Clinical Outcomes and Quality of Life after Laparoscopic Nissen Fundoplication for Refractory Gastroesophageal Reflux Disease: A Prospective Cohort Study from Vietnam

Abstract

Background/Aims

Gastroesophageal reflux disease (GERD) significantly impairs quality of life. Although proton pump inhibitors are first-line therapy, a subset of patients remains refractory to medical treatment. Laparoscopic Nissen fundoplication (LNF) is considered the gold-standard surgical option; however, high-quality prospective outcome data from Southeast Asia, particularly Vietnam, remain limited. This study aimed to evaluate clinical outcomes and symptom control following LNF in patients with refractory GERD.

Methods

This prospective cohort study included 61 consecutive patients with refractory GERD who underwent LNF at Can Tho General Hospital between March 2022 and September 2025. Gastroesophageal reflux disease questionnaire (GERD-Q) scores and symptom control were assessed at 1 month, 6 months, 12 months, and at the end of follow-up.

Results

The mean age was 38.9±14.3 years, and 54.1% of patients were male. All procedures were completed laparoscopically, with a mean operative time of 102.3±17.4 minutes. Postoperative recovery was rapid, with early resumption of oral intake and ambulation. Postoperative complications occurred in 19.7% of patients and were limited to Clavien-Dindo grades I-II, with no mortality. GERD-Q scores decreased significantly from 14.26±1.69 preoperatively to 7.00±0.99 at 1 month and continued to decline during follow-up, reaching 5.41±1.18 at the end of the study (p<0.001). Good symptom control was maintained in 83.6–90.2% of patients across follow-up time points.

Conclusions

LNF is a safe and effective treatment for refractory GERD, providing rapid recovery and durable symptom control in appropriately selected patients.

INTRODUCTION

Gastroesophageal reflux disease (GERD) is a highly prevalent chronic gastrointestinal disorder caused by the retrograde flow of gastric contents into the esophagus, leading to troublesome symptoms and impaired quality of life. Contemporary epidemiologic data suggest that GERD affects approximately 8–30% of adults worldwide, with a continuously increasing burden across Western and Asian populations.^1,2 In Asia, the prevalence of GERD has risen markedly in recent decades in parallel with dietary westernization, population aging, obesity, and improved diagnostic awareness.^3,4

Clinically, GERD is characterized by heartburn and regurgitation but may also present with extraesophageal manifestations, including chronic cough, hoarseness, and respiratory symptoms.⁵ Endoscopic phenotypes range from erosive esophagitis to non-erosive reflux disease (NERD) and minimal-change esophagitis, which are increasingly recognized in modern clinical practice.^6,7 Persistent reflux can lead to complications such as strictures and Barrett’s esophagus, highlighting the need for durable symptom control and effective long-term management strategies.^5,6

Proton pump inhibitors (PPIs) are the cornerstone of initial therapy, but up to 30–40% of patients experience persistent or recurrent symptoms despite optimized medical treatment, constituting refractory GERD.^8,9 In addition, growing concerns regarding potential adverse events associated with prolonged PPI use have fueled interest in definitive antireflux therapies.¹⁰ Laparoscopic Nissen fundoplication (LNF) is widely considered the gold standard surgical option for appropriately selected patients with refractory GERD, particularly in the presence of objective reflux evidence or concomitant hiatal hernia, or both.^11,12 Updated diagnostic frameworks, including the Lyon Consensus 2.0, have standardized GERD phenotyping and improved patient selection for invasive therapies.⁸ Contemporary comparative studies have shown that antireflux surgery achieves high rates of symptom resolution and patient satisfaction, with durable success exceeding 80–90% when performed in experienced centers.^10-17 Long-term follow-up studies confirmed sustained improvements in the disease-specific quality of life after LNF.^9,13,18

Advances in surgical technique, including standardized floppy fundoplication and optimized hiatal repair, have contributed to improved functional outcomes and reduced postoperative dysphagia.^19,20 Despite the robust international evidence, prospective outcome data on laparoscopic antireflux surgery from Southeast Asia, including Vietnam, are limited, with available regional reports often being retrospective or involving small cohorts.

In particular, patients undergoing surgical treatment for GERD in Vietnam tend to be relatively young, likely reflecting demographic characteristics, healthcare-seeking behavior, and referral patterns at tertiary centers. Therefore, the findings of the present study primarily reflect the outcomes in this younger Vietnamese patient subgroup rather than the broader Southeast Asian population.

