Laparoscopic fundoplication: a model for assessing new technology in surgical procedures

BACKGROUND: Surgical success has traditionally been judged from the surgeon's perspective. A more complete evaluation of outcome incorporates the patient's, surgeon's, and payor's perspectives. Because gastroesophageal reflux disease (GERD) is primarily a quality-of-life (QOL) problem, the evaluation of laparoscopic fundoplication (LF) is a useful model for evaluating outcomes from these 3 perspectives. METHODS: Between 1995 and 2000, 74 patients underwent primary LF for GERD. In addition to undergoing physiologic testing, 63 patients (85%) were evaluated with use of a disease-specific health-related QOL scale (GERD-HRQL), scored from 0 (no symptoms) to 45 (incapacitating symptoms). Thirty-three patients also completed a generic QOL questionnaire (SF-12), in which patient satisfaction was scored from 1 (very satisfied) to 5 (very dissatisfied). Preoperative and postoperative data were compared with use of the Wilcoxon signed rank test or the paired t test. RESULTS: The median GERD-HRQL score improved from 18 to 0 at 2 years postoperation (P <.01). The median satisfaction score improved from 5 to 1 (P <.01). The SF-12 summary scores also improved after 6 weeks postoperatively (P <.05). The mean +/- SD lower esophageal sphincter pressure rose from 7.3 +/- 4 mm Hg preoperatively to 17.5 +/- 6 postoperatively (P <.01), and the mean percentage of time that the esophagus was exposed to a pH of less than 4 declined from 14.7% +/- 12% to 1.1% +/- 2% (P <.01). The median operative time was 110 minutes, which declined with experience with the procedure (P <.01). Median postoperative stay was 2 days. CONCLUSIONS: In evaluating the outcomes of a new procedure, 3 overlapping points of view were addressed: the patient's (QOL, satisfaction), the surgeon's (physiologic changes), and the payor's (operating room time, hospital stay). With use of this framework, we found that LF for GERD improves QOL, corrects the physiologic abnormalities, and is associated with short hospitalization and operating time that declines with experience with the procedure.