Complication
Early
Late
Death
0.09
0.001
Conversion to open
0–10 %
Reoperation
<0.1 %
3–10 %
Side effects (dysphagia, bloating, nausea, etc.)
20–60 %
5–10 %
The rate of conversion from laparoscopic to open is similar to that of other disciplines. A 10-year randomized trial conducted by Broeders et al. reported a rate of 7.6 % [27], similar to a rate of 7.3 % cited in a meta-analysis by Catarci et al. [28], and a rate of 6.3 % reported by Peters et al. [22] in a meta-analysis of RCTs. These rates fall in line with those reported nationally for conversion from laparoscopic to open cholecystectomy (5–10 %) [29] and for laparoscopic hysterectomy (0–19 %, mean 3.5 %) [30].
Mortality rates are low for antireflux surgery, even more so for laparoscopic procedures (0.2 % open versus 0.09 % LARS) [28]. The failure rate of laparoscopic fundoplication at 5 years follow-up is reported at 5–13 %, depending on whether failure is defined by subjective symptomatic failure or objective evidence [20].
Long-Term Outcomes of Laparoscopic Antireflux Surgery
Although studies show that the short-term outcomes of laparoscopic antireflux surgery (LARS) for the treatment of GERD are good, the long-term results are variable. LNF provides effective management of reflux symptoms, achieving long-term relief including heartburn and regurgitation in 84–97 % of patients [20]. Recent data demonstrates excellent heartburn and regurgitation control 5 years after standardized laparoscopic Nissen fundoplication [31] (Figs. 24.1 and 24.2). After 10 years, control of reflux symptoms was observed in 89.5 % of LNF patients, with PPI antacid medications being used by only 8.4 % of patients [32]. Long-term outcomes from the University of Washington revealed that the majority of patients showed a maintained improvement or resolution of symptoms including heartburn (90 %), regurgitation (92 %), and dysphagia (75 %) at 69 months, however lesser improvements were observed with symptoms of hoarseness (69 %) and cough (69 %) [33].
Fig. 24.1
Five-year outcomes of standardized laparoscopic Nissen fundoplication showing excellent durability. Data adapted from the LOTUS trial [31]
Fig. 24.2
Comparison of control of typical symptoms before and 5 years after laparoscopic Nissen fundoplication. Data adapted from the LOTUS trial [31]
A long-term post-surgical analysis conducted by Luostarinen et al. [34] found good results in patients 20 years after open antireflux surgery in most patients, with positive outcomes dependent on the condition of the fundic wrap. A reflux symptom resolution rate of 60 % was reported, with the incidence of dysphagia and heartburn being directly correlated with defective wraps, which were found in 28 % of patients [34] (Table 24.2).
While short-term outcomes of LARS are good, with an average of 85–95 % of patients experiencing excellent control of GERD symptoms [36, 37], long-term evidence suggests that these benefits diminish over time [3, 4]. A study evaluating LARS outcomes found better results at 5 years with resolution of significant reflux symptoms in 93 % of the patients, while at 10 years, 89.5 % of the patients were symptom free [32]. Valiati et al. [24] similarly revealed a short-term reflux recurrence rate of 3–4 % within 2 years of laparoscopic fundoplication, and 8 % long-term rate within 7 years.
Dysphagia
In an effort to provide the necessary structural integrity, the crural closure and fundoplication wrap procedure tightens the carida, which can result in dysphagia in some patients. Rates of dysphagia are variably reported (0–24 % in first few months post-surgery) and generally decrease with time (3–5 % long-term follow-up) [24]. A long-term study of LARS by Oelschlager et al. [33] concluded that after a median follow-up of 69 months, dysphagia symptoms were improved in 78 % of patients and resolved in 67 %. When medical treatment is compared, an RCT comparing esomeprazole to LARS reported symptoms at 5 year of 5 and 11 % for dysphagia, and 28 and 40 % for bloating (for the esomeprazole and LARS groups respectively) [38].
Although not statistically significant, the incidence of postoperative dysphagia was found to be greater in patients who had poorly controlled reflux and regurgitation. Data from multiple long-term studies from a literature review by Valiati et al. [24] summarized that the rate of persistent dysphagia is approximately 2–8 %. The occurrence of dysphagia is related to the type of fundoplication procedure, with total fundoplication associated with higher incidence rates. Surgeon experience is also thought to play a role in the prevalence of the complication.
