Short note

40

Ten-year audit of randomized trials in 35 Europe

USA
30
digestive surgery from Europe

No. of trials
25
20
K. Slim, M. Haugh*, P.-L. Fagniez, D. Pezet and
15
J. Chipponi
10
Department of General and Digestive Surgery, Hotel-Dieu, University 5
Hospital of Clermont-Ferrand, Clermont-Ferrand, *French Cochrane 0
Centre, Centre Leon Berard, Lyons and Department of Digestive 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999
Surgery, Hospital Henri Mondor, Creteil, France
Correspondence to: Dr K. Slim, Department of General and Digestive Fig. 1 Evolution of the number of trials per year over the past
Surgery, Hotel-Dieu, Boulevard Leon Malfreyt, F-63058, decade in the eld of digestive surgery in Europe and the USA
Clermont-Ferrand Cedex 1, France

Paper accepted 2 May 2000 Table 1Number of trials (with their category) for each
European country and the respective number per million
inhabitants
Randomized trials remain scarce in the eld of digestive
surgical investigation because they present unique features Category No. of trials
and problems1. This study was a review of randomized trials Total no. per million
in the eld of digestive surgery to assess the evolution in Country 1 2 3 of trials inhabitants
Europe over the past decade.
UK 20 22 9 51 08
France 12 18 8 38 07
Materials and methods Germany 14 15 5 34 05
A comprehensive computerized search was conducted in Sweden 9 10 3 22 28
Finland 2 16 2 20 40
three databases (Medline, Embase and the Cochrane
Italy 3 13 1 17 03
Library) between 1 January 1990 and 31 December 1999. Netherlands 6 6 4 16 10
A manual search was also performed in the past six issues of Spain 2 8 4 14 04
14 major journals (American Journal of Surgery, Annals of Denmark 8 3 1 12 24
Other 10 13 4 27 03
Surgery, Archives of Surgery, British Medical Journal, British Whole of Europe 86 124 41 251 06
Journal of Surgery, Diseases of the Colon and Rectum, European
Journal of Surgery, Gastroenterology, Gut, Journal of the
American College of Surgeons, Lancet, New England Journal of
Medicine, Surgical Endoscopy, Surgery). Only original articles Finland in 20 and other countries in 82. There were four
comparing two surgical procedures or a surgical and a non- international multicentre trials. When the contribution of
surgical treatment were retained. When the authors were each country was calculated per million inhabitants, the
from different countries, the trial was considered as number of randomized trials was signicantly higher in the
international. Nordic countries, namely Finland, Sweden and Denmark
The trials were classied into three categories: category (Table 1). Although the number of trials of conventional
1, trials evaluating the core procedure itself (similar to surgical procedures remained stable (mean about 15 per
drugs); category 2, trials evaluating an important step of the year), the observed increase was due to trials evaluating
surgical procedure; and category 3, trials evaluating a laparoscopic procedures (almost half of the published trials
technical detail. over the past 4 years). For the whole of Europe, 210 trials
(84 per cent) were in category 1 or 2 (Table 1). In the whole
Results sample, 22 per cent of the trials were multicentre; in France
Two hundred and fty-one trials were retrieved (approxi- 59 per cent of the trials were multicentre with a range in the
mately two trials published per month). Fig. 1 shows the other countries from 7 per cent in Spain to 33 per cent in the
evolution of the number of trials per year in Europe Netherlands.
compared with that in North America, where 52 trials were
recorded over the same interval (references for all these Discussion
trials can be obtained from the author for correspondence). This study showed that European digestive surgeons
The UK was the country of afliation in 51 trials (20 per design, conduct and publish increasing numbers of
cent of trials), France in 38, Germany in 34, Sweden in 22, randomized trials, mainly since the introduction of laparo-

2000 Blackwell Science Ltd British Journal of Surgery 2000, 87, 15851586 1585
1586 Short note K. Slim, M. Haugh, P.-L. Fagniez, D. Pezet and J. Chipponi

scopic surgery. Using the approach described it was not
possible to ascertain how many trials were incomplete,
abandoned or unpublished. In all areas of clinical research
there is increasing awareness of the necessity to register all
clinical trials to avoid a publication bias2. The rarity of
multicentre trials should also be addressed since the
advantages of multicentre trials are recognized: the broader
range of patients and surgeons facilitates the generalization
of results and improved national and international colla-
boration3. The present results also showed how the
distribution of trials performed in different countries was
heterogeneous. In absolute terms, three countries provided
the most: the UK, France and Germany. However, when
this was calculated with respect to potential participants, the
Nordic countries provided the highest rate of trials. One can
speculate about the reasons for these ndings. The Nordic
countries may be more committed to evaluation than
others, or perhaps Nordic patients are more willing to
participate in clinical trials. The apparent increasing
enthusiasm of European digestive surgeons should be built
upon, and they should be encouraged to perform high-
quality randomized (particularly multicentre) trials.
Acknowledgements
The authors thank Mrs Souha Slim for help in collecting
the data.
References
1 McLeod RS, Wright JG, Solomon MJ, Hu X, Walters BC,
Lossing AI. Randomized controlled trials in surgery: issues and
problems. Surgery 1996; 119: 4836.
2 Dickersin K, Min YI. Publication bias: the problem that won't
go away. Ann N Y Acad Sci 1993; 703: 13548.
3 Warlow C. Organise a multicentre trial. BMJ 1990; 300: 1803.

Randomized clinical trials in surgery

The Journal acknowledges the growth in evidence-based surgical practice and wishes to
encourage clinical research in surgery. Randomized clinical trials have been awarded
priority at the beginning of the Journal. We also review the contents lists of the worlds'
top 50 surgical journals; randomized trials identied are featured on the Scientic
Surgery page at the back of the Journal. These trials are archived on the BJS website
(www.bjs.co.uk), where over 300 trials have been collected since the beginning of 1998.
If any signicant randomized clinical trials have been missed, please let us know and we
can add them to the archive. Authors of randomized clinical trials in surgery should
remember that they can request fast track publication in the British Journal of Surgery.

The Editors

British Journal of Surgery 2000, 87, 15851586 www.bjs.co.uk 2000 Blackwell Science Ltd