Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes

Abdominal Pain Clinical Trial

Official title:

Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409979
• Other study ID #: PG.2015/3645
• Secondary ID: Delibera 387/C 1
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: November 4, 2015
• Start date: April 2015
• Est. completion date: November 2015

Study information

• Verified date: October 2015
• Source: Presidio Ospedaliero Santa Barbara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Other:
• Carbon dioxide method
Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
• Water Exchange-CO2
Insertion using water exchange, withdrawal using CO2 insufflation.
• Water Exchange-AI
Insertion using water exchange, withdrawal using air insufflation.

Locations

Country	Name	City	State
Czech Republic	Digestive Diseases Center, Vìtkovice Hospital	Ostrava
Italy	Digestive Endoscopy Unit, Ospedale S. Barbara	Iglesias	CI
United States	Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Presidio Ospedaliero Santa Barbara

Countries where clinical trial is conducted

United States,  Czech Republic,  Italy, 

References & Publications (5)

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 — View Citation

Falt P, Liberda M, Smajstrla V, Kliment M, Bártková A, Tvrdík J, Fojtík P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepato — View 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. — View 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 availab — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cecal intubation rate.	Cecal intubation will be defined as reaching beyond the ileocecal valve with adequate visualization of the appendix orifice.	1 hour.	No
Other	Cecal intubation time.	Defined as the time for passage of the colonoscope from the rectum to the cecum.	1 hour.	No
Other	Total procedure time.	Total procedure time (including time required for water infusion, polyp resection or biopsy).	1 hour.	No
Other	Adenoma detection rate.	Proportion of subjects with at least one adenoma of any size.	9 months.	No
Other	On-demand sedation.	Offered at patient request for a NRS score =2. Medications given as per institutional regulation. Dose titrated based on patients' reported real-time pain score, age, weight and comorbidity.	1 hour.	No
Other	Oxygen desaturation.	Significant oxygen desaturation (<85% for >15 seconds) will be recorded.	1 hour.	Yes
Other	Vagal reaction.	Vagal reaction (heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.	1 hour.	Yes
Primary	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.	Within the first 24 hours after the procedure.	No
Secondary	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.	Within the first 24 hours after the procedure.	No
Secondary	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.	1 hour.	No
Secondary	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.	6 hours.	No
Secondary	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.	24 hours.	No
Secondary	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.	6 hours.	No
Secondary	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.	6 hours.	No
Secondary	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.	24 hours.	No
Secondary	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.	24 hours.	No
Secondary	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.	Up to 12 hours.	No
Secondary	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.	24 hours.	No

External Links

•   Cadoni S, Falt P, Leung F.W. Clinical evidence in support of use of carbon dioxide insufflation in colonoscopy: a narrative review. J interv Gastroenterol 5:1, 20-24; January/February/March 2015.