Introduction

Achalasia is a rare esophagus disease that stands for the progressive absence of relaxation in the lower esophagus sphincter (LES), and the disease symptoms include dysphagia, heartburn, and chest pain [1]. The most common etiology of achalasia is idiopathic [2, 3]. It appears approximately in 1 case over 100,000 people, but recent studies have shown that this number is increasing over the last decade. Also, there was no difference in prevalence between gender and race [4,5,6]. Degeneration of nerves in the esophageal myenteric (Auerbach) neural plexus inhibits LES relaxation in achalasia disease [7]. Achalasia treatments are divided into surgical and non-surgical. Non-surgical treatments for achalasia are mostly drugs based on calcium channel blockers (CCB) and nitrates. These drugs induce relaxation in the soft muscle layer of the esophagus, but the treatment cannot cure the disease completely or improve the life quality of patients in long term [8]. Also, endoscopic injection of botulinum toxin into the esophagus muscle did not show any promising results [9]. The most common surgical treatment for achalasia is Heller myotomy invented by Ernest Heller in 1913 [10]. Laparoscopic Heller myotomy [LHM] shows a shorter operation time, decreased hospitalization, and cost-effectiveness over the traditional open Heller myotomy [11, 12]. Fundoplication was added to LHM surgery to reduce gastroesophageal reflux following the Heller myotomy. On one hand, LHM with fundoplication can relieve patients’ symptoms, but on the other hand, patients undergoing LHM with fundoplication may still suffer from GERD [13, 14]. In recent years, peroral endoscopic myotomy (POEM) was a challenging rival for LHM with fundoplication which showed promising results in recent studies [15, 16]. However, many studies have shown that POEM had a significantly higher rate of GERD than LHM with fundoplication postoperatively [15,16,17,18,19].

Achalasia can disturb physical, emotional, and social activities such as disturbed sleep, reduced vitality, generalized body pain, impaired sexual life, and anxiety [20]. Until now, there are several ways to evaluate the severity and progress of achalasia such as the Eckhart index [21]. Also, the GERD-HRQL questionnaire focuses on symptoms like heartburn, dysphagia, and bloating [22]. Much uncertainty still exists about the quality of life in patients with achalasia after LHM with fundoplication. So, it is vital to get explored more in future studies. Considering all the key points, LHM with fundoplication still is the most successful treatment in short term, so we aimed to assess the quality of life in patients with achalasia undergoing LHM with fundoplication after at least 6 months from surgery with GERD-HRQL questionnaire.

Patients and Methods

Study Population

This cohort study was conducted between 2014 and 2021 in the educational hospitals of Mashhad University of Medical Sciences in Mashhad, Iran. Fifty-four patients with achalasia who underwent endoscopic Heller myotomy surgery with fundoplication were enrolled in this study. Patients’ demographical data such as sex, age, and BMI were collected. All the patients signed informed consent before entering the study. The study was approved by the ethics committee of Mashhad University of Medical Sciences (IR.MUMS.MEDICAL.REC.1399.528). The inclusion criteria were at least 6 months passed from LHM with fundoplication surgery and the patient’s informed consent. The patients who did not cooperate with the research team had been excluded from the study.

Surgical Technique

By using 5-port access, laparoscopic Heller myotomy with Dor fundoplication was performed under general anesthesia. At 12–15 mm Hg, pneumoperitoneum was established. After the incision of the gastrohepatic ligament, a short anterior dissection was carried out for exposure of the crura, gastroesophageal junction, and vagus nerve. With the harmonic scalpel, an anterior myotomy with a 6-cm length was performed that extended 1.5 to 2 cm onto the stomach (Ethicon, Somerville, NJ). In the last stage of the operation, a fundoplication was performed securing the anterior fundic wall to both crura and the edges of the myotomy site.

Quality of Life Outcome Measures

We asked patients to fill out two standardized questionnaires: [1] a Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire (GERD-HRQL) validated by Velanovich [22] and [2] a five-point Likert scale for the severity of dysphagia (dysphagia score). Both questionnaires can be filled in an approximated time between 5 and 15 min. The GERD-HRQL focuses on symptoms like heartburn, dysphagia, and bloating that includes ten questions which every question score between 0 and 5. The total score range was between 0 and 50 which a completely asymptomatic patient had a score of 0, and the most severe symptomatic patient had a score of 50. The questionnaire included an extra question that asks whether patients are satisfied, dissatisfied, or neutral with their present condition (Fig. 1).

Fig. 1
figure 1

Original gastroesophageal reflux disease-health-related quality of life questionnaire

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Besides that, we assessed the dysphagia score with a five-point Likert scale (0 = none, 1 = ability to swallow some solids, 2 = ability to swallow some semi-solids, 3 = ability to swallow fluids, 4 = not able to swallow anything).

Statistical Analysis

Data analysis was performed using SPSS software version 26. Quantitative and qualitative variables were reported as mean + standard deviation and percentages respectively. Student’s t-tests or ANOVA were used for the comparison of quantitative variables. Qualitative variables were assessed by the chi-square test. The significance level was considered less than 0.05.

Results

A total of 54 patients underwent LHM with fundoplication. Eight patients were excluded because they did not give consent to participate in this study. Finally, 46 patients were enrolled in this study from 2013 to 2021. The mean ages of patients were 39.76 SD13.69, and 43.5% of them were men. The mean BMI (body mass index) was 23.66 SD4.49 kg/m2. The mean follow-up time for patients was 40.48 SD25.36 months after surgery (Table 1).

