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Does Administration of Antibiotics in Patients Undergoing Surgery for Colorectal Cancer Result in Less Complications and Better Prognosis?

NCT01740947 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 485

Last updated 2018-11-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)

SDD suspension contains per dose of 10 ml 100 mg colistin sulfate, 80 mg tobramycin and 500 mg amphotericin B

Sponsors & Collaborators

  • Dutch Digestive Diseases Foundation

    collaborator OTHER

  • H. Jaap Bonjer, PhD

    lead OTHER

Principal Investigators

  • H.J. Bonjer, Md, PhD, FRCSC · Amsterdam UMC, location VUmc

  • G.S.A. Abis, MD, MSc · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01740947 on ClinicalTrials.gov