Bowel PreparationPhase 4NCT02396017
Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy
A Phase 4 study testing Capsule endoscopy and Polyethylene Glycol in people with Bowel Preparation, run by Centro Hospitalar Lisboa Ocidental at 1 site in Portugal.
Trial summary
To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Capsule endoscopy and Polyethylene Glycol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2015to May 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult patients referred to our institution for CE during the study period
Who cannot join
- inpatients, bedridden, patients with clinical evidence of active bleeding, past history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel perforation (suspected or confirmed), use of oral iron replacement therapy, severe cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any components of the preparation, patients that didn't complete the preparation protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined by the visualization of the mucosa from the duodenal bulb to the cecum), patients enrolled in other clinical studies and patients who didn't signed informed consent.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Gastroenterology Department, Hospital Egas Moniz
Lisbon, Lisbon District, 1349-019 Lisboa
Pedro Magalhães-Costa, MD, 00351963532531, pmagalhaescosta@gmail.com
About this study
Official title: Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy Is Timing of Preparation for Capsule Endoscopy the Key for the Best Small-bowel Cleansing?
To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion).
Read the detailed description
The image quality obtained from the wireless capsule endoscopy improves its diagnostic yield. The amount of visualized mucosa is in direct correlation with the diagnostic yield. Nonetheless, frequently, the quality of the image obtained is hampered by the presence of bubbles, debris, bile and enteric fluid. Therefore many efforts have been putted in order to eliminate this factor such as the use of prokinetics, simethicone and bowel purgatives. The latter (namely the polyethylene glycol - PEG - solution) has accumulated evidence and is, therefore, recommended by the last European guidelines. Usually, the cleansing starts and finish in the day before the capsule endoscopy ingestion.
We hypothesized that, similarly to what had become evidence to large bowel cleansing, a shorter gap between the polyethylene glycol intake and the exam could provide a better capsule endoscopy image quality and therefore gauging our diagnostic yield.
- Conditions
- Bowel Preparation
- Being tested
- Capsule endoscopy, Polyethylene Glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule endoscopyDevice
Endoscopic device
Polyethylene GlycolDrug
Also called PEG
Bowel purgative
| Study group | Role | What they receive |
|---|---|---|
| Single-dose Polyethylene Glycol regimen | Active comparator | Drug: Polyethylene Glycol Intervention: 2 liters of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion. Receives: Device: Capsule endoscopy; Drug: Polyethylene Glycol |
| Split-dose Polyethylene Glycol regimen | Experimental | Drug: Polyethylene Glycol Intervention: 1 liter of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion and another 1 liter Polyethylene Glycol will be given in the same day of Capsule Endoscopy ingestion. Receives: Device: Capsule endoscopy; Drug: Polyethylene Glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small-bowel cleanliness
The cleansing quality of the small-bowel will be evaluated according to the system validated by Brotz et al., using the quantitative index (QI), because this score is less susceptible to the subjective element. The used cut-off value accepted for an adequate small-bowel cleansing was ≥ 8 points.
Measured: at the end of capsule endoscopy exploration
Secondary outcomes (3)
The number of all the observed lesions
Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.
Measured: at the end of capsule endoscopy exploration
The clinical tolerance questionnaire
Evaluate the clinical tolerance and the acceptability of the bowel preparation with the oral polyethylene glycol solution.
Measured: at the end of capsule endoscopy exploration
The transit time
Compare gastric transit time and the small bowel transit time.
Measured: at the end of capsule endoscopy exploration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Lisboa Ocidental
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pedro Magalhães-Costa, Centro Hospitalar Lisboa Ocidental
- Investigators
- Cristina Chagas, MD, Study director, Gastroenterology Department, Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396017
- Sponsor's protocol ID
- SPLIT-PEG-CE
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rokkas T, Papaxoinis K, Triantafyllou K, Pistiolas D, Ladas SD. Does purgative preparation influence the diagnostic yield of small bowel video capsule endoscopy?: A meta-analysis. Am J Gastroenterol. 2009 Jan;104(1):219-27. doi: 10.1038/ajg.2008.63.
PubMed 19098872Ladas SD, Triantafyllou K, Spada C, Riccioni ME, Rey JF, Niv Y, Delvaux M, de Franchis R, Costamagna G; ESGE Clinical Guidelines Committee. European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases. Endoscopy. 2010 Mar;42(3):220-7. doi: 10.1055/s-0029-1243968. Epub 2010 Mar 1.
PubMed 20195992Brotz C, Nandi N, Conn M, Daskalakis C, DiMarino M, Infantolino A, Katz LC, Schroeder T, Kastenberg D. A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment. Gastrointest Endosc. 2009 Feb;69(2):262-70, 270.e1. doi: 10.1016/j.gie.2008.04.016. Epub 2008 Oct 11.
PubMed 18851851Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PubMed 23335011Magalhaes-Costa P, Carmo J, Bispo M, Santos S, Chagas C. Superiority of the Split-dose PEG Regimen for Small-Bowel Capsule Endoscopy: A Randomized Controlled Trial. J Clin Gastroenterol. 2016 Aug;50(7):e65-70. doi: 10.1097/MCG.0000000000000460.