Heartburn, Regurgitation, and Bloating
Long-term relief of heartburn and regurgitation can be achieved with laparoscopic fundoplication in 84–97 % of patients [20, 39]. A long-term study of LARS indicated that after a median follow-up of 69 months, heartburn symptoms were improved in 90 % of patients and resolved in 67 % [33]. A longer-term study with 10-year follow-up reported the percentage of patients with no or mild heartburn as 94.9 % following LNF [27].
Comparison of medical treatment to LARS for the management of reflux symptoms results in good control in both groups. A randomized trial comparing esomeprazole to LARS reported GERD symptoms at 5 years follow-up of: 16 and 8 % for heartburn, 13 and 2 % for acid regurgitation (for the esomeprazole and LARS groups, respectively) [38]. Heartburn free days were calculated in a randomized controlled trial comparing LNF to medical therapy (PPIs). The surgical group improved significantly with a mean of 1.35 more heartburn free days per week than the medical group (95 % CI) [40]. A study of 288 LARS patients revealed patients had considerably improved symptoms of regurgitation, with improvement in 92 % of patients at 5 years follow-up, and resolution in 70 % [33].
Reported incidence of gas bloating, abdominal distension, and flatulence are common following fundoplication. During a 10-year study of LARS, Dallemagne et al. [32] found the rate of flatulence decreased significantly over time, but abdominal distension and bloating increased with time. Valiati et al. [24] also report a steady increase in gas bloating and epigastric pain over time with a rate of 2.2 and 2.8 % <2 years and 3.9 and 4.9 % at >2 years.
Patient Satisfaction
Patient-reported outcomes assess the patient’s experience and are reported in terms of health-related quality of life, current health state, and patient satisfaction. A high rate of patient satisfaction is reported following laparoscopic fundoplication, ranging from 80 [31] to 96.5 % [20]. A randomized trial found a high satisfaction rate for LARS of 90 % [20], similarly, a 15 year RCT found a rate of 91.7 % [75].
When surgical treatment is compared to pharmacological therapy, an RCT using the VAS score to report overall patient satisfaction found significant improved symptom control at 3 years for the surgical group, whereas the medical group reported maintained scores (82.60–81.95 for the PPI group versus 81.79–92.67, P = 0.0072 for the LNF group) [39]. Contini and Scarpignato [41] highlight that patient satisfaction is correlated with improvement in quality of life and resolution of symptoms, while the use of antireflux medication does not influence the rate of satisfaction significantly. Broeders et al. [27] found that quality of life scores increased following LNF with a mean increase of 25.8 % at 10 years. It is understood that numerous patient-related factors can contribute to and affect quality of life and satisfaction scores following LARS, however subjective degree of symptoms is not a reliable indicator of objective reflux.
Antireflux Medication Utilization Following Surgery
The use of PPIs is the primary treatment for GERD [42], however many patients still experience recurrent symptoms, with a failure rate of up to 40 % [43]. The need for antireflux medication following fundoplication is often used as an outcome measure for success. Some studies show an increase of acid-suppressing medication use following antireflux surgery to a rate of 15–22 % [24, 27, 44–47].
Conversely, some long-term trials have found a large percentage of LNF patients achieving relief of reflux symptoms no longer requiring acid-suppressing medications (72.2 %) [27]. A study by Papasavas et al. [48] found the use of PPI medication decreased from 84.4 % preoperatively to 18.7 with 82.7 % free of routine pharmacological treatment (PPIs, H-2 receptor blockers, and antacids for GERD symptoms) at 2 years follow-up. Draaisma et al. [49] indicate similar results at 5 years follow-up, with 13.9 % LNF patients requiring continued use of antireflux medications.
The reasons for frequent use of antireflux medication postoperatively must be explored, as abnormal esophageal acid is not always correlated with postoperative pharmacotherapy [49–51]. Antireflux medications are frequently prescribed in our current health care system, for a variety of GI presentations. Salminen [20] found that although 18.7 % of patients were taking PPI medication at 2 years post-surgery, GERD symptoms scores, as assessed using the Jamieson symptom scoring system, revealed that 82 % of patients improved from severe to mild reflux symptoms. Papasavas et al. [48] found that at 2 years LNF, PPI therapy was required by 10 % of patients for typical GERD symptoms, and 8.7 % were using PPIs for other reasons, such as Barrett’s esophagus, “sensitive” stomach, and irritable bowel syndrome. A study by Oelschlager et al. [33] withdrew antireflux medications from post antireflux surgery patients for 2 weeks to investigate GERD symptoms, and found that symptoms did not change significantly during the absence of medication (as cited in Oelschlager et al. [33]). The use of pharmacotherapy for alternate or unnecessary reasons after fundoplication can distort results when outcomes of surgical failure are analyzed by medication use; therefore it is not an efficient measure for procedure efficacy.