Accordingly, this prospective cohort study evaluated the early and mid-term clinical outcomes, postoperative recovery, symptom control, and patient satisfaction following laparoscopic Nissen fundoplication in patients with refractory GERD at a specialized digestive surgery center in Vietnam.

SUBJECTS AND METHODS

1. Study design and patients

This prospective observational cohort study was conducted at the Department of General Surgery, Can Tho General Hospital, Vietnam, between March 2022 and September 2025, with follow-up completed in November 2025. Consecutive adult patients with refractory GERD undergoing laparoscopic Nissen fundoplication were enrolled prospectively. The institutional ethics committee approved this study (approval No. 04/2022/CN-HDDD, February 17, 2022), and written informed consent was obtained from all participants prior to enrollment.

The inclusion criteria were consecutive adult patients (≥18 years) with refractory GERD who had typical symptoms (heartburn and regurgitation) persisting despite optimized proton pump inhibitor therapy for at least eight weeks, a Gastroesophageal reflux disease questionnaire (GERD-Q) score ≥8, and objective evidence of reflux, including Los Angeles grade A–D esophagitis, pathological acid exposure on 24-hour esophageal pH monitoring when available, or hiatal hernia with typical symptoms and supportive endoscopic features, who underwent primary LNF.

The exclusion criteria were prior antireflux surgery; esophageal malignancy, achalasia, or major esophageal motility disorders; severe cardiopulmonary comorbidities precluding surgery; pregnancy; and incomplete baseline or follow-up data.

2. Preoperative assessment

All patients underwent standardized evaluation, including GERD-Q symptom assessment, disease-specific quality-of-life assessment using the Gastroesophageal Reflux Disease– Health-Related Quality of Life (GERD-HRQL) questionnaire, upper gastrointestinal endoscopy (Los Angeles grade, Hill flap valve, and hiatal hernia), routine laboratory tests and American Society of Anesthesiologists (ASA) physical status classification, and additional investigations (barium swallow or 24-hour pH monitoring) when indicated.

3. Surgical technique

All procedures were performed laparoscopically by experienced digestive surgeons using a standardized short floppy Nissen fundoplication technique. After pneumoperitoneum and trocar placement were established (Fig. 1), the distal esophagus was circumferentially mobilized to obtain at least 3–4 cm of intra-abdominal length (Fig. 2A, 2B). The gastric fundus was fully mobilized, and a 360° posterior fundoplication was constructed using three to four interrupted non-absorbable sutures, with a wrap length of approximately 2.5–3 cm to avoid a functional obstruction (Fig. 2C, 2D). The final inspection confirmed hemostasis and integrity of the esophagogastric junction before the procedure was completed.

Fig. 1.

Patient position (A) and trocar placement (B).

Fig. 2.

Key steps of laparoscopic Nissen fundoplication. (A) Percutaneous suspension of the left hepatic lobe for exposure of the esophagogastric junction; (B) Dissection and mobilization of the distal esophagus and proximal stomach; (C) Construction of a short, floppy 360° fundic wrap; and (D) Final configuration of the fundoplication.

4. Postoperative management

Postoperative care followed a standardized enhanced recovery protocol. The oral liquid intake was initiated once the bowel sounds returned and gradually advanced to soft and regular diets. Early ambulation was encouraged in all patients.

5. Outcome measures

The primary outcome measures were the changes in GERD-Q scores over the follow-up period and the rate of effective symptom control. Effective symptom control was defined as a GERD-Q score <8 at each follow-up assessment.

The secondary outcome measures included postoperative complications, graded according to the Clavien–Dindo classification, as well as postoperative recovery parameters, including time to oral intake, time to ambulation, and time to first flatus. Additional secondary outcomes were the length of postoperative hospital stay and total hospital stay, disease-specific quality of life, and patient satisfaction assessed using the GERD-HRQL questionnaire, and recurrence or the need for reintervention.

Recurrence was defined as the return of typical reflux symptoms requiring an escalation of medical therapy and endoscopic evidence of recurrent reflux or recurrent herniation when a further evaluation was performed.

6. Follow-up

The patients were followed at one month, six months, 12 months, and at the end of follow-up. The follow-up assessments included clinical examination and completion of the GERD-Q questionnaire. Upper gastrointestinal endoscopy was performed when clinically indicated.

