A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication (LNF) versus Proton Pump Inhibitors for Treatment of Patients with Chronic Gastro-Esophageal Reflux Disease (GERD)
Mehran Anvari1, Christopher J. Allen2, ELVIS Research Group and3; 1Surgery, McMaster University, Hamilton, ON, Canada; 2Medicine, McMaster University, Hamilton, ON, Canada; 3McMaster University, Hamilton, ON, Canada
Background: In patients with GERD who were stable and symptomatically controlled on long-term medical therapy we performed an RCT to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF). Methods: The entry criteria were; (1) Males or females 18-70 years with chronic symptoms of GERD requiring long-term therapy, (2) Prior long-term treatment with PPI with minimum duration of one year with expected future duration of at least two more years (3) Symptoms controlled prior to study, defined as GERD Symptom score < 18 (without cough) and score of 70 or more on 1-100 Global Rating Scale (GRS) at screening (on medication), (4) Percent acid reflux in 24 hr > 4% at baseline (off medication). 201 patients were eligible for randomization, 104 gave informed consent (mean age 42.4±1.07 male 56 female 48). Patients randomized to medical therapy received optimized treatment with PPI using a standardized management protocol based on best evidence and published guidelines. Surgical patients underwent LNF by four surgeons using previously published technique. Patients underwent symptom evaluation every 3 months using a published and validated instrument and 24 hour pH testing after 1 year. Results: 98 patients were available for follow up, and both medical and surgical patients improved significantly with regard to both 24 hour pH (medical p=0.0204, surgical p<0.0001), GERD symptoms (both groups p<0.0001). The overall symptom control score (GRS) at one year was unchanged compared to baseline in the medical patients (p=0.084) but improved in the surgical patients (p<0.0001). When the changes in the medical and the surgical patients were compared using repeated measures ANOVA there was no significant difference between the groups in improvement in pH (p = 0.2723) but the surgical patients had a significantly greater improvement in symptom scores (p<0.0001). Conclusions: Patients controlled on long term PPI therapy for chronic GERD are excellent surgical candidates and should experience improved symptom control after surgery.
| | Medical | Surgical | Improvement: Surg vs Med | ||
| | Initial (off PPI) | 1 Year (on PPI) | Initial (off PPI) | 1 Year (off PPI) | p |
| % pH < 4 | 9.30±0.78 | 5.44±1.57 | 10.26±1.63 | 1.50±0.57 | 0.2723 |
| GERD Score | 29.48±1.97 | 12.82±1.60 | 30.82±1.52 | 8.46±1.23 | <0.0001 |
| GRS | 82.5±1.55 (on PPI) | 73.3±3.43 | 81.5±1.84 | 90.2±2.04 | <0.0001 |
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