Five-year follow-up of a multicenter, double-blind randomized clinical trial of laparoscopic Nissen vs anterior 90 degrees partial fundoplication.
OBJECTIVE
Laparoscopic 90 degrees anterior partial fundoplication for gastroesophageal reflux disease achieves equivalent results to laparoscopic Nissen fundoplication.


METHODS
A multicenter, prospective, double-blind randomized clinical trial with a minimum of 5 years' follow-up.


METHODS
Nine university teaching hospitals in 6 major cities throughout Australia and New Zealand.


METHODS
One hundred twelve patients undergoing primary antireflux surgery were randomized to undergo either laparoscopic Nissen fundoplication (52 patients) or anterior 90 degrees partial fundoplication (60 patients).


METHODS
Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication.


METHODS
Blinded assessment at 1 and 5 years' follow-up of clinical outcome for postoperative heartburn, dysphagia, gas-related symptoms, and satisfaction with the surgical outcome. Analog scales ranging from 0 to 10 were used to assess symptom severity.


RESULTS
Ninety-seven patients underwent follow-up at 5 years. Three others died during follow-up, 4 refused follow-up, and 8 were lost to follow-up; 89% remained at 5-years' follow-up. At 5 years' follow-up, mean analog scores for heartburn were 2.2 for anterior fundoplication vs 0.9 for Nissen fundoplication (P=.003). There were no significant differences between the groups for dysphagia scores. The mean score for outcome satisfaction was 7.1 after anterior fundoplication vs 8.1 after Nissen fundoplication (P=.18). Eighty-eight percent reported a good or excellent outcome following Nissen fundoplication vs 77% following anterior fundoplication.


CONCLUSIONS
Laparoscopic Nissen and anterior 90 degrees partial fundoplication achieve similar levels of patient satisfaction at 5 years' follow-up, with similar adverse effect profiles. However, at 5 years' follow-up, laparoscopic Nissen fundoplication achieves superior control of reflux symptoms.


BACKGROUND
Australian New Zealand Clinical Trials Register Identifier: ACTRN12607000298415.
Nijjar
Rajwinder S
RS
University of Adelaide, Adelaide, South Australia.
Watson
David I
DI
Jamieson
Glyn G
GG
Archer
Stephen
S
Bessell
Justin R
JR
Booth
Michael
M
Cade
Richard
R
Cullingford
Graham L
GL
Devitt
Peter G
PG
Fletcher
David R
DR
Hurley
James
J
Kiroff
George
G
Martin
Ian J G
IJ
Nathanson
Leslie K
LK
Windsor
John A
JA
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000009:adverse effects / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000601:surgery*; D006356:Heartburn / Q000175:diagnosis / Q000453:epidemiology; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D011446:Prospective Studies; D012008:Recurrence; D012016:Reference Values; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome