title: Relationship between subjective and objective outcome measures after Heller myotomy and Dor fundoplication for achalasia.
abstract: BACKGROUND
  The purpose of this study is to assess how subjective evaluation (heartburn, dysphagia, quality of life, and satisfaction) correlates with objective data after Heller myotomy and Dor fundoplication for achalasia.
  
  
  METHODS
  A total of 53 consecutive patients with achalasia undergoing laparoscopic Heller myotomy and Dor fundoplication were studied prospectively. Subjective evaluation was done preop and postop using the Gastroesophageal Reflux Disease Health-Related Quality of Life instrument (GERD-HRQL; 0 = best, 45 = worse), 4-point dysphagia and heartburn scales (0 = best, 3 = worst), patient satisfaction scale (0 = very satisfied, 5 = incapacitated), and the SF-12 general health-related quality-of-life score. At 3 months postop, patients were asked to undergo objective evaluation with 24-h pH testing, manometry, and endoscopy. Data are expressed as median (interquartile range) and analyzed by Wilcoxon signed rank test or Mann-Whitney U test.
  
  
  RESULTS
  Forty-nine patients were more than 3 months postsurgery. Comparing preop to postop, improvements were found in dysphagia [3 (2-3) to 0 (0-1)], heartburn [1 (0-2) to 0 (0-1)], GERD-HRQL [13.5 (6.3-22.5) to 2 (0-5)], satisfaction [3 (3-4) to 1 (0-1)], and SF-12 mental component summary [46 (37-56) to 58 (50-59)] and physical component summary [46 (36-53) to 55 (48-56)] scores (p < 0.0001 for all). Thirty-eight patients (78%) agreed to undergo objective testing, and complete data were available for 32 (65%). Four of 32 patients (12.5%) had evidence of reflux based on 24-h pH testing. Of nine patients with GERD-HRQL >5, only two had positive pH test (22%). Of 23 patients with GERD-HRQL <5, two had positive pH test (7%). Of four tested patients with moderate to severe heartburn, two had an abnormal pH test. There was no significant relationship between GERD-HRQL score and pH test results. Lower esophageal sphincter pressure (LESP) decreased from 24 (16-35) to 13 mmHg (11-17) (p < 0.001). There was no relationship between dysphagia score and postop absolute LESP or a decrease in LESP after operation.
  
  
  CONCLUSIONS
  Laparoscopic Heller myotomy and Dor fundoplication is an effective treatment for achalasia. Subjective evaluation can document patient satisfaction and health-related quality of life but does not accurately reflect postop reflux. Twenty-four-hour pH study is required to accurately assess reflux disease.
authors.affiliation: Steinberg-Bernstein Centre for Minimally Invasive Surgery, 1650 Cedar Avenue, Room L9.309, Montreal, Quebec, H3G 1A4, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Gholoum
authors.forename: L S
authors.initials: LS
authors.lastname: Feldman
authors.forename: C G
authors.initials: CG
authors.lastname: Andrew
authors.forename: S
authors.initials: S
authors.lastname: Bergman
authors.forename: S
authors.initials: S
authors.lastname: Demyttenaere
authors.forename: S
authors.initials: S
authors.lastname: Mayrand
authors.forename: D D
authors.initials: DD
authors.lastname: Stanbridge
authors.forename: G M
authors.initials: GM
authors.lastname: Fried
mesh_terms: D000328:Adult; D004931:Esophageal Achalasia / Q000601:surgery*; D005260:Female; D018662:Fundoplication / Q000009:adverse effects; D005764:Gastroesophageal Reflux / Q000209:etiology; D006304:Health Status; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome