Bowel PreparationPhase 4NCT02761317
Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery
A Phase 4 study testing standard preparation (2L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS) and high-volume preparation (4L PEG-ELS) in people with Bowel Preparation, run by Shandong University at 1 site in China.
Trial summary
The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with previous colorectal resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- standard preparation (2L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS) and high-volume preparation (4L PEG-ELS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Nov 2016
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults (18< age<75years) referred for surveillance colonoscopy with a history of colorectal resection for Colorectal cancer (CRC).
Who cannot join
- severe comorbidities (e.g. congestive heart failure and severe kidney disease)
- abdominal and pelvic surgery other than colorectal resection for the cause of CRC.
- severe colonic stricture or obstructing tumour
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction
Show all 16Show fewer
- known or suspected bowel obstruction or perforation
- severe chronic renal failure (creatinine clearance<30 ml/min
- severe congestive heart failure (New York Heart Association class III or IV)
- uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- inflammatory bowel disease or megacolon
- dehydration
- disturbance of electrolytes
- pregnancy or lactation
- haemodynamically unstable
- unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PhD. MD., 86-531-82169236 ext. 82169508, qiluliyanqing@gmail.com
Yanqing li, PhD. MD.
About this study
Official title: Optimal Bowel Preparation Regimen for Patients With With a History of Colorectal Resection Before Colonoscopy
The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with previous colorectal resection.
Read the detailed description
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost. A history of colorectal resection represents an independent predictor for inadequate colon cleansing,hence strategies to improve bowel preparation may be a demanding goal in this subset of patients.
The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L polyethylene glycol electrolyte solution) and high-volume preparation (4L polyethylene glycol electrolyte solution, 4L PEG-ELS) in patients with previous colorectal resection. Then the investigators can select the optimized regimen for patients with colorectal surgery.
- Conditions
- Bowel Preparation
- Being tested
- standard preparation (2L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS), high-volume preparation (4L PEG-ELS)
- Keywords
- bowel preparation, bisacodyl, polyethyleneglycol, colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard preparation (2L PEG-ELS)Drug
Subjects who are randomized into group A will receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.
low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)Drug
Subjects who are randomized into group B will receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure.
high-volume preparation (4L PEG-ELS)Drug
Subjects who are randomized into group C will receive 2L PEG at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure.(4L PEG)
| Study group | Role | What they receive |
|---|---|---|
| GroupA：standard preparation | Active comparator | Subjects who are randomized into group A receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure. Receives: Drug: standard preparation (2L PEG-ELS) |
| Group B:low-volume preparation | Experimental | Subjects who are randomized into group B receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure. ( 2L PEG-ELS and 10mg bisacodyl ) Receives: Drug: low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS) |
| Group C：high-volume preparation | Experimental | Subjects who are randomized into group C will receive 2L PEG-ELS at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure. (4 L PEG-ELS) Receives: Drug: high-volume preparation (4L PEG-ELS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of scores rating by Aronchick Preparation Scale among 3 groups.
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.
Measured: 6 months
Secondary outcomes (5)
Rate of compliance with instructions among 3 groups
Compliance was scored on a 3-grade scale based on the intake of bowel solution: 0 = optimal (intake of 100% of the solution); 1 = good (intake of ≥75% of the solution); 2 = poor (intake of <75% of the solution).
Measured: 6 months
Willingness to repeat bowel preparation among 3 groups.
the willingness to repeat the same bowel preparation,a patient's subjective evaluation of the bowel preparation was recorded by a questionnaire
Measured: 6 months
Polyp detection rate among 3 groups.
Polyp detection rate was defined as the proportion of patients with at least one polyp.
Measured: 6 months
Withdrawal time among 3 groups.
Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps.
Measured: 6 months
Caecal intubation rate among 3 groups.
Caecal intubation rate is defined the proportion of patients with caecal intubation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- li yanqing, PhD,MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761317
- Sponsor's protocol ID
- 2016SDU-QILU-03
- Status last verified
- May 2016
- First submitted
- 28 Apr 2016
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Bowel Preparation Regimen for Patients With With a History of Colorectal Resection Before Colonoscopy
- ClinicalTrials.gov ID
- NCT02761317
- Acronym / sponsor ID
- 2016SDU-QILU-03
- Conditions
- Bowel Preparation
- Keywords
- bowel preparation, bisacodyl, polyethyleneglycol, colorectal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 4 May 2016 (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 study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with previous colorectal resection.
Detailed description
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost. A history of colorectal resection represents an independent predictor for inadequate colon cleansing,hence strategies to improve bowel preparation may be a demanding goal in this subset of patients.
The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L polyethylene glycol electrolyte solution) and high-volume preparation (4L polyethylene glycol electrolyte solution, 4L PEG-ELS) in patients with previous colorectal resection. Then the investigators can select the optimized regimen for patients with colorectal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GroupA：standard preparation | Active comparator | Drug: standard preparation (2L PEG-ELS)Subjects who are randomized into group A receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure. |
| Group B:low-volume preparation | Experimental | Drug: low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)Subjects who are randomized into group B receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure. ( 2L PEG-ELS and 10mg bisacodyl ) |
| Group C：high-volume preparation | Experimental | Drug: high-volume preparation (4L PEG-ELS)Subjects who are randomized into group C will receive 2L PEG-ELS at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure. (4 L PEG-ELS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults (18< age<75years) referred for surveillance colonoscopy with a history of colorectal resection for Colorectal cancer (CRC).
Key exclusion criteria (16 listed)
- severe comorbidities (e.g. congestive heart failure and severe kidney disease)
- abdominal and pelvic surgery other than colorectal resection for the cause of CRC.
- severe colonic stricture or obstructing tumour
- dysphagia
- compromised swallowing reflex or mental status
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 |
|---|---|---|
| standard preparation (2L PEG-ELS)Subjects who are randomized into group A will receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure. | Drug | GroupA：standard preparation |
| low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)Subjects who are randomized into group B will receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure. | Drug | Group B:low-volume preparation |
| high-volume preparation (4L PEG-ELS)Subjects who are randomized into group C will receive 2L PEG at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure.(4L PEG) | Drug | Group C：high-volume preparation |
Primary outcome
Difference of scores rating by Aronchick Preparation Scale among 3 groups.
Time frame: 6 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.
5 secondary outcomes
Rate of compliance with instructions among 3 groups
Time frame: 6 months
Willingness to repeat bowel preparation among 3 groups.
Time frame: 6 months
Polyp detection rate among 3 groups.
Time frame: 6 months
Withdrawal time among 3 groups.
Time frame: 6 months
Caecal intubation rate among 3 groups.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
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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.
li yanqing, PhD,MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing standard preparation (2L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS) and high-volume preparation (4L PEG-ELS) in people with Bowel Preparation, run by Shandong University at 1 site in China.
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 16 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 2 Jun 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact li yanqing, PhD,MD (86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of scores rating by Aronchick Preparation Scale among 3 groups. (time frame: 6 months). 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 2 Jun 2016.