Randomized clinical trial of perioperative selective decontamination of the digestive tract versus placebo in elective gastrointestinal surgery

  • Author: D. Roos, L. M. Dijksman, H. M. Oudemans‐van Straaten, L. T. de Wit, D. J. Gouma, M. F. Gerhards

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Sir,

We have read with great interest the article by Roos et al., reporting a double-blind randomized clinical trial comparing perioperative selective decontamination of the digestive tract versus placebo in elective gastrointestinal surgery.

The Authors reported a lower postoperative complication rate in the treatment group; specifically, they reported lower infectious complications and an impressive 58% relative reduction in anastomotic leakage.

Despite the strong clinical relevance of these findings, we believe that the Authors’ conclusions are not supported by statistical analysis, the study being severely underpowered. Analysing sample size in respect of the primary endpoint, namely a reduction of infectious complications from 30.8% in the placebo group to 19.6% in the treatment group, the power of the study becomes less than 60% (59.2%), clearly ineffective to support any definitive conclusions.

Another limitation of the study is to include patients undergoing different types of surgery, with different expected rates of anastomotic leakage. In colorectal surgery, anastomotic leaks represent one of the most feared postoperative complications, with a reported incidence ranging between 2.5% and 20% (1, 2). Moreover, in the study by Roos and colleagues, patients undergoing colorectal surgery were mechanically prepared, and we believe that this fact may modify the effects of decontaminant agents. The role of mechanical bowel preparation has been questioned by recent meta-analysis and its use progressively abandoned by many colorectal centres (3, 4).

Therefore, the Authors’ conclusions suggesting perioperative selective decontamination of the digestive tract should be read with caution, until larger studies specifically based on colorectal procedures are available.

Mario Morino, Gitana Scozzari
Digestive, Colorectal and Minimal Invasive Surgery, Department of Surgery, University of Torino, Italy
mario.morino@unito.it

References

1. Borowski DW, Bradburn DM, Mills SJ, Bharathan B, Wilson RG, Ratcliffe AA, et al. Volume-outcome analysis of colorectal cancer-related outcomes. Br J Surg 2010;97:1416-30

2. Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg 2011;253:890-9

3. Slim K, Vicaut E, Launay-Savary MV, Contant C, Chipponi J. Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery. Ann Surg 2009;249:203-9

4. Güenaga KF, Matos D, Wille-Jørgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev 2011 Sep 7;9:CD001544

  • Commentor: Mario Morino, Gitana Scozzari - University of Torino, Italy
  • Date: Dec 20, 2011