Bowel Preparation QualityNCT03681444
Diet Selection Pre-Colonoscopy: Comparison Between Clear, Low-residue and Regular Diet
A study testing Regular diet, Clear fluid diet and Low residue diet in people with Bowel Preparation Quality, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Colonoscopy has been used for ages as an evaluating tool of the colonic mucosa for screening and early detection of colonic cancer. Several studies have reported that poor bowel preparation reduces detection of polyps that may have the potential to be cancerous. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bowel Preparation Quality
- What is being tested?
- Regular diet, Clear fluid diet and Low residue diet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Oct 2018to 30 May 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inpatients 18 to 75 years old
- undergoing colonoscopy for CRC screening
- with nonspecific gastrointestinal symptoms
Who cannot join
- outpatient status;
- serious medical conditions, such as severe cardiac, renal, liver, or metabolic disease;
- stroke or dementia;
- major psychiatric illness;
- known allergy to PEG;
- previous colon resection;
- incomplete colonoscopy examination (failure of cecal intubation);
- functional constipation defined by Rome III diagnostic criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diet Selection Pre-Colonoscopy: Any Difference Between Clear, Low-residue and Regular Diet on Bowel Prep Quality, Tolerance, Acceptance and Compliance
Colonoscopy has been used for ages as an evaluating tool of the colonic mucosa for screening and early detection of colonic cancer. Several studies have reported that poor bowel preparation reduces detection of polyps that may have the potential to be cancerous. Polyethylene glycol (PEG) has become the most commonly used agent for colon cleansing because it does not cause fluid exchange across the mucosal membrane and thereby limits fluid and electrolyte disturbances.
Only a few studies have evaluated the effects of different diet types on bowel preparation under controlled circumstances. Various studies were made to find the best pre-colonoscopy diet with no single clear study comparing all 3 dietary regimen together was carried out. So, evidence for the efficacy of a RD (regular diet) in bowel preparation is lacking, which led us to question whether it is reasonable to recommend a RD for 24 hours prior to colonoscopy as part of a PEG-based bowel prepa¬ration in healthy inpatients.
Read more
The investigators are proposing to carry out a randomized clinical trial at Makassed General Hospital and include patients from October 2018 till February 2019. The data of 90 stable adult patients will be obtained through patients' interviews.
In the trial, all adult inpatients (range, 18 to 80 years old) undergoing colonoscopy for colorectal cancer (CRC) screening in Makassed General Hospital with nonspecific gastrointestinal symptoms will be candidates for inclusion in the study. Patient receiving endoscopy will be asked to answer multiple questions on the day of procedure. Patients will be randomly allocated to one of 3 groups: Regular Diet (RD), Clear Fluid (CF) and Low-Residue Diet (LRD). The primary outcome will consist of the quality of bowel preparation and efficacy of colon cleansing.
Read the detailed description
The study will be conducted in Makassed General Hospital (MGH) including all admitted patients receiving colonoscopy for the different indications. All patients will receive low volume 2L alpha peg split preps given 8 hours apart at a rate of 1 cup q 30 minutes with addition of 1 L of pure water post each liter with the addition 10mg of bisacodyl the night before.
In the trial, all adult inpatients (range, 18 to 80 years old) undergoing colonoscopy for CRC screening In MGH or with nonspecific gastrointestinal symptoms will be candidates for inclusion in the study. Exclusion criteria will be as follows: outpatient status; serious medical condi¬tions, such as severe cardiac, renal, liver, or metabolic disease; stroke or dementia; major psychiatric illness; known allergy to polyethylene glycol (PEG); a previous colon resection; incomplete colonoscopy examination (failure of cecal intubation); or functional constipation defined by Rome III diagnostic criteria.
Patient information was collected before procedure which included age, gender, weight, height, body mass index (BMI), indications for colonoscopy, and history of previous operation and colonoscopy, as well as bowel frequency. Patients will complete a questionnaire before colonoscopy regarding their preparation experience (the start and end time for PEG solution ingestion; the amount of PEG solution ingested; any associated adverse effects, includ¬ing abdominal pain, nausea, vomiting, headache, dizziness, and others; and willingness to repeat the same preparation in the future) with the help of an endoscopy nurse who will be blinded to the dietary randomization.
