[Results of randomised clinical trial: not necessarily positively received].
The acceptance for publication and the implementation of the results of a randomised clinical trial are determined not only by the quality of the study, but also by its timing and the prevailing opinion prior to the study. In a randomised study, comparing laparoscopic and open fundoplication in patients with gastro-oesophageal reflux, interim analysis showed statistically significantly more complications related to laparoscopic intervention. Publication of the study led to an avalanche of criticism focusing mainly on the inexperience of the surgeons. The cost-effectiveness analysis, showing that open fundoplication had fewer complications and was cheaper, was repeatedly rejected by established journals mainly because of criticism of surgical aspects of the study. In the meanwhile a study on a second group of 100 patients was initiated. They underwent laparoscopic fundoplication conducted by two experienced surgeons. The results were statistically significantly better than in the laparoscopic arm of the initial randomised trial. The learning curve proved to be longer than had previously been thought.
Gooszen
H G
HG
Universitair Medisch Centrum Utrecht, Afd. Heelkunde, Postbus 85.5oo, 3508 GA Utrecht.
Simmermacher
R K J
RK
Van Der Graaf
Y
Y
D002983:Clinical Competence; D003627:Data Interpretation, Statistical; D018662:Fundoplication / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
Gerandomiseerd klinisch onderzoek: niet per se positieve ontvangst.