Table 1 Patient characteristics and follow-up time
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GERD-HRQL and Dysphagia Score

GERD-HRQL questionnaire was used to assess patients’ symptom severity. As shown in Table 2, the mean GERD-HRQL score was 18.00 SD5.67 and 6.91 SD3.81 before and after at least 6 months of the surgery, and the difference was statistically significant (P-value < 0.001). Also, subgroup analysis showed, in both men and women patients, the GERD-HRQL was significantly decreased after surgery. The mean GERD-HRQL score differences (before and after surgery) were − 11.08 SD6.42 in all patients, and as can be seen from Table 3, it is not significantly changed in different time intervals (P-value = 0.541).

Table 2 Pre-and post-operative GERD-HRQL score and dysphagia score
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Table 3 GERD-HRQL score and dysphagia score differences (post-operative score–pre operative score) in different time intervals
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Further analysis showed that the mean score for dysphagia was 3.67 SD0.47 and 1.20 SD0.91 before and after surgery respectively, and the difference was significant (P-value < 0.001). The score differences for dysphagia were − 2.46 SD1.03 in all patients, and it did not change significantly in different time intervals (P-value = 0.637) (Table 3).

Patients’ Satisfaction

Forty-one patients (89.1%) were satisfied with their present condition after surgery. In more detail, 100% of patients who underwent surgery in the past 6 to 12 months, 88.2% of patients who underwent surgery in the past 1 to 3 years, and 85.7% of patients who underwent surgery over the past 3 years were satisfied with their health and GERD conditions. The satisfaction rate was not significantly different between men and women.

Discussion

This study was designed to assess the quality of life in patients with achalasia after LHM with fundoplication. The surgical treatment for achalasia aims to improve patients’ quality of life and nutritional state, as well as to relieve patients from achalasia symptoms such as chest pain and dysphagia. Balancing these goals against the risk of inducing GERD following the surgery is necessary [23]. LHM was introduced as a choice treatment for achalasia, but it can predispose the patients to the post-operative GERD [24, 25]. It was reported that pathologic gastroesophageal reflux in 6 months after surgery can be found in 48% of patients that undergo LHM without anti-reflux surgery [26]. Hence, LHM in combination with anti-reflux surgery has been recommended in current guidelines, and it can cause a significant reduction of post-operative reflux (8.5–17%) [4, 27]. A recent clinical trial demonstrated that adding fundoplication after LHM can decrease the post-operative reflux rate from 48 to 9% [26]. However, it is notable that even with the combination of LHM and fundoplication, a considerable number of patients can still suffer from reflux [14]. Also, some studies showed that fundoplication can cause dysphagia, inability to belch, and early fullness [12].

In the present study, we used the GERD-HRQL questionnaire which allowed a more accurate evaluation of heartburn symptoms that other questionnaire does not consider, and patients are often confused with chest pain symptoms [28]. In this study, we found that the mean GERD-HRQL score was significantly lowered in patients who underwent LHM with fundoplication after at least 6 months of follow-up. Also comparing different time intervals showed that the GERD-HRQL score was not significantly changed through the time after the surgery. It was stated that the pre-operative GERD-HRQL score of 13.5 reduced to 2 after the Heller myotomy with the Dor fundoplication in achalasia patients [23]. Also, a retrospective observational study showed that the GERD-HRQL score in achalasia patients decreased after the LHM with fundoplication surgery [28]. Our results were consistent with a meta-analysis of 7855 patients demonstrating that LHM with fundoplication can decrease the incidence of post-operative GERD to 8.8% [29]. Furthermore, by present results, a recent study compared the LHM and LHM with fundoplication in 41 achalasia patients with 11.8 years of follow-up. It conclude that the long-term GERD-HRQL score was comparable in both LHM and LHM with fundoplication patients [30]. Also, another study examined 40 patients who underwent LHM with fundoplication by using disease-specific Gastrointestinal Quality of Life Index and showed the quality of life scores were mostly improved in patients with a lower preoperative score, indicating that a higher preoperative score can increase the risk of operation side effects such as reflux [31].

As mentioned earlier, dysphagia is a concern in patients who underwent fundoplication surgery. However, in the present study, the dysphagia score was significantly reduced after the surgery, and it did not change significantly in different post-operative time intervals. It can present the potential efficacy of LHM with fundoplication in achalasia patients. These results are consistent with results obtained from a previous study, where they found dysphagia and the Eckardt score were significantly reduced after LHM with partial fundoplication [14]. Furthermore, a study comparing LHM and LHM with the Dor fundoplication showed the dysphagia score was improved in both groups, and the difference was not significant. It also demonstrated that patients who underwent LHM with fundoplication have significantly less post-operative gastroesophageal reflux than LHM alone [26].

Finally, the present study suggests that laparoscopic Heller myotomy with fundoplication can be a choice treatment for patients with achalasia with high post-operative satisfaction. The reasonable time of follow-up and sample size, although achalasia is a rare disease, is the strength of this study. However, this study has some limitations. First, post-operative manometric and pH monitoring was missing. Second, the fact that GERD-HRQL questionnaire was not specifically designed for achalasia assessment. Future studies should be designed to compare different treatments for achalasia based on the validated quality of life tools.

Conclusion

In this study, we concluded that patients with achalasia undergoing laparoscopic Heller myotomy with fundoplication experience a significant improvement in quality of life with high satisfaction.