Participants were categorized into subgroups with regard to compliance; good compliance was defined as less than 25% of the PEG solution remaining, and poor compliance was defined as 25% or more of the PEG solution remaining. The subjects were randomly assigned to either eat Regular diet (RD), clear fluid diet (CLD) or low-residue diet (LRD) explained to each randomized case by in-hospital dietitian. In all three groups the offered diet was given at breakfast and lunch with fluids only given at dinner.
- Conditions
- Bowel Preparation Quality
- Being tested
- Regular diet, Clear fluid diet, Low residue diet, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular dietOther
Patients will be provided with any type of food preferred at any time in any quantity
Clear fluid dietOther
Patients will be provided with
- Plain water
- Fruit juices without pulp, such as grape juice, filtered apple juice, and cranberry juice
- Soup broth (bouillon or consommé)
- Clear sodas, such as ginger ale and Sprite
- Gelatin (Jell-O)
- Tea or coffee with no cream or milk added
- Sports drinks that don't have color
Low residue dietOther
The Low Residue Diet is the same as the soft diet with the added limitation of milk to one pint. It provides foods that are easily digestible. It is often used as a transition diet from liquids to the general diet. Indigestible fiber is reduced by using tender cooked vegetables and ripe, canned or cooked fruits from which the tough skins and seeds have been removed. Tender meat or meat made tender in the cooking process is used, thus reducing the amount of connective tissue.
Adequacy: By following the recommended guidelines, the diet will be adequate according to the Recommended Daily Allowance.
Note: For patients with dentures this diet can be modified by the substitution of ground meat for whole meat and excluding all raw vegetables. Personal tolerances determine food choices; avoid foods that cause GI (gastrointestinal) distress prior to the admission even though that food may be on the "foods included" list.
ColonoscopyDiagnostic test
Colonoscopy will be performed under conscious sedation with intravenous midazolam and pethidine titrated as required
| Study group | Role | What they receive |
|---|---|---|
| Regular diet | Experimental | no dietary restriction Receives: Other: Regular diet; Diagnostic Test: Colonoscopy |
| Clear fluid diet | Placebo comparator | no solid material Receives: Other: Clear fluid diet; Diagnostic Test: Colonoscopy |
| Low residue diet | Experimental | easy digestible food Receives: Other: Low residue diet; Diagnostic Test: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel preparation quality: Ottawa bowel preparation scale
Bowel preparation quality will be assessed by Ottawa bowel preparation scale. The scale assesses three components of the large intestine: (1) the rectosigmoid colon, (2) the mid colon and (3) the right colon.
A maximum score of 4 is used for each section of the large intestine. A score of 0 is given if the bowel preparation is excellent, a score of 1 is given if the bowel preparation is good, a score of 2 is given if the bowel preparation is fair, a score of 3 is given if the bowel preparation is poor, a score of 4 is given if the bowel preparation is inadequate. The total score is calculated by adding up all 3 scores. The scale has a range from 0 (perfect) to 14 (a completely unprepared colon).
Measured: within 15 minutes after procedure
Secondary outcomes (1)
best convenient dietary regimen
Find out the best convenient dietary regimen for pre-colonoscopy preparation evaluated through a questionnaire to assess patient's experience with the bowel preparation model. The questionnaire asks about compliance (good or poor), acceptance (yes or no) and willingness to repeat preparation (yes or no)
Measured: before procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Oct 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation QualityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ghassan Hemadeh, Makassed General Hospital
- Investigators
- Ghassan Hemadeh, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681444
- Sponsor's protocol ID
- 10218
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Selection Pre-Colonoscopy: Any Difference Between Clear, Low-residue and Regular Diet on Bowel Prep Quality, Tolerance, Acceptance and Compliance
- ClinicalTrials.gov ID
- NCT03681444
- Acronym / sponsor ID
- 10218
- Conditions
- Bowel Preparation Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 24 Sep 2018 (actual)
- 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.
