Colorectal CancerNCT02621658
Clear Liquid vs Liberalized Diet in Preparation for Colonoscopy
A study testing Clear Liquid Diet and Full Liquid Diet in people with Colorectal Cancer, run by San Antonio Military Medical Center.
Trial summary
Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States. The death rate from this disease, however, has been decreasing over the last 20 years. Early detection and removal of pre-malignant polyps is considered to be at the core of this change. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Clear Liquid Diet and Full Liquid Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic patients 50 years old or older, undergoing screening colonoscopy and willing to participate in the study will be included, after obtaining informed/written consent.
Who cannot join
- Symptomatic patients, patients with indications for therapeutic colonoscopy, like for example, rectal bleeding or with a prior diagnosis requiring evaluation with colonoscopy(Prior diagnosis of colon polyps, Iron-deficiency Anemia, Inflammatory Bowel Disease, Colorectal Cancer, Chronic diarrhea, Abnormal Imaging) will be excluded from participation. Please note that patients with Iron-deficiency Anemia will not be excluded from the study, based solely on this diagnosis, if they have an indication, otherwise, for Screening Colonoscopy.
Trial locations and contacts
No sites are listed yet.
About this study
Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States. The death rate from this disease, however, has been decreasing over the last 20 years. Early detection and removal of pre-malignant polyps is considered to be at the core of this change. At the same time, polyp detection is highly dependent on an adequate bowel preparation. Froehlich, et al., found that poor bowel preparation is associated with longer colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2).
Although a Clear Liquid Diet is usually the prescribed diet in most bowel preparation regimes, several studies have shown similar results with less restrictive diets.
Read more
Based on the hypothesis that a Full Liquid Diet(FLD) is not inferior to a Clear Liquid Diet(CLD), investigators plan to conduct a prospective, randomized trial, in order to compare these dietary interventions. The investigators and endoscopists will be blinded to patient's diet group.
Researchers aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD). Investigators will compare the performance of these dietary interventions regarding adenoma detection rates(ADR), time to cecal intubation(TCI), and colonoscope withdrawal time. In addition, the investigators want to assess whether patient's Compliance and Satisfaction is similar or superior in the experimental group vs the control group.
Read the detailed description
The purpose of this study is to investigate if a Full Liquid Diet is not inferior to a Clear Liquid Diet in preparation for Screening Colonoscopy. Based on the data presented above, the investigators hypothesize that a Full Liquid Diet will be better tolerated by participants and will not adversely affect colonoscopy outcomes in terms of bowel cleansing(BC), adenoma detection rate(ADR), time to cecal intubation(TCI).
The results of this study may help guide dietary interventions in preparation for Colonoscopy in the Department of Defense(DOD) Military Treatment Facilities.
The relationship between adequate colon cleansing and adenoma detection rate(ADR) has been already established. Almost 25% of patients, however, have a poor bowel preparation at the time of Colonoscopy(1). After reviewing 5832 colonoscopies, Froehlich, et al., found that poor bowel preparation is associated with longer colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2).
Among other causes, bowel cleansing is affected by purgative selection and timing of administration, compliance with recommended pre-procedural diet and compliance with purgative administration. Recently, it has been found that the classically recommended clear liquid diet(CLD) is not indispensable for adequate bowel prep. Stolpman, et. al, found that a low-residue diet is non-inferior to clear liquid diet(CLD), in a group of 201 patients(3). Similarly, Melicharkova, et al, found that the bowel cleansing efficacy of a low-residue breakfast, the day before colonoscopy, was comparable with a clear liquid diet(CLD) in a sample of 213 patients administered a low volume purgative in preparation for colonoscopy(4). They also found a statistically significant difference in the level of patient's acceptance of the low-residue diet.
A group from South Korea, led by Dr. Jung Yoon, found similar rates of bowel cleansing in patient undergoing afternoon colonoscopy, when offered Regular Diet(5). A study, in a small study population, presented as an abstract at the American College of Gastroenterology Conference in 2011, reported comparable bowel cleansing, polyp detection rate, and colonoscopy times in patients allowed a full liquid diet before the procedure(6). Taken together, these studies show that a clear liquid diet may not be necessary in order to obtain a good bowel cleanse in preparation for colonoscopies performed in the outpatient setting.
