PainNCT01954862
Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy
A study testing Air Insufflation method., CO2 insufflation and Water Immersion/CO2 in people with Pain and Colorectal Adenomas, run by Presidio Ospedaliero Santa Barbara at 3 sites in 3 countries.
Trial summary
Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Colorectal Adenomas, Colorectal Cancer
- What is being tested?
- Air Insufflation method., CO2 insufflation and Water Immersion/CO2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2013to Jul 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive 18 to 85 year-old diagnostic in-patients and outpatients agreeing to start procedure without premedication.
Who cannot join
- Patient unwillingness to start the procedure without sedation/analgesia
- previous colorectal surgery
- proctosigmoidoscopy or bidirectional endoscopy
- patient refusal or inability to provide informed consent
- inadequate assumption of bowel preparation
- moderate or severe chronic obstructive pulmonary disease requiring oxygen
- medical history of CO2 retention
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
Los Angeles, California, 91343
About this study
Official title: Comparison of Methods for Luminal Distention for on Demand Sedation Colonoscopy: Air Insufflation, Carbon Dioxide and Water-aided Colonoscopy. A Randomized Controlled Trial.
Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration. AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion of water to facilitate insertion to the cecum.
WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water is infused during the insertion phase of colonoscopy, with removal of infused water predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails complete exclusion of insufflation, removal of residual colonic air pockets and feces, and suction of infused water predominantly during insertion to minimize distention. During the withdrawal phase insufflation is used to distend the colonic lumen.
Read more
In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or CO2 insufflation were employed.
Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation during withdrawal) were effective in both studies in decreasing sedation requirement, pain and tolerance scores, with patients' higher willingness to repeat the procedure.
Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI.
In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI methods will decrease pain score during colonoscopy, with reduction of sedation requirement, and that WE will achieve the best result. This comparative study has also the aim to test the respective peculiarities of each method.
Read the detailed description
Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with air insufflation, CO2, Water Immersion/CO2, Water Exchange/CO2, Water Immersion/AI and Water Exchange/AI to aid insertion of colonoscope; split dose bowel preparation; on demand-sedation.
Control method: Air insufflation colonoscopy. Study methods: CO2 colonoscopy, Water Immersion/CO2 colonoscopy, Water Exchange/CO2 colonoscopy, Water Immersion/AI colonoscopy, Water Exchange/AI colonoscopy.
Population: Consecutive 18 to 85 year-old diagnostic in-patients and outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
Primary outcome: Maximum pain score recorded during colonoscopy. Secondary outcomes: Cecal intubation rate and time, total procedure time (including biopsy and/or polypectomy), need for sedation and its dosage, overall pain score at discharge. In addition, Adenoma Detection Rate, Mean Adenomas per Procedure, position changes, amount of infused and suctioned water during insertion and withdrawal will be recorded. Bloating after examination and at discharge and patient willingness to repeat the examination will be evaluated.
- Conditions
- Pain, Colorectal Adenomas, Colorectal Cancer
- Being tested
- Air Insufflation method., CO2 insufflation, Water Immersion/CO2, Water Exchange/CO2, Water Immersion/AI
- Keywords
- Water-aided colonoscopy, Water Immersion colonoscopy, Water Exchange colonoscopy, Carbon-dioxide colonoscopy, Painless unsedated colonoscopy, Adenoma detection rate, Mean Adenomas per Procedure
- Medical subject headings
- Pain, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Insufflation method.Other
Air Insufflation method.
CO2 insufflationOther
CO2 insufflation.
Water Immersion/CO2Other
Water Immersion during insertion, CO2 insufflation during withdrawal.
Water Exchange/CO2Other
Water Exchange during insertion, CO2 insufflation during withdrawal.
Water Immersion/AIOther
Water Immersion during insertion, AI insufflation during withdrawal.
Water Exchange/AIOther
Water Exchange during insertion, AI insufflation during withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| Air insufflation method. | Active comparator | Colonoscopy performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure. Receives: Other: Air Insufflation method. |
| CO2 insufflation | Experimental | Colonoscopy performed with CO2 insufflation using the insufflation unit, allowing for washing as needed. Receives: Other: CO2 insufflation |
| Water Immersion/CO2 | Experimental | Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if >3) if the lumen cannot be seen. Withdrawal phase done using CO2 insufflation. Receives: Other: Water Immersion/CO2 |
| Water Exchange/CO2 | Experimental | Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using CO2 insufflation. Receives: Other: Water Exchange/CO2 |
| Water Immersion/AI | Experimental | Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if >3) if the lumen cannot be seen. Withdrawal phase done using room air insufflation. Receives: Other: Water Immersion/AI |
| Water Exchange/AI | Experimental | Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using room air insufflation. Receives: Other: Water Exchange/AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain score recorded during colonoscopy.
Pain assessed using a visual analogue scale (VAS) with a score 0=absence of pain, 2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patients. Every 60 seconds during colonoscopy patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.