Colonoscopy has been used for ages as an evaluating tool of the colonic mucosa for screening and early detection of colonic cancer. Several studies have reported that poor bowel preparation reduces detection of polyps that may have the potential to be cancerous. Polyethylene glycol (PEG) has become the most commonly used agent for colon cleansing because it does not cause fluid exchange across the mucosal membrane and thereby limits fluid and electrolyte disturbances.
Only a few studies have evaluated the effects of different diet types on bowel preparation under controlled circumstances. Various studies were made to find the best pre-colonoscopy diet with no single clear study comparing all 3 dietary regimen together was carried out. So, evidence for the efficacy of a RD (regular diet) in bowel preparation is lacking, which led us to question whether it is reasonable to recommend a RD for 24 hours prior to colonoscopy as part of a PEG-based bowel prepa¬ration in healthy inpatients.
The investigators are proposing to carry out a randomized clinical trial at Makassed General Hospital and include patients from October 2018 till February 2019. The data of 90 stable adult patients will be obtained through patients' interviews.
In the trial, all adult inpatients (range, 18 to 80 years old) undergoing colonoscopy for colorectal cancer (CRC) screening in Makassed General Hospital with nonspecific gastrointestinal symptoms will be candidates for inclusion in the study. Patient receiving endoscopy will be asked to answer multiple questions on the day of procedure. Patients will be randomly allocated to one of 3 groups: Regular Diet (RD), Clear Fluid (CF) and Low-Residue Diet (LRD). The primary outcome will consist of the quality of bowel preparation and efficacy of colon cleansing.
Detailed description
The study will be conducted in Makassed General Hospital (MGH) including all admitted patients receiving colonoscopy for the different indications. All patients will receive low volume 2L alpha peg split preps given 8 hours apart at a rate of 1 cup q 30 minutes with addition of 1 L of pure water post each liter with the addition 10mg of bisacodyl the night before.
In the trial, all adult inpatients (range, 18 to 80 years old) undergoing colonoscopy for CRC screening In MGH or with nonspecific gastrointestinal symptoms will be candidates for inclusion in the study. Exclusion criteria will be as follows: outpatient status; serious medical condi¬tions, such as severe cardiac, renal, liver, or metabolic disease; stroke or dementia; major psychiatric illness; known allergy to polyethylene glycol (PEG); a previous colon resection; incomplete colonoscopy examination (failure of cecal intubation); or functional constipation defined by Rome III diagnostic criteria.
Patient information was collected before procedure which included age, gender, weight, height, body mass index (BMI), indications for colonoscopy, and history of previous operation and colonoscopy, as well as bowel frequency. Patients will complete a questionnaire before colonoscopy regarding their preparation experience (the start and end time for PEG solution ingestion; the amount of PEG solution ingested; any associated adverse effects, includ¬ing abdominal pain, nausea, vomiting, headache, dizziness, and others; and willingness to repeat the same preparation in the future) with the help of an endoscopy nurse who will be blinded to the dietary randomization.
