprehensive follow-up of a technique of minimal paraesophageal dissection. Annals of Surgery, 227(1), 25–32 Balsara, K. P., Shah, C. R., & Hussain, M. (2008). Laparoscopic fundoplication for gastroesophageal reflux disease: An 8 year experience. Journal of Minimal Access Surgery, 4(4), 99–103 Baraket, O., El Ajmi, M., & Rezgui, H., El Kateb, F., Chouchene, A., Khouni, H., & Balti, H. (2009). Laparoscopic treatment of gastroesophageal reflux: A review of 51 cases. La Tunisie Medicale, 87(8), 521–524 Bloomston, M., Nields, W., & Rosemurgy, A. S. (2003). Symptoms and antireflux medication use following laparoscopic Nissen fundoplication: Outcome at 1 and 4 years. Journal of the Society of Laparoendoscopic Surgeons, 7, 211–218 Comay, D., Adam, V., da Silveira, E. B., Kennedy, W., Mayrand, S., & Barkun, A. N. (2008). The Stretta procedure vs proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: A cost-effectiveness analysis. Canadian Journal of Gastroenterology, 22(6), 552–558 Epstein, D., Bojke, L., & Sculpher, M. J. (2009). Laparoscopic fundoplication compared with medical management for gastro-esophageal reflux disease: Cost effectiveness study. BMJ, 338, b2576 Fass, R., Pulliam, G., Johnson, C., Garewal, H. S., Garewal, H. S., & Sampliner, R. E. (2000). Symptom severity and oesophageal chemosensitivity to acid in older and young patients with gastrooesophageal reflux. Age and Ageing, 29, 125–130. Grant, A., Boachie, C., Cotton, S., Faria, R., Bojke, L., Epstein, D. M., ... Campbell, M. K. (2013). Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial). Health Technology Assessment, 17(22), 1–166 Hazzard, W. R. (2001). Demographic peristalsis. Implications of the age wave for gastroenterologists. Gastroenterology Clinics of North America, 30, 297–311, vii. Kamolz, T., Bammer, T, Wykypiel, H., Pasiut, M., & Pointner, R. (2000). Quality of life and surgical outcome after laparoscopic Nissen and Toupet fundoplication: One-year follow-up. Endoscopy, 32, 363–368. Kamolz, T., Granderath, P. A., Bammer, T., Pasiut, M., Wykypiel, H., Jr, Herrmann, R., & Pointner, R. (2002). Mid- and long-term quality of life assessments after laparoscopic fundoplication and refundoplication: A single unit review of more than 500 antireflux procedures. Digestive and Liver Disease, 34, 470–476 Kornmo, T. S., & Ruud, T. E. (2008). Long-term results of laparoscopic Nissen fundoplication due to gastroesophageal reflux
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disease. A ten year follow-up in a low volume center. Scandinavian Journal of Surgery, 97, 227–230 Locke, G. R., III Talley, N. J., Fett, S. L., Zinsmeister, A. R., & Melton, L. J. III (1997). Prevalence and clinical spectrum of gastroesophageal reflux: A population-based study in Olmsted County, Minnesota. Gastroenterology, 112, 1448–1456. Martinez, L. L., Gonzalez, P. P., Punal Rodriguez, J. A., & Bustamante Montalvo, M. (2011). Role of laparoscopic surgery in the treatment of achalasia: An analysis of 50 cases. Cirugia Espanola, 89(10), 657–662 Nessen, S. C., Holcomb, J., Tankinson, M. B., Hetz, S. P., & Schreiber, M. A. (1999). Early laparoscopic Nissen fundoplication for recurrent reflux esophagitis: A cost-effective alternative to omeprazole. Journal of the Society of Laparoendoscopic Surgeons, 3, 103–106 Nissen, R. (1961). “Gastropexy” and “fundoplication” in surgical treatment of hiatal hernia. The American Journal of Digestive Diseases, 6(10), 954–961 Pizza, F., Rossetti, G., Limongelli, P., Del Genio, G., Del Genio, G., Maffettone, V., … Del Genio, A. (2007). Influence of age on outcome of total laparoscopic fundoplication for gastroesophageal reflux disease. World Journal of Gastroenterology, 13(5), 740–747 Rattner, D. W. (2000). Measuring improved quality of life after laparoscopic Nissen fundoplication. Surgery, 127, 258–263. Reynolds, J. C. (1996). Influence of pathophysiology, severity, and cost on the medical management of gastroesophageal reflux disease. American Journal of Health-System Pharmacy, 53, S5–S12. Richter, J. E. (2000). Gastroesophageal reflux disease in the older patient: Presentation, treatment, and complications. The American Journal of Gastroenterology, 95, 368–373. Sato, K., Awad, Z. T., Filipi, C. J., Selima, M. A., Cummings, J. E., Fenton, S. J., & Hinder, R. A. (2002). Causes of long-term dysphagia after laparoscopic Nissen fundoplication. Journal of the Society of Laparoendoscopic Surgeons, 6, 35–40 Schietroma, M., De Vita, F., Carlei, F., Leardi, S., Pessia, B., Sista, F., & Amicucci, G. (2013). Laparoscopic floppy Nissen fundoplication: 11-year follow-up. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques, 23(3), 281–285 Servio, T. C., de Camargo Pereira, R. S., & Cataneo, D. C. (2012). Study on functional cardiorespiratory changes after laparoscopic Nissen fundoplication. Acta Cirurgica Brasileira, 27(7), 499–504 Shaheen, N, & Ransohoff, D. F. (2002). Gastroesophageal reflux, Barrett esophagus, and esophageal cancer: Clinical applications. JAMA, 287, 1982–1986 Singhal, T., Balakrishnan, S., Hussain, A., Grandy- Smith, S, Paix, A., & El-Hasani, S. (2009). Management of complications after laparoscopic Nissen’s fundoplication: A surgeon’s perspective. Annals of Surgical Innovation and Research, 3, 1 Targarona, E. M., Grisales, S., Uyanik, O., Balague, C., Pernas, J. C., & Trias, M. (2013). Long-Term outcome and quality of life after laparoscopic treatment of large paraesophageal hernia. World Journal of Surgery, 37(8), 1878–1882 Wahlqvist, P. (2001). Symptoms of gastroesophageal reflux disease, perceived productivity, and health-related quality of life. The American Journal of Gastroenterology, 96(8, Suppl.), 557S–561S.
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The Impact of Laparoscopic Nissen Fundoplication on the Long-Term Quality of Life in Patients With Gastroesophageal Reflux Disease ABSTRACT Laparoscopic Nissen fundoplication is now the most common surgical procedure for treatment of gastroesophageal reflux disease (GERD), offering promising long-term outcomes. Outcomes for 46 patients with GERD who underwent Nissen fundoplication during the last 5 years (November 2007–June 2012) were prospectively studied using a structured questionnaire that evaluated clinical symptom scores for heartburn, dysphagia, and satisfaction with clinical outcomes. Postoperative care of the patients including analgesia, median hospital stay, overall cost, and complications was also studied. Clinical follow-up data for 2 years after surgery were available for all 46 patients. Forty-two patients (91.3%) were satisfied with their quality of life and only eight patients (17.4%) continued to receive antacids after surgery. Dysphagia to solid and liquid occasionally appeared in 26.1% (N = 12) and 17.4% (N = 8) of patients, respectively. Laparoscopic Nissen fundoplication was an effective long-term treatment for GERD. The operation resulted in a significant reduction of symptoms and minimized the use of antacid drugs with a high degree of patient satisfaction. Although some patients may have returned to antacid treatment at late follow-up or continued to complain of mild discomfort, they were overall pleased with the outcome.
Received February 8, 2013; accepted October 29, 2013. About the authors: Dimitrios P. Korkolis, PhD, MD, is Consultant Surgeon, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Maria Kapritsou, MSc, BSN, RN, is Nurse, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece, and National and Kapodistrian University of Athens, Athens, Greece. Evangelos A. Konstantinou, PhD, RN, is Assistant Professor of Nursing Anesthesiology, National and Kapodistrian University of Athens, Athens, Greece. Margaret Giannakopoulou, PhD, RN, is Assistant Professor, National and Kapodistrian University of Athens, Athens, Greece. Maria S. Chrysi, MSc, RN, is Nurse, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Maria Tsakiridou, RN, is Head Chief Nurse of Surgical Clinic, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece.