Failure Rates and Reoperation
In some cases the fundoplication can unwrap or the sutured connection may become unsecured. Contributing factors of wrap displacement include insufficient adhesions, inadequate closure of the diaphragmatic crura, and a short esophagus and/or insufficient esophagus mobilization. Reoperation, when required, can be especially challenging, resulting in poorer outcomes than initial fundoplication.
A common outcome metric for the efficacy of antireflux surgery is the requirement of revisional surgery which occurs at a rate of around 3–7 %. A study at the University of Washington reports a reoperation rate of 3 % following LARS, for reasons of gastric perforation, acute herniation, and revision for chronic problems such as dysphagia or recurrent GERD [33]. A revision rate of 4 % was found in a study evaluating LARS 10 year’s post-surgery, attributed to recurrent reflux symptoms and persistent dysphagia [32]. Another study found that 2.8 % of patients required redo fundoplication, many due to mechanical failure of the wrap (61 % transdiaphragmatic wrap herniation) [52]. The second procedure was successful for 93 % of patients [52]. Higher rates of reoperation were found in a study by Kelly et al. [53] of LNF outcomes at 10 years, with surgical revision required for 17 % of patients (6 % for recurrent hiatus hernia, 6 % for dysphagia, 4 % for recurrent reflux, and 0.04 % for postoperative bleeding from a short gastric vessel).
The results of re-fundoplication are often inferior to those of the initial procedure. A study by Salminen et al. [54] reported a morbidity rate of 21 %, a mortality rate of 1.4 %, and reoperation rate of 16 % following fundoplication revision. Complications of re-fundoplication include recurrent hiatus hernia (70 % [55]) and hollow viscus injury (22 % [55], 21.8 % [52]). The level of surgical expertise and the need for proper patient selection are important factors for success not only for the initial surgery, but perhaps even more emphatically for re-intervention.
Comparing LARS to Long-Term PPI Therapy
For patients with severe GERD symptoms, medical management continues to be the first treatment, however, evidence suggests that symptom control should be re-evaluated, and LNF considered as an alternative or follow-up treatment for those with poor or moderate control. Uncertainty remains as to whether antireflux surgery is effective for treating patients with poor response to PPIs. A study by Anvari et al. [56] investigated patients with poorly and well-controlled GERD following laparoscopic fundoplication, finding that GERD patients who responded poorly to PPI therapy experienced significantly improved physical and mental health QoL scores following surgical intervention. The study confirmed that response to PPI therapy does not impact surgical treatment, and all patients should experience good results following laparoscopic fundoplication.
Randomized trials comparing antireflux surgery to optimized medical therapy have concluded LNF to be superior in terms of symptom control and quality of life. An RCT of 104 patients compared long-term, symptomatically stable, medically controlled patients to laparoscopic Nissen fundoplication [39]. All patients had chronic GERD symptoms requiring long-term therapy prior to enrollment, with a minimum of 1-year PPI therapy, with continued expected need. Greater improvement was shown in the surgical group with patients experiencing a mean of 1.35 more heartburn free days per week than medical management patients and a more significant improvement in symptom scores using the global visual analog scale (VAS) from a mean of 81.79 at baseline to 92.67 (P = 0.0072). Greater improvement was also found in Quality of life scores (Short Form 36) with a mean difference of −12.19 (P = 0.0124) at 3 years (Fig. 24.3) [39]. The study concluded that although similar GERD symptom scale results were found with both LNF and PPI therapy, surgical treatment offered benefits of an increase in heartburn free days, improved VAS score, and lowered the esophageal acid exposure to the normal range for this group [39].
The LOTUS trial evaluated optimized esomeprazole therapy compared to LARS in GERD patients across 11 European countries [31]. A total of 554 patients were randomized in this open, parallel-group trial, with 372 patients completing the 5-year follow-up [31]. Remission rates were evaluated at this time, defined as the need for acid suppressive therapy in the surgical group, and inadequate symptom control after dose adjustment in the medical group, and were reported as 92 % (95 % CI, 89–96 %) in the esomeprazole group and 85 % (95 % CI, 81–90 %) in the LARS group (P = 0.048) [31]. This study similarly to the Anvari and Allen trial [39] previously mentioned found a greater prevalence and severity of heartburn in the medical group with 16 % in the esomeprazole group and 8 % in the LARS (P = 0.14), as well as 13 and 2 % for acid regurgitation (P < 0.001) [31]. The medical group reported a lower incidence of dysphagia with 5 versus 11 % (P = 0.001), and slightly decreased rates of bloating and flatulence than the surgical group [31].