Participants were categorized into subgroups with regard to compliance; good compliance was defined as less than 25% of the PEG solution remaining, and poor compliance was defined as 25% or more of the PEG solution remaining. The subjects were randomly assigned to either eat Regular diet (RD), clear fluid diet (CLD) or low-residue diet (LRD) explained to each randomized case by in-hospital dietitian. In all three groups the offered diet was given at breakfast and lunch with fluids only given at dinner.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular diet | Experimental | Other: Regular diet, Diagnostic Test: Colonoscopyno dietary restriction |
| Clear fluid diet | Placebo comparator | Other: Clear fluid diet, Diagnostic Test: Colonoscopyno solid material |
| Low residue diet | Experimental | Other: Low residue diet, Diagnostic Test: Colonoscopyeasy digestible food |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- inpatients 18 to 75 years old
- undergoing colonoscopy for CRC screening
- with nonspecific gastrointestinal symptoms
Key exclusion criteria (8 listed)
- outpatient status;
- serious medical conditions, such as severe cardiac, renal, liver, or metabolic disease;
- stroke or dementia;
- major psychiatric illness;
- known allergy to PEG;
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 |
|---|---|---|
| Regular dietPatients will be provided with any type of food preferred at any time in any quantity | Other | Regular diet |
| Clear fluid dietPatients will be provided with * Plain water * Fruit juices without pulp, such as grape juice, filtered apple juice, and cranberry juice * Soup broth (bouillon or consommé) * Clear sodas, such as ginger ale and Sprite * Gelatin (Jell-O) * Tea or coffee with no cream or milk added * Sports drinks that don't have color | Other | Clear fluid diet |
| Low residue dietThe Low Residue Diet is the same as the soft diet with the added limitation of milk to one pint. It provides foods that are easily digestible. It is often used as a transition diet from liquids to the general diet. Indigestible fiber is reduced by using tender cooked vegetables and ripe, canned or cooked fruits from which the tough skins and seeds have been removed. Tender meat or meat made tender in the cooking process is used, thus reducing the amount of connective tissue. Adequacy: By following the recommended guidelines, the diet will be adequate according to the Recommended Daily Allowance. Note: For patients with dentures this diet can be modified by the substitution of ground meat for whole meat and excluding all raw vegetables. Personal tolerances determine food choices; avoid foods that cause GI (gastrointestinal) distress prior to the admission even though that food may be on the "foods included" list. | Other | Low residue diet |
| ColonoscopyColonoscopy will be performed under conscious sedation with intravenous midazolam and pethidine titrated as required | Diagnostic test | Clear fluid diet, Low residue diet, Regular diet |
Primary outcome
bowel preparation quality: Ottawa bowel preparation scale
Time frame: within 15 minutes after procedure
Bowel preparation quality will be assessed by Ottawa bowel preparation scale. The scale assesses three components of the large intestine: (1) the rectosigmoid colon, (2) the mid colon and (3) the right colon. A maximum score of 4 is used for each section of the large intestine. A score of 0 is given if the bowel preparation is excellent, a score of 1 is given if the bowel preparation is good, a score of 2 is given if the bowel preparation is fair, a score of 3 is given if the bowel preparation is poor, a score of 4 is given if the bowel preparation is inadequate. The total score is calculated by adding up all 3 scores. The scale has a range from 0 (perfect) to 14 (a completely unprepared colon).
1 secondary outcome
best convenient dietary regimen
Time frame: before procedure
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 27 Sep 2019.
Related trials for Bowel Preparation Quality
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
Not yet recruiting
Right Colon Enema to Improve Bowel Preparation Quality During Colonoscopy
Colonic Polyps, Colorectal Neoplasms
Recruiting
A Multi-Center Randomized Controlled Trial on the Impact of Disease Subtype-Based Active Video Education on Bowel Preparation Quality in Patients With Inflammatory Bowel Disease
Inflammatory Bowel Diseases
Not yet recruitingObservational study
Correlation Between Artificial Intelligence-Based Fecal Coverage Area-Quantified Bowel Preparation Quality Score (FQ-BBPS) and Adenoma Detection Rate
Colorectal Adenoma
Active, not recruiting
The Efficacy of AI-Driven Feces Identification for Bowel Preparation Prior to Colonoscopy
AI App Improves Bowel Preparation Quality for Colonoscopy
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.
Ghassan Hemadeh, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular diet, Clear fluid diet and Low residue diet in people with Bowel Preparation Quality, run by Makassed General Hospital at 1 site in Lebanon.
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 3 inclusion and 8 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 27 Sep 2019. 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 Lebanon. 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. Some participants in this study may receive a placebo. 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?
bowel preparation quality: Ottawa bowel preparation scale (time frame: within 15 minutes after procedure). 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 27 Sep 2019.