Esophagoscopy TechniquesNCT01563744
EGD-assisted Bowel Preparation for Colonoscopy
A study testing EGD-assisted administration of colonoscopy prep in people with Esophagoscopy Techniques and Colonoscopy, run by Rockford Gastroenterology Associates at 2 sites in United States.
Trial summary
Adequate bowel preparation is of critical importance for colonoscopy. Particularly among hospitalized patients, inadequate bowel preparation for colonoscopy may arise due to patient intolerance to prescribed laxative regimen, elderly population, and co-existing conditions that impair the ability to ingest a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophagoscopy Techniques, Colonoscopy
- What is being tested?
- EGD-assisted administration of colonoscopy prep
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hospitalized patients
- having EGD and expected to have colonoscopy the following day
- written informed consent
Who cannot join
- unable to tolerate EGD-assisted prep administration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
SwedishAmerican Hospital
Rockford, Illinois, 61104
St. Anthony Medical Center
Rockford, Illinois, 61108
About this study
Adequate bowel preparation is of critical importance for colonoscopy. Particularly among hospitalized patients, inadequate bowel preparation for colonoscopy may arise due to patient intolerance to prescribed laxative regimen, elderly population, and co-existing conditions that impair the ability to ingest a large-volume laxative regimen. Improvements in bowel preparation for colonoscopy in hospitalized patients would likely improve patient care and reduce hospital costs. The purpose of this study is to determine if administering a portion of the bowel purgative via EGD could improve colonoscopy preparation in hospitalized patients.
Read the detailed description
In this randomized controlled trial in hospitalized patients, patients in whom colonoscopy was anticipated the day following EGD were consented and randomized to either standard prep by mouth (split-dose PEG) or intervention group (instillation of the first 2 liters of Nulytely solution through the channel of the endoscope into the duodenal bulb, then continue standard prep). Data is collected on quality of prep and patient satisfaction in both groups.
- Conditions
- Esophagoscopy Techniques, Colonoscopy
- Being tested
- EGD-assisted administration of colonoscopy prep, Control Group received standard prep by oral administration
- Keywords
- colonoscopy, bowel preparation, tolerability, EGD-assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGD-assisted administration of colonoscopy prepProcedure or surgery
Interventional group receive the first 2 liters of prep solution during EGD through the scope channel if colonoscopy expected the following day.
Control Group received standard prep by oral administrationProcedure or surgery
Control group receive standard oral colonoscopy prep.
| Study group | Role | What they receive |
|---|---|---|
| EGD-assisted colonoscopy prep | Experimental | 2 liters of polyethylene glycol instilled through the channel of the endoscope during EGD when colonoscopy expected the following day. Patients follow a clear liquid diet, then ingest an addition 1 liter polyethylene glycol 4 hours prior to colonoscopy. Patients are also given a tap water enema 1 hour prior to colonoscopy. Receives: Procedure: EGD-assisted administration of colonoscopy prep |
| Standard Colonoscopy Prep | Active comparator | Split-dose polyethylene glycol (2 liters pm prior to colonoscopy, 1 liter 4 hours prior to colonoscopy)), clear liquid diet, metoclopramide 10 mg IV 30 minutes prior to procedure, tap water enema 1 hr prior to colonoscopy Receives: Procedure: Control Group received standard prep by oral administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation
Quality of prep was assessed using the Ottawa bowel preparation scale (Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest endosc 2004;59:482-6)
Measured: Twenty four to 48 hours - from time of consent prior to EGD until end of colonoscopy performed the following day
Secondary outcomes (1)
Patient tolerance of bowel preparation
Patients in both groups were asked to indicate if the bowel prep was easy, slightly difficult, moderately difficult, extremely difficult, or if they were unable to complete the prep as directed.
Measured: administered just prior to sedation for colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startAug 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagoscopy TechniquesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockford Gastroenterology Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert L. Barclay, MD, Principal investigator, Rockford Gastroenterology Associates, University of Illinois College of Medicine, Rockford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563744
- Sponsor's protocol ID
- EGD-assisted 2012
- Status last verified
- Apr 2012
- First submitted
- 23 Mar 2012
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EGD-assisted Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT01563744
- Acronym / sponsor ID
- EGD-assisted 2012
- Conditions
- Esophagoscopy Techniques, Colonoscopy
- Keywords
- colonoscopy, bowel preparation, tolerability, EGD-assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Rockford Gastroenterology AssociatesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Mar 2012 (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.
Adequate bowel preparation is of critical importance for colonoscopy. Particularly among hospitalized patients, inadequate bowel preparation for colonoscopy may arise due to patient intolerance to prescribed laxative regimen, elderly population, and co-existing conditions that impair the ability to ingest a large-volume laxative regimen. Improvements in bowel preparation for colonoscopy in hospitalized patients would likely improve patient care and reduce hospital costs. The purpose of this study is to determine if administering a portion of the bowel purgative via EGD could improve colonoscopy preparation in hospitalized patients.
Detailed description
In this randomized controlled trial in hospitalized patients, patients in whom colonoscopy was anticipated the day following EGD were consented and randomized to either standard prep by mouth (split-dose PEG) or intervention group (instillation of the first 2 liters of Nulytely solution through the channel of the endoscope into the duodenal bulb, then continue standard prep). Data is collected on quality of prep and patient satisfaction in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGD-assisted colonoscopy prep | Experimental | Procedure: EGD-assisted administration of colonoscopy prep2 liters of polyethylene glycol instilled through the channel of the endoscope during EGD when colonoscopy expected the following day. Patients follow a clear liquid diet, then ingest an addition 1 liter polyethylene glycol 4 hours prior to colonoscopy. Patients are also given a tap water enema 1 hour prior to colonoscopy. |
| Standard Colonoscopy Prep | Active comparator | Procedure: Control Group received standard prep by oral administrationSplit-dose polyethylene glycol (2 liters pm prior to colonoscopy, 1 liter 4 hours prior to colonoscopy)), clear liquid diet, metoclopramide 10 mg IV 30 minutes prior to procedure, tap water enema 1 hr prior to colonoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- hospitalized patients
- having EGD and expected to have colonoscopy the following day
- written informed consent
Key exclusion criteria (1 listed)
- unable to tolerate EGD-assisted prep administration
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 |
|---|---|---|
| EGD-assisted administration of colonoscopy prepInterventional group receive the first 2 liters of prep solution during EGD through the scope channel if colonoscopy expected the following day. | Procedure or surgery | EGD-assisted colonoscopy prep |
| Control Group received standard prep by oral administrationControl group receive standard oral colonoscopy prep. | Procedure or surgery | Standard Colonoscopy Prep |
Primary outcome
Quality of bowel preparation
Time frame: Twenty four to 48 hours - from time of consent prior to EGD until end of colonoscopy performed the following day
Quality of prep was assessed using the Ottawa bowel preparation scale (Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest endosc 2004;59:482-6)
1 secondary outcome
Patient tolerance of bowel preparation
Time frame: administered just prior to sedation for colonoscopy
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 19 Apr 2016.
- Individual participant dataSharing planned: No
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.
Robert L. Barclay, MD principal investigator
Rockford Gastroenterology Associates, University of Illinois College of Medicine, Rockford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EGD-assisted administration of colonoscopy prep in people with Esophagoscopy Techniques and Colonoscopy, run by Rockford Gastroenterology Associates at 2 sites 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 3 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: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quality of bowel preparation (time frame: Twenty four to 48 hours - from time of consent prior to EGD until end of colonoscopy performed the following day). 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 19 Apr 2016.