Gastroesophageal reflux disease (GERD) is a frequent chronic gastrointestinal disorder in which the reflux of gastric contents into the esophagus is troublesome, usually presenting as heartburn and regurgitation. Beyond the frequency of symptoms, its impact is felt in day-to-day functioning, dietary habits, sleep and health-related quality of life. A large systematic review and meta-analysis showed that there was a substantial prevalence of gastroesophageal reflux symptoms globally, but with significant geographic and population differences [1]. Thus, GERD is a significant clinical issue in both medical and surgical practice.

PPIs are the mainstay of pharmacologic therapy for GERD and are effective in controlling symptoms in many patients. However, a subset of patients still has persistent symptoms despite the best medical treatment, needs long-term medication, has complications from reflux or wants a definitive surgical procedure. Modern clinical guidelines thus consider antireflux surgery to be a viable option in carefully selected patients with objectively confirmed GERD, especially if long-term control is sought or medical treatment is not effective [2,3]. Randomized studies have also compared long-term medical treatment with laparoscopic antireflux surgery, demonstrating that both options can achieve long-term control of reflux in the appropriate patient population, thus establishing surgery as a valid therapeutic option [4].

One of the most widely studied surgical procedures for GERD has been Nissen fundoplication, which involves wrapping the gastric fundus 360° around the distal esophagus. The surgery was formerly done through an open abdominal approach, but laparoscopy changed the way surgery was done. Minimally invasive fundoplication was an option that would allow for less surgical trauma and quicker recovery after surgery, while still trying to maintain the antireflux properties of the traditional surgery. Initial randomized trials showed that laparoscopic surgery was as effective as open fundoplication in controlling reflux, but the rates of postoperative morbidity, dysphagia, operating time and recovery varied in the different trials [5-8]. These results highlighted the need to assess technical success, short-term recovery and patient-centered outcomes of the two approaches.

Recurrent reflux, reoperation, the need for acid-suppressive medication, dysphagia and gas-bloat symptoms may develop well after the initial postoperative period, especially after fundoplication. Randomized studies with follow-up of 5, 11, and 15 years have demonstrated that long-term symptom control can be achieved following both laparoscopic and open Nissen fundoplication, and that long-term results do not necessarily reflect differences seen during the early postoperative period [9-11]. This is clinically important: a technique that is less painful and has a shorter hospital stay does not necessarily lead to better long-term reflux control, and the success of the surgery should be evaluated by both clinical and patient-reported outcomes.

Health-related quality of life is an additional measure alongside traditional surgical outcomes. The Gastroesophageal Reflux Disease–Health Related Quality of Life (GERD-HRQL) instrument was developed to measure the severity and impact of reflux-related symptoms and has been used to evaluate the response to medical, endoscopic, and surgical treatments [12]. The addition of such a disease-specific measure to the other measures of recurrence, complications, medication, and reoperation provides a more complete assessment of the effectiveness of antireflux surgery.

While the laparoscopic technique is now popular, it is still important to compare the two techniques to understand the size and longevity of the benefits of minimally invasive access. Furthermore, the majority of the randomized evidence directly comparing these approaches was generated in the early stages of the evolution of laparoscopic antireflux surgery [5-11]. In settings where both surgical options can be evaluated under similar operative principles, evaluation of perioperative recovery, in addition to intermediate- to long-term symptom control and quality of life, is still useful.

The current randomized controlled trial was conducted to evaluate the long-term symptom control and health-related quality of life of laparoscopic and open Nissen fundoplication in GERD patients. Secondary comparisons were operative and early postoperative results, recurrent reflux, postoperative dysphagia and gas-bloat symptoms, continued use of acid-suppressive medication, readmission, and reoperation during 24–36 months of follow-up.

The study was a prospective randomized controlled trial carried out in the Department of Surgery at Veer Surendra Sai Institute of Medical Sciences and Research (VIMSAR) from January 2022 to January 2025. Patients were recruited from January 2022 to January 2023 and followed up until January 2025, thus obtaining approximately 24–36 months of postoperative follow-up.