Evidence has shown that antireflux surgery is an effective treatment for patients with poor response to standard PPI treatment. A prospective randomized study of 183 patients, compared LNF and PPI therapy, and further explored the medically managed patients, offering LNF following 12 months of pharmacotherapy treatment [57]. Although both LNF and PPI therapy were found to provide effective long-term treatment of GERD, a cohort of patients (54 patients) in the medical arm achieved only moderate benefit and chose to undergo laparoscopic Nissen fundoplication. These patients experienced further relief from symptoms, with a mean DeMeester symptom score at baseline of 3.3, 2.3 at 12 months (with PPI therapy only) and 0.8 at a median of 6.9 years follow-up (post LNF) with a significant change in score from 12 months (P < 0.01) [57]. Similar findings were discovered in a trial evaluating the effectiveness of laparoscopic Nissen–Rossetti fundoplication in patients with GERD who are poorly responsive to standard PPI therapy. Thirty-five patients with persistent pathological esophageal acid and/or bilirubin exposure underwent LARS, and significant improvement was found in their symptom scores 1-year post-surgery when compared to standard PPI treatment [58].
Many studies correlate long-term PPI use with increased fracture risk. Although PPIs have a very favorable safety profile, potential long-term effects of chronic acid suppression on the absorption of vitamins and nutrients and increased occurrence of osteoporosis-related bone fractures are now raising concern and awareness [59]. While it has been proven that both optimal PPI therapy and laparoscopic Nissen fundoplication are effective treatments for GERD, surgery offers additional benefit for those who have only partial symptomatic relief from pharmacotherapy, and reduces any risk associated with long-term PPI use. Laparoscopic Nissen fundoplication has the potential to become an alternative long-term therapy for GERD, particularly in patients requiring extended use of PPIs.
Predictors of Success
The success of antireflux surgery depends heavily on patient selection. Patients with a good response to medical therapy without complicated disease have been shown to have superior outcomes following antireflux surgery [60, 61]. Patients who have been identified with clinical testing as having pathological acid reflux are more likely to respond well to surgical treatment than those with unknown or complicated diagnoses. Campos et al. [61] conducted a multivariate analysis to analyze predictive factors of LNF outcomes, finding three predictive factors of successful outcome: an abnormal 24-h pH score, the presence of typical symptoms of gastroesophageal reflux, and a significant improvement in symptoms with acid suppression therapy prior to surgery.
When predicting successful long-term outcomes of reflux surgery, sex, age, obesity, history of psychiatric illness and the presence of dysphagia pre-surgery are all indicators. Although symptoms of dysphagia often improve after fundoplication, the incidence of pre-surgical dysphagia negatively influences clinical outcome. Univariate regression analysis conducted by Oeschlager et al. [33] found that male patients, of younger age, presenting with heartburn, were much more likely to have successful outcomes of LARS, whereas preoperative dysphagia, airway manifestations, bloating, and defective esophageal motility were negative predictive factors. A study by Morgenthal et al. [62] found that preoperative morbid obesity (BMI > 35 kg/m2) was associated with LNF failure, while obesity was not (BMI 30–34.9 kg/m2). A history of psychiatric illness trended toward a failed outcome, but did not reach statistical significance (P = 0.06) [62]. Similarly a regression analysis completed by Irino et al. [63] concluded that a BMI > 25 kg/m2 and age >60 years were significant factors negatively affecting scores of postoperative GERD specific QOL.
Many authors have suggested clinical presentations of large hiatal hernias, atypical symptoms, the presence of Barrett’s esophagus and esophagitis, and a defective LES lead to increased failure rates and poor outcomes of fundoplication, though these opinions are not expressed consistently throughout the literature [19, 62]. Procedural variations such as division of the SGVs, degree of the wrap, and technology may play a minimal role in the success of surgical treatment (Table 24.3).
Table 24.3
Suggested factors affecting good outcomes of antireflux surgery
Predictor of positive outcome | Predictor of poor outcome |
---|---|
Good response to PPI | No response to PPI |
Typical symptoms | Atypical symptoms |
High volume practice | Low volume practice |
No/small Hiatal Hernia | Large Hiatal Hernia |
Male gender | Female gender |
No Barrett’s
Stay updated, free articles. Join our Telegram channelFull access? Get Clinical TreeGet Clinical Tree app for offline access |