A clear liquid diet is still the recommended diet, however, before this procedure.
Given the diverse population served at Military Treatments Facilities across the United States, and abroad, the investigators aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD). In addition, the investigators will compare the performance of these diets regarding adenoma detection rates(ADR), time to cecal intubation(TCI), withdrawal time, and patient satisfaction.
This study will be conducted as a prospective, randomized trial. The investigators and endoscopists will be blinded to patient's diet group.
Patients 50 y/o, or older, undergoing screening colonoscopy will be offered participation in the study.
If written, informed consent is obtained, participants will be randomized to (A)Control Group or (B) Study Group(in a 1:1 fashion). Study randomization will be performed by using serially numbered envelopes containing instructions for CLD or FLD. The control group will be allowed to have a Clear Liquid Diet the day before colonoscopy and the Study Group will be allowed to have a Full Liquid Diet the day before colonoscopy. These envelopes will be prepared in duplicates. One envelope will be provided to the participant and one envelope will be maintained, sealed, by the study group.
Study participants will complete a Bowel Preparation consisting of bisacodyl 10mg per mouth x1(at noon, the day before colonoscopy) and 4L Polyethylene Glycol solution(split dose). Subjects will drink 2 L of Polyethylene Glycol at 17:00 the day before colonoscopy and the other 2 L at 04:00, the morning prior to colonoscopy.
They will follow one of the diets described above, based on randomization, and will present to the BAMC Gastroenterology Clinic for Colonoscopy. Before the procedure, subjects will be administered a questionnaire in order to assess their compliance, tolerability and satisfaction with the diet. Research team and Endoscopists will also be blinded to these questionnaires until the data collection process has finished.
Colonoscopy will be performed in the usual fashion. Endoscopists will assess the level of subject's colon cleansing by means of the Boston Bowel Preparation Scale(7). Time to Cecal Intubation and Colonoscope Withdrawal Time will be documented, as is currently done at the BAMC Gastroenterology Clinic.
Adenoma Detection Rates(number of screened patients with at least one adenoma divided by total number of patients screened with colonoscopy) will be calculated.
Investigators will compare Bowel Prep Quality/Colon Cleansing, Time to Cecal Intubation, ADR, and Patient's Compliance and Satisfaction with the bowel preparation between the two groups.
Primarily, the investigators want to assess whether Bowel Prep Quality/Colon Cleansing and ADR for the experimental group is non-inferior to Bowel Prep Quality and ADR for the control group. In addition, the investigators will asses whether participant's Compliance and Satisfaction is similar or superior in the experimental group vs the control group.
- Conditions
- Colorectal Cancer
- Being tested
- Clear Liquid Diet, Full Liquid Diet
- Keywords
- Colorectal Cancer, Colonoscopy, Adenoma Detection Rate, Bowel Preparation, Time to Cecal Intubation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Liquid DietOther
Patients will be allowed to consume clear soft drinks like ginger ales, Sprite®, 7-Up®, Gatorade®, Kool Aid®. They can also have strained fruit juices like apple, white grape juice and lemonade, and water, tea and coffee without milk or non-dairy creamer. Patient in this arm will also be allowed to have low-sodium chicken or beef broth , in addition to non-red hard candies, Jell-O®, and popsicles.
Full Liquid DietOther
Patients will be allowed to consume a Full Liquid Diet, including nutritional supplements(Ensure®, Boost®, Glucerna®), strained cereals(like cream of wheat or strained oatmeal) and vegetables, purred fruit without seeds or pulp, milk, plain ice cream or yogurt, sherbet, coffee with cream, and tea.
| Study group | Role | What they receive |
|---|---|---|
| Clear Liquid Diet | Active comparator | Clear Liquid Diet the day before colonoscopy. Receives: Other: Clear Liquid Diet |
| Full Liquid Diet | Experimental | Full Liquid Diet the day before colonoscopy. Receives: Other: Full Liquid Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bowel Preparation
This will be assessed using the Boston Bowel Preparation Scale
Measured: At the time of Colonoscopy
Time to Cecal Intubation
Measured: During Colonoscopy
Colonoscope Withdrawal time
Time elapsed since the endoscopist starts withdrawing the colonoscope, after reaching the cecum, until the completion of the test.