Eighty adults with gastroesophageal reflux disease (GERD) were enrolled who were deemed appropriate for anti-reflux surgery. Patients who had prior anti-reflux surgery, significant upper gastrointestinal surgery, esophageal or gastric malignancy, severe esophageal motility disorders, contraindications to general anesthesia, pregnancy, or inability to comply with follow-up were excluded. All patients were clinically evaluated and underwent upper gastrointestinal endoscopy, while esophageal manometry and 24-hour pH monitoring were performed when clinically indicated. The GERD-Health Related Quality of Life (GERD-HRQL) questionnaire was used to measure baseline quality of life.

A computer-generated sequence was used to randomize patients in a 1:1 ratio to laparoscopic Nissen fundoplication (n=40) or open Nissen fundoplication (n=40). Sequentially numbered opaque sealed envelopes were used to conceal allocation. Both groups underwent a standard 360° Nissen fundoplication under general anesthesia, with similar operative principles, including mobilization of the distal esophagus, repair of the hiatus if necessary, and creation of a tension-free fundic wrap.

Operative time, intraoperative blood loss, complications, postoperative pain, time to oral intake, hospital length of stay, readmission, and reoperation were documented. Patients were followed at approximately 1, 3, 6, 12, and 24 months and then annually until January 2025. Recurrent heartburn or regurgitation, use of anti-reflux medication, dysphagia, gas-bloat symptoms, readmission, reoperation, and GERD-HRQL score were assessed during follow-up. The primary long-term quality-of-life outcome was the 24-month GERD-HRQL score.

Long-term symptom control and health-related quality of life at 24 months were the primary outcomes. Secondary outcomes were recurrent reflux, postoperative medication use, dysphagia, gas-bloat syndrome, operative and postoperative complications, hospital length of stay, readmission, and reoperation.

Continuous variables were presented as mean ± SD or median (interquartile range) and analyzed using the independent-samples t test or Mann–Whitney U test, respectively. The chi-square test or Fisher's exact test was used to compare categorical variables. Appropriate paired and repeated-measures analyses were used to assess changes in GERD-HRQL scores. A two-sided p value <0.05 was considered statistically significant, and analysis was performed according to the intention-to-treat principle.

The study was carried out following approval by the Institutional Ethics Committee of VIMSAR, and written informed consent was obtained from all participants.

Study population and baseline characteristics

Eighty patients were randomized, with 40 (50.0%) assigned to laparoscopic Nissen fundoplication and 40 (50.0%) to open fundoplication. The randomized groups were broadly comparable with respect to age, sex, BMI, comorbidities, hiatal hernia, esophagitis, predominant reflux symptoms, preoperative PPI use, and baseline GERD-HRQL score. The duration of GERD was longer in the laparoscopic group. Mean follow-up was 27.3 ± 3.1 months after laparoscopic surgery and 27.0 ± 2.9 months after open surgery (Table 1).

Operative and early postoperative outcomes

Laparoscopic fundoplication required a longer mean operative time but was associated with substantially lower blood loss, lower 24-hour pain scores, reduced analgesic requirement, earlier oral intake, and shorter hospital stay. One laparoscopic procedure required conversion to open surgery. Postoperative complications occurred in 2 (5.0%) laparoscopic and 8 (20.0%) open procedures; the difference did not reach statistical significance by Fisher exact testing (Table 2).

GERD-related quality of life

GERD-HRQL scores improved markedly after surgery in both groups and remained substantially below preoperative levels throughout follow-up (Figure 1). A lower mean score was observed in the laparoscopic group at 3 months, whereas scores were similar at 6, 12, and 24 months and at final follow-up (Table 3). Longitudinal generalized estimating equation analysis demonstrated a strong effect of time (Wald χ²=552.46, df=6, p<0.001) and a modest group-by-time interaction (Wald χ²=12.80, df=6, p=0.046).

By 24 months, mean GERD-HRQL improvement from baseline was 23.4 ± 6.5 points after laparoscopic surgery and 22.7 ± 8.4 points after open surgery. The magnitude of improvement remained comparable between groups at final follow-up.