7. Statistical analysis

Statistical analysis was performed using SPSS version 22.0 (IBM Corp., Armonk, NY, USA). The continuous variables are reported as the mean±standard deviation or median, as appropriate. The categorical variables were expressed as numbers and percentages. The normality of the distribution was assessed using the Shapiro–Wilk test. Pre- and postoperative GERD-Q scores were compared using paired t-tests or Wilcoxon signed-rank tests, where appropriate. A p-value <0.05 was considered significant.

RESULTS

Sixty-one patients with refractory GERD underwent laparoscopic Nissen fundoplication between March 2022 and September 2025. The mean age was 38.9±14.3 years (range, 20–76), and 54.1% were male. The patients had a relatively long disease duration (mean 4.8±2.9 years) and prolonged medical treatment before surgery (35.5±18.5 months). The common GERD risk factors included high-fat, caffeine, or chocolate intake (50.8%), alcohol consumption (37.7%), and smoking (29.5%). Typical symptoms, such as heartburn and regurgitation, were present in more than 90% of patients (Table 1).

Table 1.

Baseline Demographic and Clinical Characteristics

Characteristics	Results
Age (years)	38.9±14.3 (20–76)
Male sex	33 (54.1)
BMI (kg/m²)	20.66±3.50
Underweight (<18.5)	26 (42.6)
Normal (18.5–22.9)	23 (37.7)
Overweight (23–24.9)	7 (11.5)
Obese (≥25)	5 (8.2)
Comorbidities present	10 (16.4)
Previous abdominal surgery	9 (14.8)
Disease duration (years)	4.8±2.9 (1.5–20)
Medical treatment duration (months)	35.5±18.5 (12–120)

Values are presented as mean ± standard deviation (range) or number (%).

BMI, body mass index.

BMI categories were defined using WHO Asia-Pacific criteria.

The endoscopic findings showed predominantly mild esophageal involvement, with Los Angeles grade A esophagitis in 62.3% and normal endoscopy (NERD) in 37.7% of patients. Hiatal hernia was identified in 36.1% (Table 2). All procedures were completed laparoscopically, with a mean operative time of 102.3±17.4 minutes (Table 3). Early postoperative recovery was favorable, with oral intake resumed after 14.8±4.6 hours and ambulation after 15.8±3.7 hours (Table 4).

Table 2.

GERD Risk Factors and Clinical Manifestations

Variables	Results
Smoking	18 (29.5)
Alcohol consumption	23 (37.7)
High-fat/caffeine/chocolate intake	31 (50.8)
Overweight/obesity	12 (19.7)
Heartburn	55 (90.2)
Regurgitation	55 (90.2)
Epigastric pain	49 (80.3)
Nausea/vomiting	46 (75.4)
Halitosis	46 (75.4)
Pharyngitis	43 (70.5)
Dysphagia	24 (39.3)
Respiratory symptoms	22 (36.1)

Values are presented as number (%).

GERD, gastroesophageal reflux disease.

Table 3.

Endoscopic Findings and Operative Details

Findings	Results
Los Angeles grade A	38 (62.3)
Normal endoscopy (NERD)	23 (37.7)
Hill grade I	32 (52.5)
Hill grade II	29 (47.5)
Hiatal hernia	22 (36.1)
5-trocar technique	60 (98.4)
Intraoperative bleeding	4 (6.6)
Laparoscopic completion	61 (100)

Values are presented as number (%).

NERD, non-erosive reflux disease.

Table 4.

Early Postoperative Recovery and Complications

Parameter	Results
Operative time (min)	102.3±17.4 (75–190)
Oral intake recovery (h)	14.8±4.6 (6–24)
Ambulation (h)	15.8±3.7 (10–24)
Flatus passage (h)	17.3±5.1 (8–20)
Total hospital stay (days)	10.3±3.2 (7–17)
Post-op stay (days),	6.1±3.5 (4–15)
Total complication	12 (19.7)
Clavien–Dindo I	10 (16.4)
Clavien–Dindo II	2 (3.3)
Clavien ≥III	0
Mortality	0

Values are presented as mean ± standard deviation (range) or number (%).