Measured: During Colonoscopy
Adenoma Detection Rate
Number of patients with at least one adenoma, divided by total number of patients aged 50 years or older screened with colonoscopy
Measured: During Colonoscopy
Secondary outcomes (2)
Patient compliance
Will be measured using a questionnaire
Measured: Before Colonoscopy
Patient satisfaction
Will be measured using a questionnaire
Measured: Before Colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Antonio Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Luis X. Velez-Colon, MD, San Antonio Military Medical Center
- Investigators
- Luis X Velez-Colon, MD, Principal investigator, San Antonio Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621658
- Sponsor's protocol ID
- Bowel Prep Protocol
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.
PubMed 12838225Stolpman DR, Solem CA, Eastlick D, Adlis S, Shaw MJ. A randomized controlled trial comparing a low-residue diet versus clear liquids for colonoscopy preparation: impact on tolerance, procedure time, and adenoma detection rate. J Clin Gastroenterol. 2014 Nov-Dec;48(10):851-5. doi: 10.1097/MCG.0000000000000167.
PubMed 25296243Jung YS, Seok HS, Park DI, Song CS, Kim SE, Lee SH, Eun CS, Han DS, Kim YS, Lee CK. A clear liquid diet is not mandatory for polyethylene glycol-based bowel preparation for afternoon colonoscopy in healthy outpatients. Gut Liver. 2013 Nov;7(6):681-7. doi: 10.5009/gnl.2013.7.6.681. Epub 2013 Aug 14.
PubMed 24312709Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
PubMed 15758907Melicharkova A, Flemming J, Vanner S, Hookey L. A low-residue breakfast improves patient tolerance without impacting quality of low-volume colon cleansing prior to colonoscopy: a randomized trial. Am J Gastroenterol. 2013 Oct;108(10):1551-5. doi: 10.1038/ajg.2013.21.
PubMed 24091500Full Liquid Diet vs Clear Liquid Diet for Colonoscopy Preparation: Preliminary Results. Gutkin E, et. al. ACG2011; Abstract P412
Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
PubMed 20883845Agresti A, Coull BA, Approximate is better than "exact" for interval estimation of binomial proportions, The American Statistician 52:119-126, 1998.
Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996 Jul 6;313(7048):36-9. doi: 10.1136/bmj.313.7048.36.
PubMed 8664772
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clear Liquid vs Liberalized Diet in Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT02621658
- Acronym / sponsor ID
- Bowel Prep Protocol
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Colonoscopy, Adenoma Detection Rate, Bowel Preparation, Time to Cecal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- San Antonio Military Medical CenterUS federal agency
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Dec 2015 (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.
Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States. The death rate from this disease, however, has been decreasing over the last 20 years. Early detection and removal of pre-malignant polyps is considered to be at the core of this change. At the same time, polyp detection is highly dependent on an adequate bowel preparation. Froehlich, et al., found that poor bowel preparation is associated with longer colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2).
Although a Clear Liquid Diet is usually the prescribed diet in most bowel preparation regimes, several studies have shown similar results with less restrictive diets.
Based on the hypothesis that a Full Liquid Diet(FLD) is not inferior to a Clear Liquid Diet(CLD), investigators plan to conduct a prospective, randomized trial, in order to compare these dietary interventions. The investigators and endoscopists will be blinded to patient's diet group.
Researchers aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD). Investigators will compare the performance of these dietary interventions regarding adenoma detection rates(ADR), time to cecal intubation(TCI), and colonoscope withdrawal time. In addition, the investigators want to assess whether patient's Compliance and Satisfaction is similar or superior in the experimental group vs the control group.
Detailed description
The purpose of this study is to investigate if a Full Liquid Diet is not inferior to a Clear Liquid Diet in preparation for Screening Colonoscopy. Based on the data presented above, the investigators hypothesize that a Full Liquid Diet will be better tolerated by participants and will not adversely affect colonoscopy outcomes in terms of bowel cleansing(BC), adenoma detection rate(ADR), time to cecal intubation(TCI).
The results of this study may help guide dietary interventions in preparation for Colonoscopy in the Department of Defense(DOD) Military Treatment Facilities.
The relationship between adequate colon cleansing and adenoma detection rate(ADR) has been already established. Almost 25% of patients, however, have a poor bowel preparation at the time of Colonoscopy(1). After reviewing 5832 colonoscopies, Froehlich, et al., found that poor bowel preparation is associated with longer colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2).
