Screening of Colonic PolypsPhase 1/2NCT01076907
Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy
A Phase 1/2 study testing Warm water in people with Screening of Colonic Polyps, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
Hypotheses 1. Loading the sigmoid colon with warm water and warm water irrigation for dealing with spasm (Study Treatment) will significantly reduce the proportion of patients complaining of abdominal discomfort compared with no water loading and waiting for spasms to subside (Control Treatment). Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening of Colonic Polyps
- What is being tested?
- Warm water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2011
- Phase
- Phase 1/2
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Accepts adult healthy male and female patients
- At least 18 years of age
- In need of colonoscopy for screening or follow up of colonic polyps
- Willing to consent and be randomized
Who cannot join
- Patients receiving outpatient narcotic treatment
- Patients who report excessive anxiety
- Patients with moderate to severe abdominal discomfort
- Unable to provide consent
- Have poor bowel preparation
Trial locations and contacts
1 site in 1 country.
United States1 site
Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center
Los Angeles, California, 91343
About this study
Official title: Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?
Hypotheses
- Loading the sigmoid colon with warm water and warm water irrigation for dealing with spasm (Study Treatment) will significantly reduce the proportion of patients complaining of abdominal discomfort compared with no water loading and waiting for spasms to subside (Control Treatment). The median discomfort score reported by the patients will be significantly lower in the group receiving the Study Treatment than the group receiving Control Treatment. Hypothesis
- Exploratory hypothesis: There are differences in secondary outcome variables when patients managed by the Study and Control Treatments are compared. Co-variables affect the primary and secondary outcome variables.
Read the detailed description
The purpose of the study is to conduct a RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing patient abdominal comfort during unsedated colonoscopy. The specific aim is to compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are the primary outcome variables. The secondary outcome variables and co-variables described below will be recorded in a prospective manner to ensure completeness of data collection. In preliminary clinical observation at VA Sepulveda ACC, 25 to 30% of VA patients accept colonoscopy without sedation. The goal of this study is to find ways of further reducing discomfort associated with unsedated colonoscopy.
- Conditions
- Screening of Colonic Polyps
- Being tested
- Warm water, Control
- Keywords
- colonoscopy, polyps
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm waterOther
Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.
ControlOther
Also called air
Air will be used instead of warm water for unsedated colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Warm water loading of sigmoid colon | Experimental | Warm water loading of sigmoid colon and irrigation when spasms occur. Receives: Other: Warm water |
| Control | Placebo comparator | No water loading, only air and waiting for spasms to subside. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
abdominal discomfort
Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
Measured: 30 days
Secondary outcomes (1)
colonoscopy-related outcomes
various procedure related measures
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startDec 2007
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Necessary equipment to perform the study arms was removed by the medical center administration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening of Colonic PolypsStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Felix W. Leung, VA Greater Los Angeles Healthcare System
- Investigators
- Felix W. Leung, MD, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076907
- Sponsor's protocol ID
- FL0055
- Status last verified
- Dec 2015
- First submitted
- 25 Feb 2010
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?
- ClinicalTrials.gov ID
- NCT01076907
- Acronym / sponsor ID
- FL0055
- Conditions
- Screening of Colonic Polyps
- Keywords
- colonoscopy, polyps
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Necessary equipment to perform the study arms was removed by the medical center administration.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- Dec 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Feb 2010 (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.
Hypotheses
- Loading the sigmoid colon with warm water and warm water irrigation for dealing with spasm (Study Treatment) will significantly reduce the proportion of patients complaining of abdominal discomfort compared with no water loading and waiting for spasms to subside (Control Treatment). The median discomfort score reported by the patients will be significantly lower in the group receiving the Study Treatment than the group receiving Control Treatment. Hypothesis
- Exploratory hypothesis: There are differences in secondary outcome variables when patients managed by the Study and Control Treatments are compared. Co-variables affect the primary and secondary outcome variables.
Detailed description
The purpose of the study is to conduct a RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing patient abdominal comfort during unsedated colonoscopy. The specific aim is to compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are the primary outcome variables. The secondary outcome variables and co-variables described below will be recorded in a prospective manner to ensure completeness of data collection. In preliminary clinical observation at VA Sepulveda ACC, 25 to 30% of VA patients accept colonoscopy without sedation. The goal of this study is to find ways of further reducing discomfort associated with unsedated colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm water loading of sigmoid colon | Experimental | Other: Warm waterWarm water loading of sigmoid colon and irrigation when spasms occur. |
| Control | Placebo comparator | Other: ControlNo water loading, only air and waiting for spasms to subside. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Accepts adult healthy male and female patients
- At least 18 years of age
- In need of colonoscopy for screening or follow up of colonic polyps
- Willing to consent and be randomized
Key exclusion criteria (5 listed)
- Patients receiving outpatient narcotic treatment
- Patients who report excessive anxiety
- Patients with moderate to severe abdominal discomfort
- Unable to provide consent
- Have poor bowel preparation
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 |
|---|---|---|
| Warm waterWarm water loading of sigmoid colon when spasms occur and waiting for them to subside. | Other | Warm water loading of sigmoid colon |
| ControlAlso: airAir will be used instead of warm water for unsedated colonoscopy. | Other | Control |
Primary outcome
abdominal discomfort
Time frame: 30 days
Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
1 secondary outcome
colonoscopy-related outcomes
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Necessary equipment to perform the study arms was removed by the medical center administration.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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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.
Felix W. Leung, MD principal investigator
VA Greater Los Angeles Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Warm water in people with Screening of Colonic Polyps, run by VA Greater Los Angeles Healthcare System at 1 site 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Dec 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 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. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Necessary equipment to perform the study arms was removed by the medical center administration.). Results are not available in the source record.
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?
abdominal discomfort (time frame: 30 days). 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 15 Dec 2015.