Abdominal PainNCT02409979
Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes
A study testing Carbon dioxide method, Water Exchange-CO2 and Water Exchange-AI in people with Abdominal Pain, run by Presidio Ospedaliero Santa Barbara at 3 sites in 3 countries.
Trial summary
Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Carbon dioxide method, Water Exchange-CO2 and Water Exchange-AI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2015to Nov 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive 18 to 80 year-old first-time diagnostic 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 consumption of bowel preparation
- moderate or severe chronic obstructive pulmonary disease requiring oxygen
- medical history of CO2 retention
- history of inflammatory bowel disease
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: Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain. This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure. Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2. Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge. The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on patients comfort and activities in the post-procedure period.
Read the detailed description
Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose bowel preparation; on demand-sedation.
Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy, water exchange-AI colonoscopy.
Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
- Conditions
- Abdominal Pain
- Being tested
- Carbon dioxide method, Water Exchange-CO2, Water Exchange-AI
- Keywords
- colonoscopy, carbon dioxide, water exchange, discomfort, colonoscopy pain
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide methodOther
Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
Water Exchange-CO2Other
Insertion using water exchange, withdrawal using CO2 insufflation.
Water Exchange-AIOther
Insertion using water exchange, withdrawal using air insufflation.
| Study group | Role | What they receive |
|---|---|---|
| Carbon dioxide method | Active comparator | Colonoscopy performed as usual, with the minimal CO2 insufflation required to aid insertion and adequate distension during withdrawal for exploration. Washing allowed as needed. Considered to be standard procedure. Receives: Other: Carbon dioxide method |
| Water Exchange-CO2 | Experimental | Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for opaque water. Air pockets and residual feces will be always aspirated. Withdrawal phase done using carbon dioxide insufflation. Receives: Other: Water Exchange-CO2 |
| Water Exchange-AI | Experimental | Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for opaque water. Air pockets and residual feces will be always aspirated. Withdrawal phase done using air insufflation. Receives: Other: Water Exchange-AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abdominal bloating sensation after colonoscopy.
Change of patients' sensation of abdominal bloating. Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients. Measured on an eleven-point Numeric Rating Scale (NRS): 0=none, 10=full bloating. Results will be recorded by telephone recall.
Measured: Within the first 24 hours after the procedure.
Secondary outcomes (10)
Change in pain score after colonoscopy.
Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients. Measured using an eleven-point NRS (0=none, 10=maximum pain). Results will be recorded by telephone recall.
Measured: Within the first 24 hours after the procedure.
Real-time insertion pain.
Pain assessed using a NRS (0=absence of pain, 2=simply "discomfort", 10=worst pain). Before the procedure, an endoscopic nurse will explain the NRS scoring system to the patients. At irregular intervals during colonoscopy (around 60 seconds) assisting nurse will ask patients about discomfort or pain. The responses will be recorded, and the maximum pain score noted. Colonoscopists not participating in gathering the informations.
Measured: 1 hour.
Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
Measured: 6 hours.
Number of flatus episodes post-procedure.
Recorded at discharge and assessed post-procedure up to 24 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
Measured: 24 hours.
Number of incontinence episodes post-procedure.
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
Measured: 6 hours.
Toilet use for bowel movement post-procedure.
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
Measured: 6 hours.
Patients' satisfaction with the procedure.
Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not satisfied, 10=very satisfied). Results will be recorded by telephone recall.
Measured: 24 hours.
Willingness to repeat colonoscopy.
Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not willing to repeat, 10=very likely to repeat). Results will be recorded by telephone recall.
Measured: 24 hours.
Interference of colonoscopy on work/normal activities the same day of the procedure.
Assessed post-procedure after 12 hours using a questionnaire given to patients (0=nothing at all, 10=a lot). Results will be recorded by telephone recall.
Measured: Up to 12 hours.
Day of work missed the day after the procedure.
Work activities missed the day after colonoscopy due to some effect of the procedure (yes, no). Assessed post-procedure after 24 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
Measured: 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abdominal 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 246 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
- NCT02409979
- Sponsor's protocol ID
- PG.2015/3645
- Other IDs
- Delibera 387/C 17 Marzo 2015
- Status last verified
- Oct 2015
- First submitted
- 23 Mar 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.
PubMed 12145595Zubarik R, Fleischer DE, Mastropietro C, Lopez J, Carroll J, Benjamin S, Eisen G. Prospective analysis of complications 30 days after outpatient colonoscopy. Gastrointest Endosc. 1999 Sep;50(3):322-8. doi: 10.1053/ge.1999.v50.97111.
PubMed 10462650de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.
PubMed 22391645Lee YC, Wang HP, Chiu HM, Lin CP, Huang SP, Lai YP, Wu MS, Chen MF, Lin JT. Factors determining post-colonoscopy abdominal pain: prospective study of screening colonoscopy in 1000 subjects. J Gastroenterol Hepatol. 2006 Oct;21(10):1575-80. doi: 10.1111/j.1440-1746.2006.04145.x.
