Spinal Cord InjuryNCT00856440
Safety and Efficacy of Routine Colonoscopy Preparations
An observational study of Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Fleets Oral Sodium Phosphate Solution (OSPS), Colyte and Dual (OSPS & Colyte)
- Type of treatment
- Pill or oral medicine
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans, SCI and able-bodied
Who may be able to join
- 1. Patients already clinically indicated for colonoscopy examination
Who cannot join
- Patients who are not a candidate for elective colonoscopy (i.e. those with recent myocardial infarction, terminal illness, etc.)
- Patients who have a contraindication for Colyte (i.e. those with colonic obstruction, etc.)
- Patients who have a contraindication for Fleet OSPS (i.e. those with poor renal function, class 2 or greater symptomatic heart failure, etc.)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
Read the detailed description
Colonoscopy is a routine evaluation for screening of colorectal cancer in people over 50 and for those at increased genetic risk. Despite the large number of individuals requiring such screening, there has been little randomized, controlled research to determine the relative renal safety of oral colon preparation solutions that are used to evacuate the bowel in patients with "normal" kidney function, the best frequency of laxative dosing (e.g. 1 day vs. 2 day), and the quality of the colon cleansing that results from these different approaches. Reports of acute renal failure, secondary to nephrocalcinosis, following the commonly used oral phosphosoda preparation are increasingly recognized. It is our belief that this project will yield clinically relevant information that would have immediate clinical application for all persons receiving a colonoscopy. Since preparation for screening colonoscopy involves vigorous purging of stool from individuals without GI complaints, it also represents an opportunity to study the prevalence of clostridium difficile (C. diff) in this population. This may reveal important information regarding the epidemiology of this increasingly virulent and common enteric pathogen. A pilot screening program for asymptomatic C. diff, a common nosocomial pathogen, may reveal findings of clinical importance for preventing spread of this infection, and allow use of presumptive treatment during periods of increased risk.
- Conditions
- Spinal Cord Injury
- Being tested
- Fleets Oral Sodium Phosphate Solution (OSPS), Colyte, Dual (OSPS & Colyte)
- Keywords
- SCI
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fleets Oral Sodium Phosphate Solution (OSPS)Drug
Also called Phospho Soda
Osmotic preparation for colonoscopy
ColyteDrug
Also called Golytely
Lavage preparation for colonoscopy
Dual (OSPS & Colyte)Drug
Combined, two-day preparation utilizing both preparations
| Study group | Role | What they receive |
|---|---|---|
| 1 | SCI Receives: Drug: Fleets Oral Sodium Phosphate Solution (OSPS); Drug: Colyte; Drug: Dual (OSPS & Colyte) | |
| 2 | Able-bodied Receives: Drug: Fleets Oral Sodium Phosphate Solution (OSPS); Drug: Colyte; Drug: Dual (OSPS & Colyte) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function (GFR, creatinine clearance)
Measured: <30 days
Secondary outcomes (1)
Quality of bowel preparation (Ottawa Score)
Measured: <30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Mark A. Korsten, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856440
- Sponsor's protocol ID
- B4162C-1
- Other IDs
- 2380-06-031
- Status last verified
- Jul 2010
- First submitted
- 2 Mar 2009
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Routine Colonoscopy Preparations
- ClinicalTrials.gov ID
- NCT00856440
- Acronym / sponsor ID
- B4162C-1
- Conditions
- Spinal Cord Injury
- Keywords
- SCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Mar 2009 (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.
Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
Detailed description
Colonoscopy is a routine evaluation for screening of colorectal cancer in people over 50 and for those at increased genetic risk. Despite the large number of individuals requiring such screening, there has been little randomized, controlled research to determine the relative renal safety of oral colon preparation solutions that are used to evacuate the bowel in patients with "normal" kidney function, the best frequency of laxative dosing (e.g. 1 day vs. 2 day), and the quality of the colon cleansing that results from these different approaches. Reports of acute renal failure, secondary to nephrocalcinosis, following the commonly used oral phosphosoda preparation are increasingly recognized. It is our belief that this project will yield clinically relevant information that would have immediate clinical application for all persons receiving a colonoscopy. Since preparation for screening colonoscopy involves vigorous purging of stool from individuals without GI complaints, it also represents an opportunity to study the prevalence of clostridium difficile (C. diff) in this population. This may reveal important information regarding the epidemiology of this increasingly virulent and common enteric pathogen. A pilot screening program for asymptomatic C. diff, a common nosocomial pathogen, may reveal findings of clinical importance for preventing spread of this infection, and allow use of presumptive treatment during periods of increased risk.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Fleets Oral Sodium Phosphate Solution (OSPS), Drug: Colyte, Drug: Dual (OSPS & Colyte)SCI |
| 2 | – | Drug: Fleets Oral Sodium Phosphate Solution (OSPS), Drug: Colyte, Drug: Dual (OSPS & Colyte)Able-bodied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans, SCI and able-bodied
Key inclusion criteria (1 listed)
- 1. Patients already clinically indicated for colonoscopy examination
Key exclusion criteria (4 listed)
- Patients who are not a candidate for elective colonoscopy (i.e. those with recent myocardial infarction, terminal illness, etc.)
- Patients who have a contraindication for Colyte (i.e. those with colonic obstruction, etc.)
- Patients who have a contraindication for Fleet OSPS (i.e. those with poor renal function, class 2 or greater symptomatic heart failure, etc.)
- Pregnancy
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 |
|---|---|---|
| Fleets Oral Sodium Phosphate Solution (OSPS)Also: Phospho SodaOsmotic preparation for colonoscopy | Drug | 1, 2 |
| ColyteAlso: GolytelyLavage preparation for colonoscopy | Drug | 1, 2 |
| Dual (OSPS & Colyte)Combined, two-day preparation utilizing both preparations | Drug | 1, 2 |
Primary outcome
Renal Function (GFR, creatinine clearance)
Time frame: <30 days
1 secondary outcome
Quality of bowel preparation (Ottawa Score)
Time frame: <30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2010.
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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.
Mark A. Korsten, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Renal Function (GFR, creatinine clearance) (time frame: <30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2010.