Clinical trial NCT01954862: Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Presidio Ospedaliero Santa Barbara
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Consecutive 18 to 85 year-old diagnostic in-patients and 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 assumption of bowel preparation
* moderate or severe chronic obstructive pulmonary disease requiring oxygen
* medical history of CO2 retention

Primary outcomes:
measure: Maximum pain score recorded during colonoscopy.
timeFrame: 1 hour
Secondary outcomes:
measure: Overall pain after the procedure.
timeFrame: 1 hour.
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: 15 months.
measure: Mean adenomas per procedure.
timeFrame: 15 months.
measure: Advanced adenomas.
timeFrame: 15 months.
Other outcomes:
measure: Position changes.
timeFrame: 1 hour.
measure: Loop reduction maneuvers.
timeFrame: 1 hour.
measure: Amount of water used during the procedure.
timeFrame: 1 hour.
measure: Bloating at completion of examination.
timeFrame: 1 hour.
measure: Bloating at discharge.
timeFrame: 1 hour.
measure: Patients willingness to repeat the examination.
timeFrame: 1 hour.
measure: Oxygen desaturation.
timeFrame: 1 hour.
measure: Vagal reaction.
timeFrame: 1 hour.
measure: Abdominal Compression.
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: Vìtkovice Hospital
city: Iglesias
country: Italy
facility: S. Barbara Hospital
state: CI
Study officials:
affiliation: S. Barbara Hospital, Iglesias (CI), Italy
name: Sergio Cadoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Amato 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.
citation: Leung 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.
citation: Rabenstein 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.
citation: Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.
citation: Wu 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.
citation: Dellon 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.
citation: Cadoni 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.