Long-term symptom control and treatment success

Long-term reflux control was generally good in both groups. Recurrent GERD at final follow-up occurred in 2 (5.0%) patients after laparoscopic surgery and 4 (10.0%) after open surgery. Overall treatment success was achieved in 35 (87.5%) and 34 (85.0%) patients, respectively. Long-term PPI use, persistent dysphagia, gas-bloat symptoms, late readmission, and late reoperation were similar between groups (Table 4 and Figure 2).

Table 1. Baseline characteristics by randomized treatment group

Data are mean ± SD, median (IQR), or n (%) as appropriate. Welch's t test, Mann–Whitney U test, Pearson chi-square test, or Fisher exact test was used according to variable type and cell frequencies.

Table 2. Operative and early postoperative outcomes

Data are mean ± SD or n (%). Postoperative complications comprised transient dysphagia (n=1) and other minor complication (n=1) after laparoscopic surgery; open-surgery complications comprised wound infection (n=4), ileus (n=2), respiratory complication (n=1), and other minor complication (n=1).

Table 3. GERD-HRQL scores during follow-up

GERD-HRQL range 0–50; lower scores indicate fewer reflux-related symptoms and better quality of life. Mean difference is laparoscopic minus open; positive improvement values represent reduction from baseline. Between-group comparisons used Welch's independent-samples t test.

Table 4. Long-term clinical outcomes

Absolute risk difference is laparoscopic minus open and is presented with Newcombe 95% confidence intervals. Fisher exact tests were used for sparse outcomes; Pearson chi-square tests were used otherwise.

Both laparoscopic and open Nissen fundoplication were found to be effective in significantly improving GERD symptoms and GERD-specific quality of life at 24–36 months in this randomized controlled trial. The main differences were perioperative: the operative time for laparoscopic surgery was longer, but blood loss was significantly reduced, as was postoperative pain and the amount of analgesics required, while oral intake was earlier and hospital stay was shorter. There was a numerical decrease in postoperative complications following laparoscopy (5.0% vs 20.0%), but this was not statistically significant. The scores of the GERD-HRQL were significantly improved in both groups; the laparoscopic group had a significant advantage at 3 months, with similar scores from 6 months onward. Recurrent GERD at final follow-up was rare in both groups, and the overall success of treatment was similar (87.5% after laparoscopic surgery and 85.0% after open surgery).

The results of this study are similar to those of the long-term randomized comparison study by Broeders et al., which assessed 148 patients 10 years after laparoscopic or conventional Nissen fundoplication. Laparoscopic and open surgery relieved GERD symptoms in 92.4% and 90.7% of patients, respectively, and PPI use was also similar at 10 years (26.6% vs 22.4%). There was no significant difference between the approaches with regard to quality-of-life improvement [13]. That similarity in long-term reflux control in that trial is consistent with our experience that the primary benefit of laparoscopy is the recovery period following surgery.

Durability is still relevant as short- and intermediate-term success can decrease with longer follow-up. Laparoscopic Nissen fundoplication was performed on 249 patients by Kellokumpu et al.; the conversion rate was approximately 2.8%, the 30-day morbidity rate was 7.6%, and the median postoperative hospital stay was 2 days. Cumulative cure rates at 5 years and 10 years were 87.7% and 72.9%, respectively, although 98.4% of patients were deemed cured at 3 months [14]. The same low perioperative morbidity and high treatment success were seen in our laparoscopic group; however, the follow-up period was shorter (24–36 months), and later recurrence cannot be ruled out.

Some patients may need to take medication again or require further intervention, but long-term patient satisfaction can still be high. Kelly et al. published their results in patients followed for ≥10 years after laparoscopic Nissen fundoplication. Eighty-three percent were very satisfied, 84% had good or excellent heartburn control, and symptom scores were not significantly different from the 5-year assessment. However, 17% had undergone revision surgery and 21% had been prescribed antireflux drugs [15]. This is important because we found that about one-quarter of patients were still taking PPIs despite relatively low rates of clinically diagnosed recurrent GERD, so using PPIs does not necessarily mean treatment failure.

