Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: a prospective randomized double-blind clinical trial

Abstract

Objective: We sought to determine the impact of the addition of Dor fundoplication on the incidence of postoperative gastroesophageal reflux (GER) after Heller myotomy.

Summary background data: Based only on case series, many surgeons believe that an antireflux procedure should be added to the Heller myotomy. However, no prospective randomized data support this approach.

Patients and methods: In this prospective, randomized, double-blind, institutional review board-approved clinical trial, patients with achalasia were assigned to undergo Heller myotomy or Heller myotomy plus Dor fundoplication. Patients were studied via 24-hour pH study and manometry at 6 months postoperatively. Pathologic GER was defined as distal esophageal time acid exposure time greater than 4.2% per 24-hour period. The outcome variables were analyzed on an intention-to-treat basis.

Results: Forty-three patients were enrolled. There were no differences in the baseline characteristics between study groups. Pathologic GER occurred in 10 of 21 patients (47.6%) after Heller and in 2 of 22 patients (9.1%) after Heller plus Dor (P = 0.005). Heller plus Dor was associated with a significant reduction in the risk of GER (relative risk 0.11; 95% confidence interval 0.02-0.59; P = 0.01). Median distal esophageal acid exposure time was lower in the Heller plus Dor (0.4%; range, 0-16.7) compared with the Heller group (4.9%; range, 0.1-43.6; P = 0.001). No significant difference in surgical outcome between the 2 techniques with respect to postoperative lower-esophageal sphincter pressure or postoperative dysphagia score was observed.

Conclusions: Heller Myotomy plus Dor Fundoplication was superior to Heller myotomy alone in regard to the incidence of postoperative GER.

FIGURE 1. Edges of esophageal and gastric muscle layers displayed at completion of myotomy. The top part of the cardia is sutured to the left crural pillar of the diaphragm and to the left side of the myotomy at the most superior aspect.

FIGURE 2. Creation of the Dor fundoplication. The uppermost suture is used to anchor the fundic flap to right side of the myotomy incorporating the right crural pillar.

FIGURE 3. Completion of the Dor fundoplication. The gastric fundus is joined with the inferior aspect of the right side of the myotomy.

FIGURE 4. Postoperative LES pressure in the 2 groups. Data are shown as median (horizontal line), interquartile range (box), and 5th to 95th percentile (vertical line). In both groups, the pressure dropped significantly from preoperative values.

FIGURE 5. Incidence of pathologic GER in the 2 groups using the intention to treat analysis. *P = 0.005 versus Heller plus Dor.

FIGURE 6. Distal esophageal acid exposure in the 2 groups. Data are shown as median (horizontal line), interquartile range (box), and 5th to 95th percentile (vertical line). *P = 0.001 versus Heller plus Dor.

FIGURE 7. DeMeester scores in the 2 groups. Data are shown as median (horizontal line), interquartile range (box), and 5th to 95th percentile (vertical line). *P = 0.01 versus Heller plus Dor.

FIGURE 8. Postoperative dysphagia scores in the 2 groups. Data are shown as median (horizontal line), interquartile range (box), and 5th to 95th percentile (vertical line).