Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial)

the SELECT trial study group, G. S. A. Abis, H. B. A. C. Stockmann, H. J. Bonjer, N. van Veenendaal, M. L. M. van Doorn-Schepens, A. E. Budding, J. A. Wilschut, M. van Egmond, S. J. Oosterling, G. S. A. Abis, H. J. Bonjer, N. van Veenendaal, M. L. M. van Doorn-Schepens, A. E. Budding, E. S. M. de Lange, J. B. Tuynman, C. M. J. e. Vandenbroucke-Grauls, J. A. Wilschut, M. van Egmond & 26 others H. B. A. C. Stockmann, G. J. van der Bij, N. de Korte, S. J. Oosterling, Y. I. Z. Acherman, F. C. den Boer, D. J. A. Sonneveld, L. Poort, G. S. A. Abis, H. J. Bonjer, N. van Veenendaal, M. L. M. van Doorn-Schepens, A. E. Budding, E. S. M. de Lange, J. B. Tuynman, C. M. J. e Vandenbroucke-Grauls, J. A. Wilschut, M. van Egmond, H. B. A. C Stockmann, G. J. van der Bij, N. de Korte, S. J. Oosterling, Y. I. Z. Acherman, F. C. den Boer, D. J. A. Sonneveld, L. Poort

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: Infectious complications and anastomotic leakage affect approximately 30 per cent of patients after colorectal cancer surgery. The aim of this multicentre randomized trial was to investigate whether selective decontamination of the digestive tract (SDD) reduces these complications of elective colorectal cancer surgery. Methods: The effectiveness of SDD was evaluated in a multicentre, open-label RCT in six centres in the Netherlands. Patients with colorectal cancer scheduled for elective curative surgery with a primary anastomosis were eligible. Oral colistin, tobramycin and amphotericin B were administered to patients in the SDD group to decontaminate the digestive tract. Both treatment and control group received intravenous cefazolin and metronidazole for perioperative prophylaxis. Mechanical bowel preparation was given for left-sided colectomies, sigmoid and anterior resections. Anastomotic leakage was the primary outcome; infectious complications and mortality were secondary outcomes. Results: The outcomes for 228 patients randomized to the SDD group and 227 randomized to the control group were analysed. The trial was stopped after interim analysis demonstrated that superiority was no longer attainable. Effective SDD was confirmed by interspace DNA profiling analysis of rectal swabs. Anastomotic leakage was observed in 14 patients (6·1 per cent) in the SDD group and in 22 patients (9·7 per cent) in the control group (odds ratio (OR) 0·61, 95 per cent c.i. 0·30 to 1·22). Fewer patients in the SDD group had one or more infectious complications than patients in the control group (14·9 versus 26·9 per cent respectively; OR 0·48, 0·30 to 0·76). Multivariable analysis indicated that SDD reduced the rate of infectious complications (OR 0·47, 0·29 to 0·76). Conclusion: SDD reduces infectious complications after colorectal cancer resection but did not significantly reduce anastomotic leakage in this trial. Registration number: NCT01740947 (https://www.clinicaltrials.gov).
LanguageEnglish
JournalBritish Journal of Surgery
DOIs
Publication statusPublished - 2019