VOLUME 38 | NUMBER 2 | MARCH/APRIL 2015
Andriana Kouloura, MD, is Resident in Surgery, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Matthaios Flamourakis, MD, is Resident in Surgery, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Mariantonietta Maricosu, MD, is Resident in Surgery, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. Emmanuil Gontikakis, PhD, MD, is Director of Surgical Clinic, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. George Plataniotis, MD, is Director of Surgical Clinic, Hellenic Anticancer Institute, “Saint Savvas” Hospital, Athens, Greece. The authors declare no conflicts of interest. Correspondence to: Konstantinou A. Evangelos, RN, BSN, MSc, PhD, Nursing Anesthesiology, National and Kapodistrian University of Athens, Athens, Greece ([email protected]). DOI: 10.1097/SGA.0000000000000097
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The Impact of Laparoscopic Nissen Fundoplication on Patients With GERD
Introduction The invention of the video laparoscope has recently changed the field of the modern surgery. Complex surgical procedures can be performed laparoscopically, with minimal disruption of patients’ life and a remarkable reduction in postoperative pain (Altun et al., 2012). Gastroesophageal reflux disease (GERD) is a common condition in which the lower esophageal sphincter allows gastric acids to reflux into the esophagus. Symptoms such as heartburn, regurgitation, dysphagia, and chronic lung disease may occur. Damage to the esophageal mucosa may result in severe esophagitis, ulceration, strictures, or Barrett’s esophagus (Locke, Talley, Fett, Zinsmeister, & Melton, 1997). Since fundoplication was reported by Rudolf Nissen in 1956, this procedure or modifications of it have become widely accepted for the surgical management of GERD with a long-term relief of symptoms in more than 90% of patients (Anvari & Allen, 1998). Laparoscopic Nissen fundoplication (LNF) is well established as an effective surgical therapy for the treatment of GERD, yielding substantial symptomatic improvement and reduction in the use and cost of antacid medications (Altun et al., 2012; Kamolz, Bammer, Wykypiel, Pasiut, & Pointner, 2000; Locke et al., 1997; Rattner, 2000; Wahlqvist, 2001). In a fundoplication, the gastric fundus (upper part) of the stomach is wrapped, or plicated, around the lower end of the esophagus and stitched in place, reinforcing the closing function of the lower esophageal sphincter. The esophageal hiatus is also narrowed down by sutures to prevent or treat concurrent hiatal hernia in which the fundus slides up through the enlarged esophageal hiatus of the diaphragm (Anvari & Allen, 1998; Nissen, 1961; Schietroma et al., 2013).
marked. Finally, the cost of the surgery that is referred to as the cost of surgical instruments was presented. All surgeries were performed by the same surgical team (D.P.K., E.G., and G.P.). Statistical analysis was initiated using SPSS 18 (IMB SPSS Software, Chicago, Illinois) and compared the above mentioned parameters. The data were expressed as mean ± SD. Data was retrieved for the literature review from the databases PubMed, MEDLINE, and Google Scholar. Studies with qualitative and quantitative orientation were included. Sixty-three studies were identified evaluating outcomes of LNF.
Results Demographic Data The demographic data of the patients who have undergone LNF are shown in Table 1. The cause of hospitalization is shown in Table 2.
Postoperative Recovery The average time for early activity was 1.22 days (range = 1–2 days), whereas return to regular diet was 1.57 days (range, 1–3). The total hospitalization period after LNF was an average of 4 days, (range, 2–17 days). Perioperative antibiotics were administrated for an average of 1.61 days (range, 1–4 days). Intravenous liquids were given for an average of 1.83 days (range, 1–4 days) (Table 3).
Fever and Nausea Just over four percent of the patients (N = 2) developed fever during the first postoperative day, whereas nine of the patients (19.56%) complained for some nausea or vomiting.
