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Prospective trial of laparoscopic Nissen fundoplication versus proton pump inhibitor therapy for gastro-oesophageal reflux disease: Seven year follow-up
Samir Mehta, John Bennett, David Mahon, Michael Rhodes; Department of Upper Gastrointestinal Surgery, Norfolk and Norwich University Hospital, Norwich, United Kingdom

Introduction Laparoscopic Nissen fundoplication and proton pump inhibitor (PPI) therapy are both established treatments for gastro-oesophageal reflux disease (GORD). We have performed a prospective randomised study comparing these two treatments (Br J Surg 2005;92:695-9) and now have long-term follow-up data. Methods Between July 1997 and August 2001, 217 patients took part in a randomised controlled trial comparing laparoscopic Nissen fundoplication and PPI therapy for the treatment of GORD. After a median of 6.9 years (range=4.3-8.3) patients from Norwich (84% of the cohort) were followed up and asked to complete a reflux symptom questionnaire. Results There were 91 patients in the surgery arm (Group 1) and 92 patients in the PPI arm. 54 patients randomised to PPI went on to have anti-reflux surgery after 12 months (Group 2a); the remaining 38 did not (Group 2b). 75% of patients responded to the postal questionnaire. Mean Demeester symptom scores (range 0-9) are shown in the table below: In all 3 groups there was a significant improvement in symptom score by 12 months (p<0.01 Mann-Whitney). However, patients in Group 2a experienced a further improvement following subsequent surgery (p<0.01) despite having had optimal PPI treatment beforehand. Conclusion Both optimal PPI therapy and laparoscopic Nissen fundoplication are effective and durable treatments for GORD. However, surgery offers additional benefit for those who have only partial symptomatic relief whilst on PPIs.

 

Description

n

Start

12 months

Median of 6.9 years

Group 1

Surgery

91

3.5

0.9

1.1

Group 2a

PPI then Surgery

54

3.3

2.3*

0.7*

Group 2b

PPI alone

38

2.4

1.1

0.9


* denotes difference in score is significant (Mann-Whitney test p<0.01)


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