No major intraoperative complications occurred, and intraoperative bleeding was minimal without the need for conversion or transfusion. Postoperative complications were observed in 12 patients (19.7%), all limited to Clavien–Dindo grade I–II events. The majority consisted of transient functional adverse symptoms, including dysphagia (9.8%), gas-bloat syndrome (6.6%), and transient delayed gastric emptying (1.6%), all managed conservatively (Table 5). Only one patient developed a minor trocar-site infection (1.6%), which required oral antibiotics. No reoperations or mortality were observed.

Table 5.

Postoperative Complications According to Clavien–Dindo Classification

Clavien–Dindo grade	Specific complication	Number (%)
Grade I	Transient dysphagia	6 (9.8)
	Gas-bloat syndrome	4 (6.6)
	Transient delayed gastric emptying	1 (1.6)
Grade II	Umbilical trocar-site infection	1 (1.6)
Grade ≥ III	None	0
Total		12 (19.7)

All complications were managed conservatively. No reoperations or mortality occurred.

The mean postoperative length of stay was 6.1±3.5 days, and the total hospital stay was 10.3±3.2 days (Table 4). The GERD-Q scores decreased markedly from 14.26±1.69 preoperatively to 7.00±0.99 at one month and continued to decline during the follow-up, reaching 5.41±1.18 at the end of the study. Good symptom control remained high across follow-up (Table 6), with 90.2% at one month and 83.6% at the final follow-up, showing sustained postoperative symptom improvement (Fig. 3).

Table 6.

GERD-Q Scores and Symptom Control During Follow-up

Time point	Number	GERD-Q	Good symptom control
Preoperative	61	14.26±1.69 (11–17)	–
1 month	61	7.00±0.99 (6–9)	55 (90.2)
6 months	54	6.62±0.89 (5–11)	48 (88.9)
12 months	54	5.84±1.21 (4–12)	47 (87.0)
End of follow-up	61	5.41±1.18 (4–12)	51 (83.6)

Values are presented as mean ± standard deviation (range) or number (%).

GERD-Q, gastroesophageal reflux disease questionnaire.

At the time of analysis, 54 patients had reached the 6- and 12-month visits, whereas seven patients had not yet reached these scheduled visits. All 61 patients were evaluated at the final follow-up.

Fig. 3.

The inverse trend between GERD-Q scores and symptom control demonstrates that reflux symptom severity continuously decreased while high rates of satisfactory clinical outcomes were maintained throughout postoperative follow-up. GERD-Q, gastroesophageal reflux disease questionnaire.

DISCUSSION

This prospective cohort study showed that LNF is an effective and safe treatment modality for patients with refractory GERD, providing rapid symptom relief, sustained reduction in GERD-Q scores, low perioperative morbidity, and high patient satisfaction during mid-term follow-up.

A significant and progressive decline in GERD-Q scores was observed in this cohort, decreasing from a baseline of 14.26±1.69 to 7.00±0.99 at one month postoperatively and stabilizing at 5.41±1.18 at the final follow-up (p<0.001). These findings suggest that maximal symptomatic improvement is achieved early after surgery and is sustained over time. This clinical trajectory is consistent with contemporary Asian and international studies reporting durable symptom control and sustained disease-specific quality-of-life improvement after LNF.^11,13 The proportion of patients achieving good symptom control in this series (83.6–90.2%) is comparable to global success rates of approximately 80–90% reported in large comparative studies and meta-analyses,^8-10,13,17 supporting the effectiveness of LNF within the Southeast Asian population. Improvement in typical and extraesophageal symptoms further reflects the restoration of the antireflux barrier, as emphasized in modern diagnostic and therapeutic guidelines for refractory GERD.^8,9

All procedures were completed laparoscopically without conversion to open surgery, supporting the feasibility and safety of LNF in routine Vietnamese clinical practice. The mean operative time (102.3±17.4 minutes) was slightly longer than that reported in some contemporary series,¹⁴ likely because of the relatively high prevalence of concomitant hiatal hernia (36.1%) requiring crural repair, as well as the early phase of standardization of the technique at the authors’ center. Postoperative recovery was favorable, with the early resumption of oral intake, early ambulation, and a short postoperative hospital stay, comparable to international benchmarks and enhanced recovery protocols. ^9,11 These outcomes highlight the advantages of minimally invasive antireflux surgery in optimizing recovery and improving the efficiency of healthcare.

