Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: a prospective randomized double-blind clinical trial.
OBJECTIVE
We sought to determine the impact of the addition of Dor fundoplication on the incidence of postoperative gastroesophageal reflux (GER) after Heller myotomy.


BACKGROUND
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.


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.
Department of Surgery, Vanderbilt University, Medical School, Nashville, Tennessee 37232, USA. bill.richards@vanderbilt.edu
William O
WO
Richards
Alfonso
A
Torquati
Michael D
MD
Holzman
Leena
L
Khaitan
Daniel
D
Byrne
Rami
R
Lutfi
Kenneth W
KW
Sharp
D000328:Adult; D000368:Aged; D013505:Digestive System Surgical Procedures / Q000009:adverse effects; D004311:Double-Blind Method; D004931:Esophageal Achalasia / Q000503:physiopathology / Q000601:surgery*; D004943:Esophagogastric Junction / Q000503:physiopathology; D004947:Esophagus / Q000378:metabolism / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D018662:Fundoplication / Q000379:methods; D005764:Gastroesophageal Reflux / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D006863:Hydrogen-Ion Concentration; D010535:Laparoscopy; D008297:Male; D008365:Manometry; D008875:Middle Aged; D011183:Postoperative Complications