Original article
General thoracic
Fifteen-Year Outcome of Laparoscopic and Open Nissen Fundoplication: A Randomized Clinical Trial

https://doi.org/10.1016/j.athoracsur.2011.08.066Get rights and content

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.

Section snippets

Patients and Methods

Between April 1992 and June 1995, 110 consecutive patients at our institution were randomized to undergo either LNF or conventional ONF, with 55 patients undergoing each procedure. The clinical details of the patients and the operative techniques have previously been described [2]. We have also previously reported subjective and objective outcomes of the two techniques in an 11-year follow-up of the patients. [16] The study was approved by the Turku University Hospital District ethics committee

Results

The objective endoscopic and clinical findings and subjective symptomatic outcomes in the study were in agreement with those in our previously reported 11-year investigation of outcome in the study population. There was a somewhat decreasing trend toward diminished dysphagia, in that only 42 patients (50.6%) in the 11-year follow-up reported the absence of dysphagia, whereas in the present 15-year follow-up 56 patients (67.5%) were asymptomatic for dysphagia (p = 0.0793). There was an

Comment

Laparoscopic Nissen fundoplication rapidly became the surgical procedure of choice in the operative treatment of GERD even before publication of the 1-year follow-up results of the first randomized trial comparing LNF and ONF [2]. This development occurred on the basis of early results that showed a lower morbidity with LNF than with ONF, accompanied by an equivalently high rate of patient satisfaction [20, 21, 22]. Besides our own comparative study of LNF and ONF, only one other randomized

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