Objectives: There is considerable discussion regarding “success” rates for laparoscopic antireflux surgery (LARS). We hypothesized that, in part, this was a reflection of the outcome variables used. We, therefore, defined 8 specific variables (within 3 categories) and assessed outcomes for each in a large cohort of patients.
Methods: Four hundred patients (208 women; median age 52 years old) who underwent LARS at the University of Washington from 1993 to 2008 were given a comprehensive questionnaire to assess various aspects of their outcomes from LARS. In addition, we analyzed all functional studies and all endoscopies performed in these patients in our institution, whether the patients had symptoms or not, and compared the findings to all available preoperative values.
Results: The median follow-up was 92 (6–175) months.
Effect on presenting symptoms: Heartburn (N = 376) improved in 326 (87%), regurgitation (N = 365) improved in 331 (91%), and chest pain (N = 265) improved in 207 (78%) patients, measured by patient's perception.
Durability: The percentage of patients with successful control of gastroesophageal reflux disease (GERD) symptoms: 88% at 1 year, 83% at 2 years, 77% at 5 years, and 74% after 10 years.
Development of new symptoms (side-effects): The following side-effects developed (ie, were new) or worsened (ie, were present before surgery): dysphagia in 72 (18%), bloating in 96 (24%), and diarrhea in 61 (15%) patients. The severities (0–10 scale) of these symptoms were: dysphagia 5.1 ± 2.6, bloating 6.5 ± 2.2, diarrhea 6.5 ± 2.9.
Patient perception of overall success: Currently, 279 (70%) patients rate their operation as a complete success, 86 (22%) as partially successful, and 35 (8%) as unsuccessful. Those with partial or no success cited recurrent reflux (n = 70), a side-effect (n = 37), or both (n = 14) as the reason.
2. Effects on esophageal function and mucosal integrity
Esophageal acid exposure: The average preoperative DeMeester (DM) score was 56.8 ± 48.1 (n = 320), which decreased to 16.0 ± 31 in patients who underwent postoperative testing between 1 month and 1 year (n = 149). Among 129 patients who had both preoperative and postoperative values available, 92 (71%) had normalization of a previous abnormal DM score whereas 114 (88%) had at least some improvement.
Mucosal integrity: Progression of Barrett's esophagus: Of the 58 patients with Barrett's esophagus before LARS, 2 developed high-grade dysplasia/cancer (or 1 per 258 patient years). Of 342 patients in our study without Barrett's esophagus before LARS, 9 developed Barrett's esophagus at a rate of 1 per 275 patient years (0.36% per year).
3. Need for additional Therapy
Medication use: 236 (59%) patients remain completely off medications for GERD, 164 (41%) are using antireflux medications. Of these, 73 (45%) patients are taking less medication than before LARS. The most common reasons for continuing GERD medication after LARS were heartburn (n = 100) 60%, regurgitation (n = 13) 8%, and Barrett's esophagus (n = 13) 8%.
Reoperations: Fifteen (3.7%) patients required reoperations, 9 for recurrent reflux and 6 for side-effects.
Conclusions: The success or failure of LARS cannot be defined in a single domain. A comprehensive analysis of outcomes requires categorization that includes symptom response, side-effects, patient's perception and objective measurement of acid exposure, mucosal integrity, and the need for additional medical or surgical treatment. Only then can patients and physicians better understand the role of LARS and make informed decisions.