PubMed 26646803
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy Is Timing of Preparation for Capsule Endoscopy the Key for the Best Small-bowel Cleansing?
- ClinicalTrials.gov ID
- NCT02396017
- Acronym / sponsor ID
- SPLIT-PEG-CE
- Conditions
- Bowel Preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centro Hospitalar Lisboa OcidentalOther government
- Study start
- Mar 2015
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 24 Mar 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.
To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion).
Detailed description
The image quality obtained from the wireless capsule endoscopy improves its diagnostic yield. The amount of visualized mucosa is in direct correlation with the diagnostic yield. Nonetheless, frequently, the quality of the image obtained is hampered by the presence of bubbles, debris, bile and enteric fluid. Therefore many efforts have been putted in order to eliminate this factor such as the use of prokinetics, simethicone and bowel purgatives. The latter (namely the polyethylene glycol - PEG - solution) has accumulated evidence and is, therefore, recommended by the last European guidelines. Usually, the cleansing starts and finish in the day before the capsule endoscopy ingestion.
We hypothesized that, similarly to what had become evidence to large bowel cleansing, a shorter gap between the polyethylene glycol intake and the exam could provide a better capsule endoscopy image quality and therefore gauging our diagnostic yield.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-dose Polyethylene Glycol regimen | Active comparator | Device: Capsule endoscopy, Drug: Polyethylene GlycolDrug: Polyethylene Glycol Intervention: 2 liters of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion. |
| Split-dose Polyethylene Glycol regimen | Experimental | Device: Capsule endoscopy, Drug: Polyethylene GlycolDrug: Polyethylene Glycol Intervention: 1 liter of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion and another 1 liter Polyethylene Glycol will be given in the same day of Capsule Endoscopy ingestion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients referred to our institution for CE during the study period
Key exclusion criteria (1 listed)
- inpatients, bedridden, patients with clinical evidence of active bleeding, past history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel perforation (suspected or confirmed), use of oral iron replacement therapy, severe cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any components of the preparation, patients that didn't complete the preparation protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined by the visualization of the mucosa from the duodenal bulb to the cecum), patients enrolled in other clinical studies and patients who didn't signed informed consent.
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 |
|---|---|---|
| Capsule endoscopyEndoscopic device | Device | Single-dose Polyethylene Glycol regimen, Split-dose Polyethylene Glycol regimen |
| Polyethylene GlycolAlso: PEGBowel purgative | Drug | Single-dose Polyethylene Glycol regimen, Split-dose Polyethylene Glycol regimen |
Primary outcome
Small-bowel cleanliness
Time frame: at the end of capsule endoscopy exploration
The cleansing quality of the small-bowel will be evaluated according to the system validated by Brotz et al., using the quantitative index (QI), because this score is less susceptible to the subjective element. The used cut-off value accepted for an adequate small-bowel cleansing was ≥ 8 points.
3 secondary outcomes
The number of all the observed lesions
Time frame: at the end of capsule endoscopy exploration
The clinical tolerance questionnaire
Time frame: at the end of capsule endoscopy exploration
The transit time
Time frame: at the end of capsule endoscopy exploration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Background: PubMed 19098872Rokkas T, Papaxoinis K, Triantafyllou K, Pistiolas D, Ladas SD. Does purgative preparation influence the diagnostic yield of small bowel video capsule endoscopy?: A meta-analysis. Am J Gastroenterol. 2009 Jan;104(1):219-27. doi: 10.1038/ajg.2008.63.
- Background: PubMed 20195992Ladas SD, Triantafyllou K, Spada C, Riccioni ME, Rey JF, Niv Y, Delvaux M, de Franchis R, Costamagna G; ESGE Clinical Guidelines Committee. European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases. Endoscopy. 2010 Mar;42(3):220-7. doi: 10.1055/s-0029-1243968. Epub 2010 Mar 1.
- Background: PubMed 18851851Brotz C, Nandi N, Conn M, Daskalakis C, DiMarino M, Infantolino A, Katz LC, Schroeder T, Kastenberg D. A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment. Gastrointest Endosc. 2009 Feb;69(2):262-70, 270.e1. doi: 10.1016/j.gie.2008.04.016. Epub 2008 Oct 11.
- Background: PubMed 23335011Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
- Derived from this study: PubMed 26646803Magalhaes-Costa P, Carmo J, Bispo M, Santos S, Chagas C. Superiority of the Split-dose PEG Regimen for Small-Bowel Capsule Endoscopy: A Randomized Controlled Trial. J Clin Gastroenterol. 2016 Aug;50(7):e65-70. doi: 10.1097/MCG.0000000000000460.
Related trials for Bowel Preparation
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
RecruitingPhase 4
Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before 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.
Cristina Chagas, MD study director
Gastroenterology Department, Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental
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 Capsule endoscopy and Polyethylene Glycol in people with Bowel Preparation, run by Centro Hospitalar Lisboa Ocidental at 1 site in Portugal.
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 24 Mar 2015. 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 Portugal. 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 Pedro Magalhães-Costa, MD (00351-96-3532531, pmagalhaescosta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small-bowel cleanliness (time frame: at the end of capsule endoscopy exploration). 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 NCT02396017, which also lists 5 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 24 Mar 2015.