PubMed 16928219Falt 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 22569079Cadoni S, Falt P, Gallittu P, Liggi M, Smajstrla V, Leung FW. Impact of carbon dioxide insufflation and water exchange on postcolonoscopy outcomes in patients receiving on-demand sedation: a randomized controlled trial. Gastrointest Endosc. 2017 Jan;85(1):210-218.e1. doi: 10.1016/j.gie.2016.05.021. Epub 2016 May 17.
PubMed 27207825
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02409979
- Acronym / sponsor ID
- PG.2015/3645
- Conditions
- Abdominal Pain
- Keywords
- colonoscopy, carbon dioxide, water exchange, discomfort, colonoscopy pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Presidio Ospedaliero Santa BarbaraUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Apr 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.
Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain. This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure. Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2. Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge. The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on patients comfort and activities in the post-procedure period.
Detailed description
Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose bowel preparation; on demand-sedation.
Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy, water exchange-AI colonoscopy.
Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbon dioxide method | Active comparator | Other: Carbon dioxide methodColonoscopy performed as usual, with the minimal CO2 insufflation required to aid insertion and adequate distension during withdrawal for exploration. Washing allowed as needed. Considered to be standard procedure. |
| 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 a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for opaque water. Air pockets and residual feces will be always aspirated. Withdrawal phase done using carbon dioxide 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 a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for opaque water. Air pockets and residual feces will be always aspirated. Withdrawal phase done using air insufflation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start procedure without premedication
Key exclusion criteria (8 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 consumption 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 |
|---|---|---|
| Carbon dioxide methodInsufflation with CO2 during insertion and withdrawal phases of colonoscopy. | Other | Carbon dioxide method |
| Water Exchange-CO2Insertion using water exchange, withdrawal using CO2 insufflation. | Other | Water Exchange-CO2 |
| Water Exchange-AIInsertion using water exchange, withdrawal using air insufflation. | Other | Water Exchange-AI |
Primary outcome
Change in abdominal bloating sensation after colonoscopy.
Time frame: Within the first 24 hours after the procedure.
Change of patients' sensation of abdominal bloating. Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients. Measured on an eleven-point Numeric Rating Scale (NRS): 0=none, 10=full bloating. Results will be recorded by telephone recall.
10 secondary outcomes
Change in pain score after colonoscopy.
Time frame: Within the first 24 hours after the procedure.
Real-time insertion pain.
Time frame: 1 hour.
Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.
Time frame: 6 hours.
Number of flatus episodes post-procedure.
Time frame: 24 hours.
Number of incontinence episodes post-procedure.
Time frame: 6 hours.
Toilet use for bowel movement post-procedure.
Time frame: 6 hours.
Patients' satisfaction with the procedure.
Time frame: 24 hours.
Willingness to repeat colonoscopy.
Time frame: 24 hours.
Interference of colonoscopy on work/normal activities the same day of the procedure.
Time frame: Up to 12 hours.
Day of work missed the day after the procedure.
Time frame: 24 hours.
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 5 Nov 2015.
- Results publication: PubMed 12145595Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.
- Results publication: PubMed 10462650Zubarik R, Fleischer DE, Mastropietro C, Lopez J, Carroll J, Benjamin S, Eisen G. Prospective analysis of complications 30 days after outpatient colonoscopy. Gastrointest Endosc. 1999 Sep;50(3):322-8. doi: 10.1053/ge.1999.v50.97111.
- Results publication: PubMed 22391645de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.
- Results publication: PubMed 16928219Lee YC, Wang HP, Chiu HM, Lin CP, Huang SP, Lai YP, Wu MS, Chen MF, Lin JT. Factors determining post-colonoscopy abdominal pain: prospective study of screening colonoscopy in 1000 subjects. J Gastroenterol Hepatol. 2006 Oct;21(10):1575-80. doi: 10.1111/j.1440-1746.2006.04145.x.
- Results publication: 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.
- Derived from this study: PubMed 27207825Cadoni S, Falt P, Gallittu P, Liggi M, Smajstrla V, Leung FW. Impact of carbon dioxide insufflation and water exchange on postcolonoscopy outcomes in patients receiving on-demand sedation: a randomized controlled trial. Gastrointest Endosc. 2017 Jan;85(1):210-218.e1. doi: 10.1016/j.gie.2016.05.021. Epub 2016 May 17.
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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 Carbon dioxide method, Water Exchange-CO2 and Water Exchange-AI in people with Abdominal Pain, 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 8 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 5 Nov 2015. 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?
Change in abdominal bloating sensation after colonoscopy. (time frame: Within the first 24 hours after the procedure.). 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 NCT02409979, which also lists 6 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 5 Nov 2015.