The overall perioperative complication rate was 19.7%, limited to Clavien–Dindo grade I–II events. Postoperative dysphagia and gas-bloating were the most frequent adverse effects, but were transient and managed conservatively. The present dysphagia rate of approximately 10% compares favorably with previous Western series reporting rates between 10% and 25%.^9,11,15

Preoperative dysphagia was relatively common in this cohort and can be attributed to chronic reflux-associated esophagitis, hiatal hernia, or functional esophageal impairment related to longstanding GERD. In contrast, postoperative dysphagia was mild and self-limited, likely reflecting transient postoperative edema or functional adaptation to the fundoplication rather than structural obstruction. No cases of esophageal stricture, wrap migration, or need for endoscopic intervention or reoperation were observed. These findings suggest that preoperative and postoperative dysphagia in the present cohort were not directly correlated and likely reflected different underlying pathophysiological mechanisms.

This favorable profile may be attributed to careful wrap calibration and standardized construction of a short, floppy fundoplication, which are recognized technical refinements aimed at minimizing functional obstruction.²¹ Transient delayed gastric emptying following LNF has been described but is generally self-limited and clinically manageable.¹⁴ Importantly, no severe complications such as wrap migration, recurrent hiatal hernia, or reoperation were observed in the cohort, suggesting robust technical performance and appropriate patient selection.

High patient satisfaction was observed, with 83.6% of patients achieving good symptom control at the final follow-up. These findings are consistent with long-term outcome studies reporting durable symptom relief and satisfaction rates approaching 85–90% after LNF.¹³ The sustained inverse relationship between GERD-Q scores and symptom burden throughout follow-up further supports the durability of symptom relief and highlights the utility of GERD-Q as a practical tool for postoperative symptom monitoring.

Heterogeneous GERD phenotypes, particularly non-erosive reflux disease and minimal-change esophagitis, are increasingly recognized in Asian populations and are frequently associated with refractory symptoms despite proton pump inhibitor therapy.^4,5,11,16 Contemporary consensus recommendations advocate standardized diagnostic evaluation and tailored management for refractory GERD.^7,9 Diagnostic standardization using the Montreal definition, GERD-Q symptom assessment, and Hill classification of the gastroesophageal flap valve further strengthens patient selection and enhances the consistency of outcome assessment across studies.^22,23

The laparoscopic antireflux technique used in this cohort is based on the classical principles described by Nissen and subsequently refined and standardized in contemporary laparoscopic series.²⁰ The long-term durability of LNF is well established, with five- and seven-year outcome studies showing sustained symptom relief and high patient satisfaction. The failure patterns are primarily related to wrap disruption, slippage, and recurrent hiatal hernia,²⁴ underscoring the importance of standardized technical steps, including meticulous crural repair and short floppy wrap construction as recommended in contemporary technical guidelines.²⁴ The long-term durability may also be influenced by hiatal hernia repair strategies, particularly in patients with concomitant herniation.¹⁵

International consensus statements emphasize standardized diagnostic evaluation and consideration of antireflux interventions for appropriately selected patients with refractory GERD.^8,9 Nevertheless, antireflux surgery remains underutilized in Vietnam, which may be partly due to the limited access to specialized minimally invasive services and objective diagnostic testing. The prospective data from a high-volume regional center showed outcomes comparable to international benchmarks and may support the wider consideration of LNF in Vietnam as the burden of GERD continues to increase across Asia.^1-3

This prospective single-center study had several limitations that should be acknowledged. First, the relatively small sample size and single-center design may limit the generalizability of the findings to other clinical settings with different patient populations and levels of surgical expertise. Second, although favorable mid-term outcomes were observed, the follow-up duration may not be sufficient to achieve long-term durability, prevent late recurrence, or delay functional complications. In addition, objective esophageal functional assessments, including 24-hour pH monitoring and high-resolution manometry, were not routinely available during the study period because of equipment limitations. Consequently, patient selection and postoperative outcome assessment were based primarily on the clinical presentation, endoscopic findings, and symptom- based evaluation using the GERD-Q questionnaire, which may limit the correlation with the physiologic reflux parameters. Future multicenter studies with larger cohorts, comprehensive esophageal functional testing, and longer follow-up will be needed to validate and expand these findings.

LNF is a safe and effective treatment for refractory gastroesophageal reflux disease, providing rapid and durable symptom relief with low perioperative morbidity and high patient satisfaction in a Southeast Asian population. The outcomes achieved at this center are comparable to international benchmarks and support wider consideration of this procedure in appropriately selected patients in Vietnam.