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

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ClinicalTrials.gov Identifier: NCT01740947
Recruitment Status : Terminated (Superiority was no longer attainable)
First Posted : December 4, 2012
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Dutch Digestive Diseases Foundation
Information provided by (Responsible Party):
H. Jaap Bonjer, PhD, VU University Medical Center

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B) Phase 4

Detailed Description:

Rationale:

Infectious complications and especially anastomotic leakage severely impede the recuperation of patients following colorectal cancer surgery. When the normal gut barrier fails such as in anastomotic leakage, pathogenic microorganisms like Gram-negative bacteria enter the circulation and may cause severe sepsis which is associated with considerable mortality. Moreover, anastomotic leakage has a negative impact on colorectal cancer prognosis. Selective decontamination of the digestive tract (SDD) is a prophylaxis regimen that employs oral nonabsorbable antibiotics to eradicate pathogenic micro-organisms like Gram-negative bacteria.

Objective:

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. Secondary objectives are a decline in reoperation rate, in-hospital mortality, readmission rate, duration of hospital stay and ICU admission, non-infectious complications, improvement of quality of life and reduction of costs.

Study design:

A randomised multicenter clinical trial comparing perioperative SDD in addition to standard antibiotic prophylaxis with standard antibiotic prophylaxis alone in patients with colorectal cancer who undergo elective surgical resection with curative intent.

Study population:

Patients 18 years or older are eligible for inclusion when they are diagnosed with colon or rectal cancer without signs of distant metastases. Patients may be scheduled for either laparoscopic or open resection with curative intent, including construction of an anastomosis (either with or without diverting stoma). Patients are not eligible for inclusion in case of concomitant metastases or acute obstruction.

Intervention:

Patients are randomly allocated for either perioperative SDD (intervention group) including standard antibiotic prophylaxis or standard treatment (including standard antibiotic prophylaxis alone) (control group). The solution containing SDD is orally taken 4 times daily, starting 3 days before surgery and continued until normal bowel passage or at least 3 days after surgery. Both groups receive a single preoperative intravenous dose of 1000 mg Cefazoline and 500 mg Metronidazole, which is the current standard antibiotic prophylaxis.

Main study parameters/endpoints:

The main study parameter is anastomotic leakage. The research hypothesis refers to an estimated decrease in anastomotic leakage rate in the SDD treated group (from 9% to 4%). As anastomotic leakage has been shown unfavourable forlong term oncological outcome, we presume an improvement in disease free survival, which serves as important secondary endpoint.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Perioperative Selective Decontamination of the Digestive Tract (SDD) in Elective Colorectal Cancer Patients: a Multicenter Randomized Clinical Trial
Study Start Date : January 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017


Arm Intervention/treatment
No Intervention: Standard treatment
Standard treatment for colorectal cancer
Experimental: Selective decontamination of the digestive tract (SDD)

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




Primary Outcome Measures :
  1. anastomotic leakage and/or abscess [ Time Frame: 30 days postoperatively ]
    clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention.


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 and 5 years after inclusion ]

Other Outcome Measures:
  1. Other postoperative infectious complications [ Time Frame: 30 days postoperatively ]
    pneumonia, urinary tract infections, surgical site infections, wound dehiscence, (remote) intraabdominal abscess

  2. Non-infectious complications [ Time Frame: 30 days postoperatively ]
    cardiac failure, cerebrovascular events, deep venous thrombosis

  3. In-hospital mortality [ Time Frame: 30 days postoperatively ]
  4. Readmission rate [ Time Frame: 5 years postoperatively ]
  5. Reoperation rate [ Time Frame: 5 years postoperatively ]
  6. Duration of hospital stay [ Time Frame: 30 days postoperatively ]
  7. Quality of life (quality adjusted life years) [ Time Frame: 2 years postoperatively ]
  8. In hospital and out-of-hospital costs [ Time Frame: 5 years postoperatively ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740947


Locations
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Netherlands
Slotervaart Ziekenhuis
Amsterdam, Netherlands
VU University Medical Center
Amsterdam, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
WestFries Gasthuis
Hoorn, Netherlands
Sponsors and Collaborators
H. Jaap Bonjer, PhD
Dutch Digestive Diseases Foundation
Investigators
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Principal Investigator: H.J. Bonjer, Md, PhD, FRCSC VU University Medical Center
Study Director: G.S.A. Abis, MD, MSc VU University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: H. Jaap Bonjer, PhD, Professor of Surgery, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01740947     History of Changes
Other Study ID Numbers: 2011-002211-28
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Keywords provided by H. Jaap Bonjer, PhD, VU University Medical Center:
Selective decontamination of the digestive tract
anastomotic leakage
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Tobramycin
Amphotericin B
Colistin
Liposomal amphotericin B
Anti-Bacterial Agents
Anti-Infective Agents
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents