Screening for Colon CancerNCT01790425
Randomized Controlled Trial Comparing Water vs. Air Method for Performing Colonoscopy in Adult Female Subjects
A study testing to infuse water into colon to open the lumen for water infusion colonoscopy and Air colonoscopy in people with Screening for Colon Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
This is a prospective , single center, investigator initiated, randomized controlled trial to compare two methods of performing colonoscopy by experienced colonoscopist. Potential female subjects presenting for colonoscopy at UCD GI Lab will be presented with the study option and will be enrolled if they sign the… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Screening for Colon Cancer
- What is being tested?
- to infuse water into colon to open the lumen for water infusion colonoscopy and Air colonoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2015
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -All female patients between the ages of 18 to 80 years scheduled for colonoscopy at UC Davis GI Lab.
Who cannot join
- Patients who refuse to be randomized to the air or water colonoscopy method.
- Patients who are unable to respond to study questionnaires.
- Patients with partial colon resection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
This is a prospective , single center, investigator initiated, randomized controlled trial to compare two methods of performing colonoscopy by experienced colonoscopist. Potential female subjects presenting for colonoscopy at UCD GI Lab will be presented with the study option and will be enrolled if they sign the informed consent.
In recent years, the water infusion method has been reported to have several beneficial effects when studied in veteran patients. These include: significant reduction in discomfort to permit a significantly higher percentage (98% vs. 76%) of veterans to complete scheduled unsedated colonoscopy, lower sedation medication requirement when they accepted the option of minimal pre-medication sedation, more patients completing without sedation (78% vs 54%) when they accepted the on demand sedation and an increase in the yield of adenomas (a type of cancer seen in the colon) in screening and surveillance colonoscopy. Reviewers of the method have repeatedly called for studies using the method in female patients to confirm or refute the findings as most of the veteran patients are male patients.
Read the detailed description
Study Aim Our aim is to perform a randomized controlled trial comparing air insufflation colonoscopy (conventional method ) vs. water infusion colonoscopy ( study method ) in non veteran female subjects presenting for colonoscopy . Subjects will be randomized 1:1 like the flip of coin.
Study Design This is a prospective, single center, investigator initiated, randomized controlled trial (RCT) to compare the study method (water infusion colonoscopy) with conventional method (air insufflation colonoscopy "pump air to dilate the colon to visualize the colon mucosa) in female patients by experienced colonoscopist. Patients will be classified ASA 1 (No organic, physiologic, biomedical or psychiatric disturbance) and ASA 2 (Mild to moderate systemic diseases which are well controlled including hypertension, diabetes mellitus, asthma, age 70 and over) before colonoscopy procedure.
Research Methods and Procedures The air (conventional) method: Air is pumped gently (insufflation) into the colon will be used to open the inside space of the colon and aid in colonoscope insertion The water (study) method: Warm water (body temperature) will be pumped into the colon in place of air to open the inside of space of the colon and aid in colonoscope insertion After insertion, both methods may use any of the following procedures to advance the colonoscope in to the colon: colonoscope shortening maneuver, abdominal compression, by the assistant, and change of patient position. In both methods air insufflation will be used to distend the colon for inspection, biopsy and polypectomy. Washing of the stool covered mucosa and inspection behind the folds will be performed systematically. After turn around in the rectum, residual air and water will be removed by suction.
Data gathering instruments used in the VA studies will be employed (subject interview questions are attached). Statistical analyses similar to those used in the previous VA studies (Student's t tests, Fischer's exact test, Mann-Whitney U test, etc) will be used to analyze the data.
Biopsy and polypectomy will be performed as usual and all tissues will be submitted for routine histological assessment and the pathology will be recorded.
- Conditions
- Screening for Colon Cancer
- Being tested
- to infuse water into colon to open the lumen for water infusion colonoscopy, Air colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to infuse water into colon to open the lumen for water infusion colonoscopyProcedure or surgery
Also called Water colonoscopy
Air colonoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| water colonoscopy | Experimental | The water (study) method: Warm water (body temperature) will be infused into colon to open the lumen for water infusion colonoscopy. Higher rate of complete colonoscopy will be achieved. Receives: Procedure: to infuse water into colon to open the lumen for water infusion colonoscopy |
| Air Colonoscopy | Active comparator | The air (conventional) method: Air is pumped gently (insufflation) into the colon will be used to open the inside space of the colon and aid in colonoscope insertion Receives: Procedure: Air colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal intubation
Examination of the cecum by endoscopy
Measured: Three years
Secondary outcomes (1)
Amount of opiate and benzodiazepines used for sedation.
