Superiority was no longer attainable
SELECT
Perioperative Selective Decontamination of the Digestive Tract (SDD) in Elective Colorectal Cancer Patients: a Multicenter Randomized Clinical Trial
Sponsor study identifier
interventional
485
1 country
5
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2017
Actual (reported)Study Completion
March 2017
Actual (reported)The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce clinical anastomotic leakage rate and its septic consequences as well as other infectious complications. By reduction of septic complications long-term oncological outcome might simultaneously improve.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2012
Actual (reported)December 4, 2012
Actual (reported)January 2013
Date type not reportedThis date has not been verified as actual or estimated.
March 2017
Actual (reported)March 2017
Actual (reported)anastomotic leakage and/or abscess
clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention.
30 days postoperatively
Disease free survival
3 and 5 years after inclusion
Other postoperative infectious complications
30 days postoperatively
Non-infectious complications
30 days postoperatively
In-hospital mortality
30 days postoperatively
Standard treatment for colorectal cancer
Standard treatment + SDD perioperatively 4 times daily 10 ml of SDD suspension, consisting of 100mg colistin sulfate, 80mg tobramycin and 500mg of amphotericin B. SDD treatment starts 3 days before surgery and is continued until at least 3 days postoperatively.
SDD suspension contains per dose of 10 ml 100 mg colistin sulfate, 80 mg tobramycin and 500 mg amphotericin B
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Slotervaart Ziekenhuis
Amsterdam, Netherlands
VU University Medical Center
Amsterdam, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
WestFries Gasthuis
Hoorn, Netherlands
Abis GSA, Stockmann HBAC, Bonjer HJ, van Veenendaal N, van Doorn-Schepens MLM, Budding AE, Wilschut JA, van Egmond M, Oosterling SJ; SELECT trial study group. Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial). Br J Surg. 2019 Mar;106(4):355-363. doi: 10.1002/bjs.11117. Epub 2019 Feb 25.
Abis GS, Oosterling SJ, Stockmann HB, van der Bij GJ, van Egmond M, Vandenbroucke-Grauls CM, Bonjer HJ. Perioperative selective decontamination of the digestive tract and standard antibiotic prophylaxis versus standard antibiotic prophylaxis alone in elective colorectal cancer patients. Dan Med J. 2014 Apr;61(4):A4695.
H.J. Bonjer, Md, PhD, FRCSC
Amsterdam UMC, location VUmc
G.S.A. Abis, MD, MSc
Amsterdam UMC, location VUmc
485 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2012
First Posted
December 4, 2012
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2017
Actual (reported)Study Completion
March 2017
Actual (reported)Last Updated
November 9, 2018
Record last verified: 2018-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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