Arthur Rawlings, MD, Nathaniel J Soper, MD, Brant Oelschlager, MD, Lee Swanstrom, MD, Brent D Matthews, MD, Carlos Pellegrini, MD, Richard A Pierce, MD PhD, Aurora Pryor, MD, Valeria Martin, MD, Margaret M Frisella, RN, Maria Cassera, RN, L. Michae. Departments of Surgery, Washington University School of Medicine-St. Louis, Northwestern University, Chicago, IL, University of Washington, Seattle, WA, The Oregon Clinic, Portland, OR, Duke University, Durham, NC
Introduction: Laparoscopic Heller myotomy with partial fundoplication (FP) is the preferred treatment for esophageal achalasia. However, the type of fundoplication that should be performed is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy.
Methods: A multicenter, prospective, randomized-controlled trial was initiated to compare outcomes of Dor vs Toupet fundoplication after laparoscopic Heller myotomy for achalasia. Outcome measures were symptomatic GERD scores (0-4, five point Likert scale questionnaire) at 2-6 weeks, 6 months, and 12 months postoperatively, and 24 hour pH testing at 6 months. Data are mean ± SD. Statistical analysis was by Mann Whitney U test and Wilcoxon signed rank test.
Results: Eighty-five patients were enrolled at 5 sites and were randomized to 49 Dor and 36 Toupet FP’s. The Dor and Toupet groups were similar in age (45.6 vs 49.7 yrs) and gender (61.2% vs 61.1% male). Six month pH studies were obtained in 22 of 49 (40.8%) of the Dor patients and 18 of 36 (50%) of Toupet patients. The DeMeester score was >14.7 in 9 of 22 patients (40.9%) in the Dor group and in 3 of 18 patients (16.7%) in the Toupet group (p=0.037), although the total DeMeester scores (table) and % pH time <4 were NS between groups. Dysphagia and regurgitation symptom scores in the patients who underwent pH testing improved significantly in both groups compared to pre-op at all follow-up time points (see Table Pre-op vs 6 months). No significant differences between the Dor vs Toupet groups were noted for any esophageal symptoms pre-op or at any of the follow-up periods.
|Parameter||Dor Pre-op||Dor 6 mos||Toupet Pre-op||Toupet 6 mos|
|Solid dysphagia||3.0 ± 1.0||1.3 ± 0.8**||3.1 ± 1.1||1.0 ± 1.0**|
|Heartburn||1.5 ±1.3||0.7 ± 0.8||1.0 ± 1.2||0.3 ± 1.0*|
|Regurgitation||2.8 ± 1.2||0.7 ± 1.0**||3.3 ± 0.7||0.1 ± 0.3**|
|DeMeester pH score||NA||7.2 (0.2-131)||NA||2.2 (0.2-107)|
*p< 0.05, ** p≤0.01 pre vs 6 months postop.
DeMeester pH score = median score and range
Conclusion: Laparoscopic Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. However, based on a 47% follow-up at 6 months, the Dor fundoplication was associated with a significantly higher percentage of patients with abnormal reflux than the Toupet FP despite no symptomatic differences.
Program Number: S035