The total amount of opiate (either demerol of fentanyl) used for sedation.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startAug 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening for Colon CancerStudies 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surinder Mann, M.D., Principal investigator, UCD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790425
- Sponsor's protocol ID
- 319719
- Other IDs
- UCD IRB # 319719
- Status last verified
- Jun 2017
- First submitted
- 17 Jan 2013
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Water vs. Air Method for Performing Colonoscopy in Adult Female Subjects
- ClinicalTrials.gov ID
- NCT01790425
- Acronym / sponsor ID
- 319719
- Conditions
- Screening for Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Feb 2013 (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.
This is a prospective , single center, investigator initiated, randomized controlled trial to compare two methods of performing colonoscopy by experienced colonoscopist. Potential female subjects presenting for colonoscopy at UCD GI Lab will be presented with the study option and will be enrolled if they sign the informed consent.
In recent years, the water infusion method has been reported to have several beneficial effects when studied in veteran patients. These include: significant reduction in discomfort to permit a significantly higher percentage (98% vs. 76%) of veterans to complete scheduled unsedated colonoscopy, lower sedation medication requirement when they accepted the option of minimal pre-medication sedation, more patients completing without sedation (78% vs 54%) when they accepted the on demand sedation and an increase in the yield of adenomas (a type of cancer seen in the colon) in screening and surveillance colonoscopy. Reviewers of the method have repeatedly called for studies using the method in female patients to confirm or refute the findings as most of the veteran patients are male patients.
Detailed description
Study Aim Our aim is to perform a randomized controlled trial comparing air insufflation colonoscopy (conventional method ) vs. water infusion colonoscopy ( study method ) in non veteran female subjects presenting for colonoscopy . Subjects will be randomized 1:1 like the flip of coin.
Study Design This is a prospective, single center, investigator initiated, randomized controlled trial (RCT) to compare the study method (water infusion colonoscopy) with conventional method (air insufflation colonoscopy "pump air to dilate the colon to visualize the colon mucosa) in female patients by experienced colonoscopist. Patients will be classified ASA 1 (No organic, physiologic, biomedical or psychiatric disturbance) and ASA 2 (Mild to moderate systemic diseases which are well controlled including hypertension, diabetes mellitus, asthma, age 70 and over) before colonoscopy procedure.
Research Methods and Procedures The air (conventional) method: Air is pumped gently (insufflation) into the colon will be used to open the inside space of the colon and aid in colonoscope insertion The water (study) method: Warm water (body temperature) will be pumped into the colon in place of air to open the inside of space of the colon and aid in colonoscope insertion After insertion, both methods may use any of the following procedures to advance the colonoscope in to the colon: colonoscope shortening maneuver, abdominal compression, by the assistant, and change of patient position. In both methods air insufflation will be used to distend the colon for inspection, biopsy and polypectomy. Washing of the stool covered mucosa and inspection behind the folds will be performed systematically. After turn around in the rectum, residual air and water will be removed by suction.
Data gathering instruments used in the VA studies will be employed (subject interview questions are attached). Statistical analyses similar to those used in the previous VA studies (Student's t tests, Fischer's exact test, Mann-Whitney U test, etc) will be used to analyze the data.
Biopsy and polypectomy will be performed as usual and all tissues will be submitted for routine histological assessment and the pathology will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water colonoscopy | Experimental | Procedure: to infuse water into colon to open the lumen for water infusion colonoscopyThe water (study) method: Warm water (body temperature) will be infused into colon to open the lumen for water infusion colonoscopy. Higher rate of complete colonoscopy will be achieved. |
| Air Colonoscopy | Active comparator | Procedure: Air colonoscopyThe air (conventional) method: Air is pumped gently (insufflation) into the colon will be used to open the inside space of the colon and aid in colonoscope insertion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -All female patients between the ages of 18 to 80 years scheduled for colonoscopy at UC Davis GI Lab.
Key exclusion criteria (3 listed)
- Patients who refuse to be randomized to the air or water colonoscopy method.
- Patients who are unable to respond to study questionnaires.
- Patients with partial colon resection
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 |
|---|---|---|
| to infuse water into colon to open the lumen for water infusion colonoscopyAlso: Water colonoscopy | Procedure or surgery | water colonoscopy |
| Air colonoscopy | Procedure or surgery | Air Colonoscopy |
Primary outcome
Cecal intubation
Time frame: Three years
Examination of the cecum by endoscopy
1 secondary outcome
Amount of opiate and benzodiazepines used for sedation.
Time frame: Three years
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 Jun 2017.
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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.
Surinder Mann, M.D. principal investigator
UCD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing to infuse water into colon to open the lumen for water infusion colonoscopy and Air colonoscopy in people with Screening for Colon Cancer, run by University of California, Davis 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 1 inclusion and 3 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 Jun 2017. 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. 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?
Cecal intubation (time frame: Three years). 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 Jun 2017.