Patients who underwent primary laparoscopic fundoplication had a mean GERD-HRQL score of 5.71 and 71% were satisfied with the outcome at a median follow-up of 60 months, as shown by Gee et al. While 43% had used antireflux medication at any point since surgery, only 1.2% needed reoperation, and about half of those using medication had not had a diagnostic test to confirm recurrent GERD [16]. These results suggest that caution should be used when interpreting the use of PPIs after surgery and highlight the importance of using disease-specific quality-of-life measures in addition to medication use and symptom recurrence.

The early versus late patient-reported outcomes in our trial are also clinically reasonable. In a cohort of 316 patients who underwent either a Nissen or Toupet fundoplication, Gunter et al. did not observe any significant difference between the two procedures at 1, 3 or 5 years after surgery in terms of GERD-HRQL scores. Five-year satisfaction was high and similar (77.4% after Nissen and 70.0% after Toupet), and an early difference in dysphagia that was observed at 1 year was not seen at 3 or 5 years [17]. Their comparison was not of surgical access but of wrap configuration, but the study shows that differences in the early postoperative period may be reduced over time. The same trend was observed in our patients, with the lower GERD-HRQL score after laparoscopy at 3 months converging with the open group during follow-up.

The continuing improvement of both surgical groups is also in line with the evidence that fundoplication is effective for appropriately selected patients with GERD. Grant et al. reported that in the five-year REFLUX randomized trial, disease-specific quality of life was significantly improved with a surgical strategy, with a 5-year REFLUX score difference of 8.5 points. Forty-four percent of patients in the surgical group and 82% of those in the medical group were taking antireflux medication, while only 3% of the surgical group required surgery for a complication and 4% required another reflux-related operation [18]. Our study did not have a medical-treatment arm, but the significant improvement in GERD-HRQL scores in both surgical groups is consistent with the sustained symptomatic improvement seen in the surgical arm of that trial.

Even with good reflux control, post-fundoplication symptoms are important. Makal and Türkçapar reported a mean follow-up period of 60 months following laparoscopic Nissen fundoplication and found that 17.2% of patients had heartburn and 17.7% had regurgitation. Twenty-five percent of the subjects could not belch, 38.1% had flatulence, and overall satisfaction was 82.8% [19]. Persistent dysphagia was rare in our study (2.5% in each group), while persistent gas-bloat symptoms were seen in 15.0% and 17.5% of laparoscopic and open patients, respectively. This further emphasizes the need to differentiate postoperative functional symptoms from true reflux.

Routine clinical experience in hospitals also confirms the durability of laparoscopic fundoplication. In a regional hospital setting, Prassas et al. reported a median follow-up of 8.8 years, with 60.8% of respondents having complete control of heartburn, 6% undergoing revisional surgery, 73.6% reporting a lasting improvement in overall quality of life, and 85% stating that they would undergo the surgery again [20]. Our treatment success rate of 87.5% after laparoscopic surgery is therefore broadly comparable, although our follow-up period was much shorter than that in the Prassas et al. study.

The present study has a number of strengths: it was randomized, two different operative approaches were directly compared using similar surgical principles, it used a disease-specific quality-of-life instrument for serial assessment, and it evaluated both perioperative recovery and longer-term outcomes. The results indicate that laparoscopic surgery offers significant short-term benefits without compromising symptom control or quality of life.

Limitations

This study was conducted at a single center with a relatively small sample size of 80 patients, which may have limited the ability to detect differences in uncommon outcomes such as recurrence, complications, and reoperation. The follow-up period of 24–36 months was adequate for intermediate-term assessment but was shorter than that of several long-term comparator studies, and routine postoperative objective testing was not performed in all patients.,

Both laparoscopic and open Nissen fundoplication provided effective symptom control and substantial improvement in GERD-related quality of life. Laparoscopic surgery offered clear perioperative advantages, including less blood loss, reduced postoperative pain, earlier oral intake, and shorter hospital stay, while long-term reflux control, GERD-HRQL, medication use, dysphagia, gas-bloat symptoms, and overall treatment success were comparable between the two approaches.

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