Among other causes, bowel cleansing is affected by purgative selection and timing of administration, compliance with recommended pre-procedural diet and compliance with purgative administration. Recently, it has been found that the classically recommended clear liquid diet(CLD) is not indispensable for adequate bowel prep. Stolpman, et. al, found that a low-residue diet is non-inferior to clear liquid diet(CLD), in a group of 201 patients(3). Similarly, Melicharkova, et al, found that the bowel cleansing efficacy of a low-residue breakfast, the day before colonoscopy, was comparable with a clear liquid diet(CLD) in a sample of 213 patients administered a low volume purgative in preparation for colonoscopy(4). They also found a statistically significant difference in the level of patient's acceptance of the low-residue diet.
A group from South Korea, led by Dr. Jung Yoon, found similar rates of bowel cleansing in patient undergoing afternoon colonoscopy, when offered Regular Diet(5). A study, in a small study population, presented as an abstract at the American College of Gastroenterology Conference in 2011, reported comparable bowel cleansing, polyp detection rate, and colonoscopy times in patients allowed a full liquid diet before the procedure(6). Taken together, these studies show that a clear liquid diet may not be necessary in order to obtain a good bowel cleanse in preparation for colonoscopies performed in the outpatient setting.
A clear liquid diet is still the recommended diet, however, before this procedure.
Given the diverse population served at Military Treatments Facilities across the United States, and abroad, the investigators aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD). In addition, the investigators will compare the performance of these diets regarding adenoma detection rates(ADR), time to cecal intubation(TCI), withdrawal time, and patient satisfaction.
This study will be conducted as a prospective, randomized trial. The investigators and endoscopists will be blinded to patient's diet group.
Patients 50 y/o, or older, undergoing screening colonoscopy will be offered participation in the study.
If written, informed consent is obtained, participants will be randomized to (A)Control Group or (B) Study Group(in a 1:1 fashion). Study randomization will be performed by using serially numbered envelopes containing instructions for CLD or FLD. The control group will be allowed to have a Clear Liquid Diet the day before colonoscopy and the Study Group will be allowed to have a Full Liquid Diet the day before colonoscopy. These envelopes will be prepared in duplicates. One envelope will be provided to the participant and one envelope will be maintained, sealed, by the study group.
Study participants will complete a Bowel Preparation consisting of bisacodyl 10mg per mouth x1(at noon, the day before colonoscopy) and 4L Polyethylene Glycol solution(split dose). Subjects will drink 2 L of Polyethylene Glycol at 17:00 the day before colonoscopy and the other 2 L at 04:00, the morning prior to colonoscopy.
They will follow one of the diets described above, based on randomization, and will present to the BAMC Gastroenterology Clinic for Colonoscopy. Before the procedure, subjects will be administered a questionnaire in order to assess their compliance, tolerability and satisfaction with the diet. Research team and Endoscopists will also be blinded to these questionnaires until the data collection process has finished.
Colonoscopy will be performed in the usual fashion. Endoscopists will assess the level of subject's colon cleansing by means of the Boston Bowel Preparation Scale(7). Time to Cecal Intubation and Colonoscope Withdrawal Time will be documented, as is currently done at the BAMC Gastroenterology Clinic.
Adenoma Detection Rates(number of screened patients with at least one adenoma divided by total number of patients screened with colonoscopy) will be calculated.
Investigators will compare Bowel Prep Quality/Colon Cleansing, Time to Cecal Intubation, ADR, and Patient's Compliance and Satisfaction with the bowel preparation between the two groups.
Primarily, the investigators want to assess whether Bowel Prep Quality/Colon Cleansing and ADR for the experimental group is non-inferior to Bowel Prep Quality and ADR for the control group. In addition, the investigators will asses whether participant's Compliance and Satisfaction is similar or superior in the experimental group vs the control group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear Liquid Diet | Active comparator | Other: Clear Liquid DietClear Liquid Diet the day before colonoscopy. |
| Full Liquid Diet | Experimental | Other: Full Liquid DietFull Liquid Diet the day before colonoscopy. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asymptomatic patients 50 years old or older, undergoing screening colonoscopy and willing to participate in the study will be included, after obtaining informed/written consent.
