Fifteen-year outcome of laparoscopic and open Nissen fundoplication: a randomized clinical trial.

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) has become the method of choice in the surgical treatment of gastroesophageal reflux disease (GERD), replacing its open counterpart without confirmation by the long-term results of controlled clinical studies. The goal of the present study was to compare the 15-year outcome of a randomized controlled comparison study of LNF versus open Nissen fundoplication (ONF).

METHODS: From 1992 to 1995, 110 consecutive patients were randomized to undergo LNF or ONF. The 15-year objective results were evaluated by endoscopy, and the subjective symptomatic outcome was assessed by interviews.

RESULTS: A total of 86 patients (48 in the LNF [LAP] and 38 in the ONF [OPEN] group) participated in the study. The late long-term symptomatic outcome was similar in the two patient groups. In the LAP group, 91.7% of the patients gave a positive evaluation of their surgical result, as compared with 76.3% of the patients in the OPEN group (p=0.0484). A significantly greater number of disrupted plications (p=0.0115) and incisional hernias (p<0.001) occurred in the OPEN than in the LAP group. Both the subjective outcome and the objective endoscopic and clinical findings in the present study were in accord with our previously reported outcomes at 11-years after laparoscopic versus open fundoplication. The study found a trend toward (p=0.0851) an increasing need for the regular use of a proton pump inhibitor with the passage of time after Nissen fundoplication.

CONCLUSIONS: The 15-year results obtained in the present study define laparoscopic Nissen fundoplication as the procedure of choice in the surgical management of GERD. The long-term symptomatic outcomes of open and laparoscopic Nissen fundoplication appear to remain unaltered after the first 10 postoperative years.