Table 2 The characteristics of 10 RCTs

Yeo et al.

1995

United States

Controlled randomized, single-center trial

73/72

62/62

40/34

7.4/7.2

17.1/17.7

Radiographically documented leak or >50 mL drainage of amylase-rich fluid on or after postoperative day 10.

Duffas et al.

2005

France

Single-blind, controlled randomized, multicenter trial

81/68

58/59

30/33

6.5/6.4

20.0/21.0

Fluid obtained through drains or percutaneous aspiration, containing at least 4 times normal serum values of amylase for 3 days, confirmed by fistulography, by upper gastrointestinal hydrosoluble contrast or enhanced Ct scan.

Bassi et al.

2005

Italy

Controlled randomized, single-center trial

69/82

59/56

25/31

5.6/5.9

14.2/15.4

Any clinical significant output of fluid, rich in amylase, confirmed by fistulography.

Fernandez-Cruz et al.

2008

Spain

Controlled randomized, single-center trial

53/55

63/63

24/17

5.0/5.2

12.0/16.0

ISGPF definition

Wellner UF et al.

2012

Germany

Controlled randomized, single-center trial

59/57

67/64

32/28

6.7/7.4

15.0/17.0

ISGPF definition

Topal et al.

2013

Belgium

Single blind, controlled randomized,multicenter trial

162/167

67/66

76/62

4.2/4.2

19.0/17.0

ISGPF definition

Figueras et al

2013

Spain

Single blind, controlled randomized, single-center trial

65/58

67/66

21/21

5.5/5.1

12.0/15.5

ISGPF definition

Grendar et al.

2014

Canada

Double blind, controlled randomized, single-center trial

48/50

64/68

28/21

5.8/5.9

17.4/14.0

Radiologically proven anastomotic leak or continued drainage (via drain, enterocutaneous fistula or wound) of lipase-rich fluid on postoperative day 10.

El Nakeeb et al.

2014

Egypt

Single-blind, controlled randomized, single-center trial

45/45

58/54

22/18

5.0/5.3

9.0/8.0

ISGPF definition

Keck et al.

2016

Germany

Single-blind, controlled randomized, multicenter trial

171/149

68/66

67/56

5.5/5.6

15.0/16.0

ISGPF definition