Cite this

@article{2b7f91d6a3cb428697248f1a8ebe8629,
title = "Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial)",
abstract = "Background: Infectious complications and anastomotic leakage affect approximately 30 per cent of patients after colorectal cancer surgery. The aim of this multicentre randomized trial was to investigate whether selective decontamination of the digestive tract (SDD) reduces these complications of elective colorectal cancer surgery. Methods: The effectiveness of SDD was evaluated in a multicentre, open-label RCT in six centres in the Netherlands. Patients with colorectal cancer scheduled for elective curative surgery with a primary anastomosis were eligible. Oral colistin, tobramycin and amphotericin B were administered to patients in the SDD group to decontaminate the digestive tract. Both treatment and control group received intravenous cefazolin and metronidazole for perioperative prophylaxis. Mechanical bowel preparation was given for left-sided colectomies, sigmoid and anterior resections. Anastomotic leakage was the primary outcome; infectious complications and mortality were secondary outcomes. Results: The outcomes for 228 patients randomized to the SDD group and 227 randomized to the control group were analysed. The trial was stopped after interim analysis demonstrated that superiority was no longer attainable. Effective SDD was confirmed by interspace DNA profiling analysis of rectal swabs. Anastomotic leakage was observed in 14 patients (6·1 per cent) in the SDD group and in 22 patients (9·7 per cent) in the control group (odds ratio (OR) 0·61, 95 per cent c.i. 0·30 to 1·22). Fewer patients in the SDD group had one or more infectious complications than patients in the control group (14·9 versus 26·9 per cent respectively; OR 0·48, 0·30 to 0·76). Multivariable analysis indicated that SDD reduced the rate of infectious complications (OR 0·47, 0·29 to 0·76). Conclusion: SDD reduces infectious complications after colorectal cancer resection but did not significantly reduce anastomotic leakage in this trial. Registration number: NCT01740947 (https://www.clinicaltrials.gov).",
author = "{the SELECT trial study group} and Abis, {G. S. A.} and Stockmann, {H. B. A. C.} and Bonjer, {H. J.} and {van Veenendaal}, N. and {van Doorn-Schepens}, {M. L. M.} and Budding, {A. E.} and Wilschut, {J. A.} and {van Egmond}, M. and Oosterling, {S. J.} and Abis, {G. S. A.} and Bonjer, {H. J.} and {van Veenendaal}, N. and {van Doorn-Schepens}, {M. L. M.} and Budding, {A. E.} and {de Lange}, {E. S. M.} and Tuynman, {J. B.} and {e. Vandenbroucke-Grauls}, {C. M. J.} and Wilschut, {J. A.} and {van Egmond}, M. and {C. Stockmann}, {H. B. A.} and {van der Bij}, {G. J.} and {de Korte}, N. and Oosterling, {S. J.} and Acherman, {Y. I. Z.} and {den Boer}, {F. C.} and Sonneveld, {D. J. A.} and L. Poort and Abis, {G. S. A.} and Bonjer, {H. J.} and {van Veenendaal}, N. and {van Doorn-Schepens}, {M. L. M.} and Budding, {A. E.} and {de Lange}, {E. S. M.} and Tuynman, {J. B.} and {e Vandenbroucke-Grauls}, {C. M. J.} and Wilschut, {J. A.} and {van Egmond}, M. and {C Stockmann}, {H. B. A.} and {van der Bij}, {G. J.} and {de Korte}, N. and Oosterling, {S. J.} and Acherman, {Y. I. Z.} and {den Boer}, {F. C.} and Sonneveld, {D. J. A.} and L. Poort",
year = "2019",
doi = "10.1002/bjs.11117",
language = "English",
journal = "British Journal of Surgery",
issn = "0007-1323",
publisher = "John Wiley and Sons Ltd",

}

Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial). / the SELECT trial study group.

In: British Journal of Surgery, 2019.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial)

AU - the SELECT trial study group

AU - Abis, G. S. A.

AU - Stockmann, H. B. A. C.

AU - Bonjer, H. J.

AU - van Veenendaal, N.

AU - van Doorn-Schepens, M. L. M.

AU - Budding, A. E.

AU - Wilschut, J. A.

AU - van Egmond, M.

AU - Oosterling, S. J.

AU - Abis, G. S. A.

AU - Bonjer, H. J.

AU - van Veenendaal, N.

AU - van Doorn-Schepens, M. L. M.

AU - Budding, A. E.

AU - de Lange, E. S. M.

AU - Tuynman, J. B.

AU - e. Vandenbroucke-Grauls, C. M. J.

AU - Wilschut, J. A.

AU - van Egmond, M.

AU - C. Stockmann, H. B. A.

AU - van der Bij, G. J.

AU - de Korte, N.

AU - Oosterling, S. J.

AU - Acherman, Y. I. Z.

AU - den Boer, F. C.

AU - Sonneveld, D. J. A.

AU - Poort, L.

AU - Abis, G. S. A.

AU - Bonjer, H. J.

AU - van Veenendaal, N.

AU - van Doorn-Schepens, M. L. M.

AU - Budding, A. E.

AU - de Lange, E. S. M.

AU - Tuynman, J. B.

AU - e Vandenbroucke-Grauls, C. M. J.

AU - Wilschut, J. A.

