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

Journal Article (Clinical Trial;Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Richards, WO; Torquati, A; Holzman, MD; Khaitan, L; Byrne, D; Lutfi, R; Sharp, KW

Published Date

  • September 2004

Published In

Volume / Issue

  • 240 / 3

Start / End Page

  • 405 - 412

PubMed ID

  • 15319712

Pubmed Central ID

  • PMC1356431

International Standard Serial Number (ISSN)

  • 0003-4932

Digital Object Identifier (DOI)

  • 10.1097/01.sla.0000136940.32255.51


  • eng

Conference Location

  • United States