Measured: 1 hour
Secondary outcomes (7)
Overall pain after the procedure.
After the procedure and at discharge from the Endoscopy Unit, an assistant nurse blinded to the procedure will ask patients about overall pain using the same VAS when neither the endoscopist nor the assistant nurse who performed the colonoscopy will be present. Patients will be asked to quantify the degree of pain experienced and to place a mark over the VAS accordingly.
Measured: 1 hour.
Cecal intubation rate.
Cecal intubation will be defined as passage of the tip of the colonoscope beyond the ileocecal valve so that the medial wall of the cecum proximal to the ileocecal valve will be observed.
Measured: 1 hour
Cecal intubation time.
Cecal intubation time will be defined as the time for passage of the colonoscope from the rectum to the cecum.
Measured: 1 hour.
Total procedure time.
Total procedure time (including time required for polyp resection or biopsy).
Measured: 1 hour.
Adenoma detection rate.
Proportion of subjects with at least one adenoma of any size.
Measured: 15 months.
Mean adenomas per procedure.
Total number of adenomas resected per subject.
Measured: 15 months.
Advanced adenomas.
Total number of advanced adenomas: diameter ≥10mm, or high grade dysplasia, or with ≥20% villous components.
Measured: 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presidio Ospedaliero Santa Barbara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara
- Investigators
- Sergio Cadoni, MD, Principal investigator, S. Barbara Hospital, Iglesias (CI), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954862
- Sponsor's protocol ID
- PG. 2013/3403
- Status last verified
- Jul 2014
- First submitted
- 27 Sep 2013
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
PubMed 22569079Amato A, Radaelli F, Paggi S, Baccarin A, Spinzi G, Terruzzi V. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2013 Apr;56(4):511-8. doi: 10.1097/DCR.0b013e318279addd.
PubMed 23478620Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
PubMed 22898423Rabenstein T, Radaelli F, Zolk O. Warm water infusion colonoscopy: a review and meta-analysis. Endoscopy. 2012 Oct;44(10):940-51. doi: 10.1055/s-0032-1310157. Epub 2012 Sep 17.
PubMed 22987214Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.
PubMed 23931857Wu J, Hu B. The role of carbon dioxide insufflation in colonoscopy: a systematic review and meta-analysis. Endoscopy. 2012 Feb;44(2):128-36. doi: 10.1055/s-0031-1291487. Epub 2012 Jan 23.
PubMed 22271023Dellon ES, Hawk JS, Grimm IS, Shaheen NJ. The use of carbon dioxide for insufflation during GI endoscopy: a systematic review. Gastrointest Endosc. 2009 Apr;69(4):843-9. doi: 10.1016/j.gie.2008.05.067. Epub 2009 Jan 18.
PubMed 19152906Cadoni S, Falt P, Gallittu P, Liggi M, Mura D, Smajstrla V, Erriu M, Leung FW. Water Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1972-80.e1-3. doi: 10.1016/j.cgh.2015.04.178. Epub 2015 May 5.
PubMed 25956838
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods for Luminal Distention for on Demand Sedation Colonoscopy: Air Insufflation, Carbon Dioxide and Water-aided Colonoscopy. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01954862
- Acronym / sponsor ID
- PG. 2013/3403
- Conditions
- Pain, Colorectal Adenomas, Colorectal Cancer
- Keywords
- Water-aided colonoscopy, Water Immersion colonoscopy, Water Exchange colonoscopy, Carbon-dioxide colonoscopy, Painless unsedated colonoscopy, Adenoma detection rate, Mean Adenomas per Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- Presidio Ospedaliero Santa BarbaraUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Oct 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.
Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration. AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion of water to facilitate insertion to the cecum.
WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water is infused during the insertion phase of colonoscopy, with removal of infused water predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails complete exclusion of insufflation, removal of residual colonic air pockets and feces, and suction of infused water predominantly during insertion to minimize distention. During the withdrawal phase insufflation is used to distend the colonic lumen.
In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or CO2 insufflation were employed.
Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation during withdrawal) were effective in both studies in decreasing sedation requirement, pain and tolerance scores, with patients' higher willingness to repeat the procedure.
Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI.
In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI methods will decrease pain score during colonoscopy, with reduction of sedation requirement, and that WE will achieve the best result. This comparative study has also the aim to test the respective peculiarities of each method.
Detailed description
Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with air insufflation, CO2, Water Immersion/CO2, Water Exchange/CO2, Water Immersion/AI and Water Exchange/AI to aid insertion of colonoscope; split dose bowel preparation; on demand-sedation.
Control method: Air insufflation colonoscopy. Study methods: CO2 colonoscopy, Water Immersion/CO2 colonoscopy, Water Exchange/CO2 colonoscopy, Water Immersion/AI colonoscopy, Water Exchange/AI colonoscopy.
