Colorectal CancerPhase 4SELECTNCT01740947
Does Administration of Antibiotics in Patients Undergoing Surgery for Colorectal Cancer Result in Less Complications and Better Prognosis?
A Phase 4 study testing Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B) in people with Colorectal Cancer, run by H. Jaap Bonjer, PhD at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 5 sitesNetherlands
- Study dates
- Jan 2013to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Slotervaart Ziekenhuis
Amsterdam
VU University Medical Center
Amsterdam
Kennemer Gasthuis
Haarlem
Spaarne Ziekenhuis
Hoofddorp
WestFries Gasthuis
Hoorn
About this study
Official title: Perioperative Selective Decontamination of the Digestive Tract (SDD) in Elective Colorectal Cancer Patients: a Multicenter Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)
- Keywords
- Selective decontamination of the digestive tract, anastomotic leakage, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)Drug
Also called SDD
SDD suspension contains per dose of 10 ml 100 mg colistin sulfate, 80 mg tobramycin and 500 mg amphotericin B
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leakage and/or abscess
clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention.
Measured: 30 days postoperatively
Secondary outcomes (1)
Disease free survival
Measured: 3 and 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Superiority was no longer attainable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Jaap Bonjer, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Digestive Diseases Foundation
- Responsible party
- Sponsor-investigator, H. Jaap Bonjer, PhD, Amsterdam UMC, location VUmc
- Investigators
- H.J. Bonjer, Md, PhD, FRCSC, Principal investigator, Amsterdam UMC, location VUmcG.S.A. Abis, MD, MSc, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740947
- Sponsor's protocol ID
- 2011-002211-28
- Acronym
- SELECT
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2012
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30802304Abis 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.
PubMed 24814583
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Selective Decontamination of the Digestive Tract (SDD) in Elective Colorectal Cancer Patients: a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01740947
- Acronym / sponsor ID
- SELECT / 2011-002211-28
- Conditions
- Colorectal Cancer
- Keywords
- Selective decontamination of the digestive tract, anastomotic leakage, colorectal cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Superiority was no longer attainable
- Enrolment
- 485 participants (actual)
- Lead sponsor
- H. Jaap Bonjer, PhDUniversity, hospital or other
- Collaborators
- Dutch Digestive Diseases Foundation
- Study start
- Jan 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –Standard treatment for colorectal cancer |
| Selective decontamination of the digestive tract (SDD) | Experimental | Drug: Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)Also: SDDSDD suspension contains per dose of 10 ml 100 mg colistin sulfate, 80 mg tobramycin and 500 mg amphotericin B | Drug | Selective decontamination of the digestive tract (SDD) |
Primary outcome
anastomotic leakage and/or abscess
Time frame: 30 days postoperatively
clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention.
1 secondary outcome
Disease free survival
Time frame: 3 and 5 years after inclusion
Results and safety
The study was stopped early (reason given: Superiority was no longer attainable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Derived from this study: PubMed 30802304Abis 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.
- Derived from this study: PubMed 24814583Abis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H.J. Bonjer, Md, PhD, FRCSC principal investigator
Amsterdam UMC, location VUmc
G.S.A. Abis, MD, MSc study director
Amsterdam UMC, location VUmc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B) in people with Colorectal Cancer, run by H. Jaap Bonjer, PhD at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Superiority was no longer attainable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leakage and/or abscess (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01740947, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.