AU - van Egmond, M.

AU - C Stockmann, H. B. A.

AU - van der Bij, G. J.

AU - de Korte, N.

AU - Oosterling, S. J.

AU - Acherman, Y. I. Z.

AU - den Boer, F. C.

AU - Sonneveld, D. J. A.

AU - Poort, L.

PY - 2019

Y1 - 2019

N2 - Background: Infectious complications and anastomotic leakage affect approximately 30 per cent of patients after colorectal cancer surgery. The aim of this multicentre randomized trial was to investigate whether selective decontamination of the digestive tract (SDD) reduces these complications of elective colorectal cancer surgery. Methods: The effectiveness of SDD was evaluated in a multicentre, open-label RCT in six centres in the Netherlands. Patients with colorectal cancer scheduled for elective curative surgery with a primary anastomosis were eligible. Oral colistin, tobramycin and amphotericin B were administered to patients in the SDD group to decontaminate the digestive tract. Both treatment and control group received intravenous cefazolin and metronidazole for perioperative prophylaxis. Mechanical bowel preparation was given for left-sided colectomies, sigmoid and anterior resections. Anastomotic leakage was the primary outcome; infectious complications and mortality were secondary outcomes. Results: The outcomes for 228 patients randomized to the SDD group and 227 randomized to the control group were analysed. The trial was stopped after interim analysis demonstrated that superiority was no longer attainable. Effective SDD was confirmed by interspace DNA profiling analysis of rectal swabs. Anastomotic leakage was observed in 14 patients (6·1 per cent) in the SDD group and in 22 patients (9·7 per cent) in the control group (odds ratio (OR) 0·61, 95 per cent c.i. 0·30 to 1·22). Fewer patients in the SDD group had one or more infectious complications than patients in the control group (14·9 versus 26·9 per cent respectively; OR 0·48, 0·30 to 0·76). Multivariable analysis indicated that SDD reduced the rate of infectious complications (OR 0·47, 0·29 to 0·76). Conclusion: SDD reduces infectious complications after colorectal cancer resection but did not significantly reduce anastomotic leakage in this trial. Registration number: NCT01740947 (https://www.clinicaltrials.gov).

AB - Background: Infectious complications and anastomotic leakage affect approximately 30 per cent of patients after colorectal cancer surgery. The aim of this multicentre randomized trial was to investigate whether selective decontamination of the digestive tract (SDD) reduces these complications of elective colorectal cancer surgery. Methods: The effectiveness of SDD was evaluated in a multicentre, open-label RCT in six centres in the Netherlands. Patients with colorectal cancer scheduled for elective curative surgery with a primary anastomosis were eligible. Oral colistin, tobramycin and amphotericin B were administered to patients in the SDD group to decontaminate the digestive tract. Both treatment and control group received intravenous cefazolin and metronidazole for perioperative prophylaxis. Mechanical bowel preparation was given for left-sided colectomies, sigmoid and anterior resections. Anastomotic leakage was the primary outcome; infectious complications and mortality were secondary outcomes. Results: The outcomes for 228 patients randomized to the SDD group and 227 randomized to the control group were analysed. The trial was stopped after interim analysis demonstrated that superiority was no longer attainable. Effective SDD was confirmed by interspace DNA profiling analysis of rectal swabs. Anastomotic leakage was observed in 14 patients (6·1 per cent) in the SDD group and in 22 patients (9·7 per cent) in the control group (odds ratio (OR) 0·61, 95 per cent c.i. 0·30 to 1·22). Fewer patients in the SDD group had one or more infectious complications than patients in the control group (14·9 versus 26·9 per cent respectively; OR 0·48, 0·30 to 0·76). Multivariable analysis indicated that SDD reduced the rate of infectious complications (OR 0·47, 0·29 to 0·76). Conclusion: SDD reduces infectious complications after colorectal cancer resection but did not significantly reduce anastomotic leakage in this trial. Registration number: NCT01740947 (https://www.clinicaltrials.gov).

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85062346340&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/30802304

U2 - 10.1002/bjs.11117

DO - 10.1002/bjs.11117

M3 - Article

JO - British Journal of Surgery

T2 - British Journal of Surgery

JF - British Journal of Surgery

SN - 0007-1323

ER -