Key exclusion criteria (1 listed)
- Symptomatic patients, patients with indications for therapeutic colonoscopy, like for example, rectal bleeding or with a prior diagnosis requiring evaluation with colonoscopy(Prior diagnosis of colon polyps, Iron-deficiency Anemia, Inflammatory Bowel Disease, Colorectal Cancer, Chronic diarrhea, Abnormal Imaging) will be excluded from participation. Please note that patients with Iron-deficiency Anemia will not be excluded from the study, based solely on this diagnosis, if they have an indication, otherwise, for Screening Colonoscopy.
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 |
|---|---|---|
| Clear Liquid DietPatients will be allowed to consume clear soft drinks like ginger ales, Sprite®, 7-Up®, Gatorade®, Kool Aid®. They can also have strained fruit juices like apple, white grape juice and lemonade, and water, tea and coffee without milk or non-dairy creamer. Patient in this arm will also be allowed to have low-sodium chicken or beef broth , in addition to non-red hard candies, Jell-O®, and popsicles. | Other | Clear Liquid Diet |
| Full Liquid DietPatients will be allowed to consume a Full Liquid Diet, including nutritional supplements(Ensure®, Boost®, Glucerna®), strained cereals(like cream of wheat or strained oatmeal) and vegetables, purred fruit without seeds or pulp, milk, plain ice cream or yogurt, sherbet, coffee with cream, and tea. | Other | Full Liquid Diet |
Primary outcome
Quality of Bowel Preparation
Time frame: At the time of Colonoscopy
This will be assessed using the Boston Bowel Preparation Scale
Time to Cecal Intubation
Time frame: During Colonoscopy
Colonoscope Withdrawal time
Time frame: During Colonoscopy
Time elapsed since the endoscopist starts withdrawing the colonoscope, after reaching the cecum, until the completion of the test.
Adenoma Detection Rate
Time frame: During Colonoscopy
Number of patients with at least one adenoma, divided by total number of patients aged 50 years or older screened with colonoscopy
2 secondary outcomes
Patient compliance
Time frame: Before Colonoscopy
Patient satisfaction
Time frame: Before Colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 12838225Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.
- Background: PubMed 25296243Stolpman DR, Solem CA, Eastlick D, Adlis S, Shaw MJ. A randomized controlled trial comparing a low-residue diet versus clear liquids for colonoscopy preparation: impact on tolerance, procedure time, and adenoma detection rate. J Clin Gastroenterol. 2014 Nov-Dec;48(10):851-5. doi: 10.1097/MCG.0000000000000167.
- Background: PubMed 24312709Jung YS, Seok HS, Park DI, Song CS, Kim SE, Lee SH, Eun CS, Han DS, Kim YS, Lee CK. A clear liquid diet is not mandatory for polyethylene glycol-based bowel preparation for afternoon colonoscopy in healthy outpatients. Gut Liver. 2013 Nov;7(6):681-7. doi: 10.5009/gnl.2013.7.6.681. Epub 2013 Aug 14.
- Background: PubMed 15758907Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
- Background: PubMed 24091500Melicharkova A, Flemming J, Vanner S, Hookey L. A low-residue breakfast improves patient tolerance without impacting quality of low-volume colon cleansing prior to colonoscopy: a randomized trial. Am J Gastroenterol. 2013 Oct;108(10):1551-5. doi: 10.1038/ajg.2013.21.
- BackgroundFull Liquid Diet vs Clear Liquid Diet for Colonoscopy Preparation: Preliminary Results. Gutkin E, et. al. ACG2011; Abstract P412
- Background: PubMed 20883845Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
- BackgroundAgresti A, Coull BA, Approximate is better than "exact" for interval estimation of binomial proportions, The American Statistician 52:119-126, 1998.
- Background: PubMed 8664772Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996 Jul 6;313(7048):36-9. doi: 10.1136/bmj.313.7048.36.
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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.
Luis X Velez-Colon, MD principal investigator
San Antonio Military Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Clear Liquid Diet and Full Liquid Diet in people with Colorectal Cancer, run by San Antonio Military Medical Center.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis X. Velez-Colon, MD (210-916-1759, luis.x.velezcolon.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Bowel Preparation (time frame: At the time of Colonoscopy). The study lists 4 primary outcomes in all. 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 NCT02621658, which also lists 9 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 3 Dec 2015.