Methods This study was conducted at the Hellenic Anticancer Institute “Saint Savvas” Hospital, Athens, Greece. The protocol has been approved by the Scientific Committee of Hellenic Anticancer Institute “Saint Savvas” Hospital. All 46 consecutive patients suffering from GERD were treated with LNF from November 2007 to June 2010 and were prospectively followed up for 2 years after the operation to evaluate the long-term outcomes. Outcome measures included a questionnaire about symptoms such as dysphagia to solid or liquids, the use of antacids, and improvement of their everyday quality of life. Furthermore, the parameters such as gender, age, diagnosis of illness, postoperative analgesia, day of mobilization, and day of starting normal diet were calculated. Likewise, information was assembled on the total of days of intravenous administration of liquids and antibiotics. The complications were 112 Copyright © 2015 Society of Gastroenterology Nurses and Associates
TABLE 1. Patient Characteristics Laparoscopic Nissen Fundoplication
N = 46
Age at surgery (years) 20–29
4 (8.7%)
30–39
2 (4.3%)
40–49
10 (21.7%)
50–59
10 (21.7%)
60–69
12 (26.1%)
70–79
8 (17.4%)
Gender Male
22 (47.8%)
Female
24 (52.2%)
Gastroenterology Nursing
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TABLE 2. Cause of Hospitalization Laparoscopic Nissen Fundoplication
N = 46
Barrett’s esophagus
8 (17.4%)
Gastroesophageal reflux disease
24 (52.2%)
Hiatal hernia
14 (30.4%)
TABLE 3. Postoperative Recovery Parameters
Laparoscopic Nissen Fundoplication (n = 46)
Early activity (days)
1.20 ± 0.443
Time to resume regular diet (days)
1.57 ± 0.583
Length of stay (days)
4 ± 3.565
Antibiotics (days)
1.61 ± 0.829
Intravenous liquids (days)
1.83 ± 0.926
TABLE 5. Analgesia of First Postoperative Day
Analgesia
Laparoscopic Nissen Fundoplication (n = 46)
No analgesia
47.8%
Pethidine
4.3%
Paracetamol
4.3%
Tramadol
8.7%
Paracetamol + Codeine
4.3%
Paracetamol + dextropropoxyphene hydrochloride
26.1%
Dextropropoxyphene hydrochloride
4.3%
Cost of Surgery The cost of the surgery primarily includes the cost of surgical tools. The surgical cost for the LNF group was an average of 2,876.3757 euros ($11,368.10 US) (range, 850.45–7,030.74 euros [$963.12–$6207.17]).
Analgesia Postoperative analgesia was determined during the day of the surgery as well as the first and second postoperative days. Table 4 shows that 21.7% (N = 10) of the patients did not feel any pain during the day of the surgery whereas 69.6% (N = 32) of the patients complained for a moderate/mild pain. In the first postoperative day, 47.8% (N = 22) of the patients did not receive any painkillers, whereas only the 4.3% (N = 2) patients received drugs for intense and persistent wound pain (Table 5). In the second postoperative day, 91.3% (N = 42) of the patients had no pain at all (Table 6).
TABLE 4. Analgesia of the Day of the Surgery Surgical Analgesia
Laparoscopic Nissen Fundoplication (n = 46)
Morphine
4.3%
Pethidine + paracetamol
4.3%
Paracetamol
30.4%
Tramadol
4.3%
Tramadol + paracetamol
4.3%
Paracetamol + dextropropoxyphene hydrochloride
26.1%
Paracetamol + dextropropoxyphene hydrochloride + tramadol
4.3%
No analgesia
21.7%
Long-Term Quality of Life Patients were seen at the clinic every 3 months for 2 years after the surgery. At the visit, patients were asked to complete a questionnaire designed to assess patient satisfaction, medication use, and symptoms. Patients who did not return for follow-up received questionnaires by mail or were contacted by telephone. Patients were asked to mention how often they have symptoms such as dysphagia to solid and liquids, early satiety, and eructation. The questionnaire also asked patients to bring up whether they had gastroesophageal reflux symptoms again or had to receive antacid medications again after the surgery by marking either a ‘yes’ or ‘no’ answer. Finally, patients were asked whether or not they were pleased with their everyday life and their quality of life—whether the symptoms of GERD were diminished or they no longer existed— after the surgery with a simple ‘yes’ or ‘no’. Two years after the surgery, the entire series of patients returned identical questionnaires and their responses at that point in time.
TABLE 6. Analgesia of Second Postoperative Day Analgesia
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Laparoscopic Surgery (n = 48)
No analgesia
91.3%
Paracetamol + dextropropoxyphene hydrochloride
4.3%
Paracetamol + codeine
4.3%
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TABLE 7. Questionnaire for Quality of Life (A) Not At All
Occasionally
Quite Often
Often
Dysphagia to solids
65.2%
26.1%
4.3%
4.3%
Dysphagia to liquids
82.6%
17.4%
0%
0%
Early satiety
30.4%
39.1%
21.7%
8.7%
Flatulence
43.5%
52.2%
4.3%
0%
Vomiting
82.6%
17.4%
0%
0%
Diarrhea
73.9%
26.1%
0%
0%
Eructation
47.8%
52.2%
0%
0%
Overall, 42 respondents (91.3%) were satisfied with the operative experience at the time of followup because of the improvement of their everyday life, while 65.2% (N = 30) and 82.6% (N = 38) of the patients did not have dysphagia to solid and liquids anymore (Tables 7 and 8).