Population: Consecutive 18 to 85 year-old diagnostic in-patients and outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
Primary outcome: Maximum pain score recorded during colonoscopy. Secondary outcomes: Cecal intubation rate and time, total procedure time (including biopsy and/or polypectomy), need for sedation and its dosage, overall pain score at discharge. In addition, Adenoma Detection Rate, Mean Adenomas per Procedure, position changes, amount of infused and suctioned water during insertion and withdrawal will be recorded. Bloating after examination and at discharge and patient willingness to repeat the examination will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Air insufflation method. | Active comparator | Other: Air Insufflation method.Colonoscopy performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure. |
| CO2 insufflation | Experimental | Other: CO2 insufflationColonoscopy performed with CO2 insufflation using the insufflation unit, allowing for washing as needed. |
| Water Immersion/CO2 | Experimental | Other: Water Immersion/CO2Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if >3) if the lumen cannot be seen. Withdrawal phase done using CO2 insufflation. |
| Water Exchange/CO2 | Experimental | Other: Water Exchange/CO2Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using CO2 insufflation. |
| Water Immersion/AI | Experimental | Other: Water Immersion/AIInfusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if >3) if the lumen cannot be seen. Withdrawal phase done using room air insufflation. |
| Water Exchange/AI | Experimental | Other: Water Exchange/AIInsufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using room air insufflation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive 18 to 85 year-old diagnostic in-patients and outpatients agreeing to start procedure without premedication.
Key exclusion criteria (7 listed)
- Patient unwillingness to start the procedure without sedation/analgesia
- previous colorectal surgery
- proctosigmoidoscopy or bidirectional endoscopy
- patient refusal or inability to provide informed consent
- inadequate assumption of 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 |
|---|---|---|
| Air Insufflation method.Air Insufflation method. | Other | Air insufflation method. |
| CO2 insufflationCO2 insufflation. | Other | CO2 insufflation |
| Water Immersion/CO2Water Immersion during insertion, CO2 insufflation during withdrawal. | Other | Water Immersion/CO2 |
| Water Exchange/CO2Water Exchange during insertion, CO2 insufflation during withdrawal. | Other | Water Exchange/CO2 |
| Water Immersion/AIWater Immersion during insertion, AI insufflation during withdrawal. | Other | Water Immersion/AI |
| Water Exchange/AIWater Exchange during insertion, AI insufflation during withdrawal. | Other | Water Exchange/AI |
Primary outcome
Maximum pain score recorded during colonoscopy.
Time frame: 1 hour
Pain assessed using a visual analogue scale (VAS) with a score 0=absence of pain, 2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patients. Every 60 seconds during colonoscopy patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.
7 secondary outcomes
Overall pain after the procedure.
Time frame: 1 hour.
Cecal intubation rate.
Time frame: 1 hour
Cecal intubation time.
Time frame: 1 hour.
Total procedure time.
Time frame: 1 hour.
Adenoma detection rate.
Time frame: 15 months.
Mean adenomas per procedure.
Time frame: 15 months.
Advanced adenomas.
Time frame: 15 months.
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 31 Jul 2014.
- Background: PubMed 22569079Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
- Background: PubMed 23478620Amato A, Radaelli F, Paggi S, Baccarin A, Spinzi G, Terruzzi V. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2013 Apr;56(4):511-8. doi: 10.1097/DCR.0b013e318279addd.
- Background: PubMed 22898423Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
- Background: PubMed 22987214Rabenstein T, Radaelli F, Zolk O. Warm water infusion colonoscopy: a review and meta-analysis. Endoscopy. 2012 Oct;44(10):940-51. doi: 10.1055/s-0032-1310157. Epub 2012 Sep 17.
- Background: PubMed 23931857Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.
- Background: PubMed 22271023Wu J, Hu B. The role of carbon dioxide insufflation in colonoscopy: a systematic review and meta-analysis. Endoscopy. 2012 Feb;44(2):128-36. doi: 10.1055/s-0031-1291487. Epub 2012 Jan 23.
- Background: PubMed 19152906Dellon ES, Hawk JS, Grimm IS, Shaheen NJ. The use of carbon dioxide for insufflation during GI endoscopy: a systematic review. Gastrointest Endosc. 2009 Apr;69(4):843-9. doi: 10.1016/j.gie.2008.05.067. Epub 2009 Jan 18.
- Derived from this study: PubMed 25956838Cadoni S, Falt P, Gallittu P, Liggi M, Mura D, Smajstrla V, Erriu M, Leung FW. Water Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1972-80.e1-3. doi: 10.1016/j.cgh.2015.04.178. Epub 2015 May 5.
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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.
Sergio Cadoni, MD principal investigator
S. Barbara Hospital, Iglesias (CI), Italy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Insufflation method., CO2 insufflation and Water Immersion/CO2 in people with Pain and Colorectal Adenomas, run by Presidio Ospedaliero Santa Barbara at 3 sites in 3 countries.
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 7 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 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Czechia, Italy. 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?
Maximum pain score recorded during colonoscopy. (time frame: 1 hour). 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 NCT01954862, which also lists 8 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 31 Jul 2014.