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

NCT01740947 | Terminated Phase 4

• 1 other identifier: 2011-002211-28
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 5

Brief 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

Colorectal Cancer

Keywords

Selective decontamination of the digestive tract; anastomotic leakage; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• anastomotic leakage and/or abscess

  clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention.

  30 days postoperatively

Secondary Outcomes (1)

• Disease free survival

  3 and 5 years after inclusion

Other Outcomes (8)

• Other postoperative infectious complications

  30 days postoperatively

• Non-infectious complications

  30 days postoperatively

• In-hospital mortality

  30 days postoperatively

Study Arms (2)

Standard treatment

NO INTERVENTION

Standard treatment for colorectal cancer

Selective decontamination of the digestive tract (SDD)

EXPERIMENTAL

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.

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

Interventions

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

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

Also known as: SDD

Selective decontamination of the digestive tract (SDD)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective colon and rectal cancer surgery with primary anastomosis
• Or elective colorectal surgery for suspected carcinoma
• No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CTthorax)
• Procedure either with or without diverting stoma
• Both laparoscopic and open surgery
• Informed consent
• Aged 18 years or older

You may not qualify if:

• Previous colorectal malignancy
• Current malignancy which is now undergoing treatment
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• Previous surgery for diverticular disease
• Performance status ASA 4 or higher (American Society for Anaesthesiologists)
• Expected adverse reactions/allergies for study medication
• Prednisone use \> 5 mg per day
• Familial adenomatous polyposis coli (FAP; Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)
• Mental disorder/unable to give informed consent
• Pregnancy

Sponsors & Collaborators

• H. Jaap Bonjer, PhD: lead
• Dutch Digestive Diseases Foundation: collaborator

Study Sites (5)

Slotervaart Ziekenhuis

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Kennemer Gasthuis

Haarlem, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Location

WestFries Gasthuis

Hoorn, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 30802304 DERIVED

• 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.

  PMID: 24814583 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak

Interventions

Colistin; Tobramycin; Amphotericin B

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• H.J. Bonjer, Md, PhD, FRCSC

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• G.S.A. Abis, MD, MSc

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 9, 2018

Record last verified: 2018-11

Locations

NL (5)