Discussion Gastroesophageal reflux disease is a common disorder in the western population; periodically, symptoms occur in approximately 20% of adults in the United States (Bloomston, Nields, & Rosemurgy, 2003). The cost of treating GERD has been estimated to be $24.1 billion annually (Richter, 2000). By 2020, more than 16% of the population in the United States is expected to be older than 65 years while nearly 20 million will be older than 85 years (Hazzard, 2001). In the elderly, the prevalence of GERD is nearly the same among the general population, but complicated GERD appears to be more common than in younger people (Hazzard, 2001). Several authors have reported a higher incidence of esophagitis as well as Barrett esophagus in older patients (Fass et al., 2000; Grant et al., 2013; Reynolds, 1996; Shaheen & Ransohoff, 2002; Targarona et al., 2013). Surgical correction of GERD has been shown to be a cost-effective treatment by reducing long-term
TABLE 8. Questionnaire for Quality of Life (B) Yes
No
Did you have gastroesophageal reflux after the operation?
0%
100%
Have you receive antacid after the operation?
17.4%
82.6%
Has your everyday life improved?
91.3%
8.7%
Has your quality of life improved?
91.3%
8.7%
complications such as Barrett’s esophagus and stricture. Also, surgical therapy for GERD is eliminating the need of a life-long medical therapy especially for young patients (Comay et al., 2008; Pizza et al., 2007). Indeed, in our research, the mean of the cost of treatment was 2,876.3757 euros ($11,368.10 US) and the percentage of fever and nausea was 4.3% and 19.6%, respectively. Additionally, 82.6% of the patients discontinued antacid medications, thus minimizing overall costs (Epstein, Bojke, & Sculpher, 2009; Kamolz et al., 2002; Kornmo & Ruud, 2008). Hence, the shorter hospitalization, cost-effective surgical procedure, and the minimal use of antacids suggest LNF is an elective surgery that offers satisfaction to the patients and cost-effectiveness to the national health system. Transient dysphagia occurred in 40%–70% of patients after Nissen fundoplication. This is thought to be secondary to edema at the gastroesophageal junction or transient esophageal dysmotility. Fortunately, dysphagia usually resolves spontaneously within 2–3 months. Persistent dysphagia (PD), however, occurs in 3%–24% of patients after Nissen fundoplication (Singhal et al., 2009). Two years after our study, only 26.1% (N = 12) of the patients had occasionally mild dysphagia to solid and 17.4% (N = 8) had mild dysphagia to liquids. Patients often complained of bloating, a reduced ability to expel flatulence. In the follow-up, 50% (N = 13) of our patients did not have flatulence and only 21.7% (N = 10) of the patients had this symptom quite often. Furthermore, symptoms such as early satiety, dysphagia, and eructation have been reduced according to earlier reports (Balsara, Shah, & Hussain, 2008; Baraket et al., 2009; Martinez, Gonzalez, Punal Rodriguez, & Bustamante Montalvo, 2011; Nessen, Holcomb, Tankinson, Hetz, & Schreiber, 1999; Sato et al., 2002; Servio, de Camargo Pereira, & Cataneo, 2012; Singhal et al., 2009). Although follow-up has not exceeded 30 months, the clinical results are promising. Kamolz et al. (2002) found that LNF significantly improved patients’ quality of life during 5 years after surgery and patients’ satisfaction with surgical treatment was high (Sato et al., 2002; Singhal et al., 2009). These data support our report, where 91.3% (N = 42) of the patients treated with LNF declared substantial improvement in their everyday quality of life.
Conclusion Laparoscopic Nissen fundoplication was an effective long-term treatment for GERD. The operation resulted in a significant reduction of symptoms and minimized the use of antacid drugs with a high degree of patient satisfaction. Although some patients may have returned to antacid treatment at late follow-up or continued to complain of mild discomfort, they were overall pleased with the outcome of LNF. Despite the small number of
114 Copyright © 2015 Society of Gastroenterology Nurses and Associates
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patients treated, this study shows promising results regarding the effect of LNF on the long-term quality of life in patients with GERD.✪
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