Clinical trial NCT02409979: Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes
Official title: Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Keywords: colonoscopy
carbon dioxide
water exchange
discomfort
colonoscopy pain
Lead sponsor: Presidio Ospedaliero Santa Barbara
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start procedure without premedication

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in abdominal bloating sensation after colonoscopy.
timeFrame: Within the first 24 hours after the procedure.
Secondary outcomes:
measure: Change in pain score after colonoscopy.
timeFrame: Within the first 24 hours after the procedure.
measure: Real-time insertion pain.
timeFrame: 1 hour.
measure: Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.
timeFrame: 6 hours.
measure: Number of flatus episodes post-procedure.
timeFrame: 24 hours.
measure: Number of incontinence episodes post-procedure.
timeFrame: 6 hours.
measure: Toilet use for bowel movement post-procedure.
timeFrame: 6 hours.
measure: Patients' satisfaction with the procedure.
timeFrame: 24 hours.
measure: Willingness to repeat colonoscopy.
timeFrame: 24 hours.
measure: Interference of colonoscopy on work/normal activities the same day of the procedure.
timeFrame: Up to 12 hours.
measure: Day of work missed the day after the procedure.
timeFrame: 24 hours.
Other outcomes:
measure: Cecal intubation rate.
timeFrame: 1 hour.
measure: Cecal intubation time.
timeFrame: 1 hour.
measure: Total procedure time.
timeFrame: 1 hour.
measure: Adenoma detection rate.
timeFrame: 9 months.
measure: On-demand sedation.
timeFrame: 1 hour.
measure: Oxygen desaturation.
timeFrame: 1 hour.
measure: Vagal reaction.
timeFrame: 1 hour.
Locations:
city: Los Angeles
country: United States
facility: Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
state: California
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center, Vìtkovice Hospital
city: Iglesias
country: Italy
facility: Digestive Endoscopy Unit, Ospedale S. Barbara
state: CI
Study officials:
affiliation: S. Barbara Hospital, Iglesias (CI) Italy
name: Sergio Cadoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Zubarik 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.
citation: de 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.
citation: Lee 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.
citation: 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.
citation: Cadoni 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.