Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954862
• Other study ID #: PG. 2013/3403
• Status: Completed
• Phase: N/A
• First received: September 27, 2013
• Last updated: July 30, 2014
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Presidio Ospedaliero Santa Barbara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenomas
• Colorectal Cancer
• Pain

Intervention

Other:
• Air Insufflation method.
Air Insufflation method.
• CO2 insufflation
CO2 insufflation.
• Water Immersion/CO2
Water Immersion during insertion, CO2 insufflation during withdrawal.
• Water Exchange/CO2
Water Exchange during insertion, CO2 insufflation during withdrawal.
• Water Immersion/AI
Water Immersion during insertion, AI insufflation during withdrawal.
• Water Exchange/AI
Water Exchange during insertion, AI insufflation during withdrawal.

Locations

Country	Name	City	State
Czech Republic	Vìtkovice Hospital	Ostrava
Italy	S. Barbara Hospital	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 (7)

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. — View 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. Review. — 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 Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16. — View 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. Review. — View Citation

Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Position changes.	Change in patient position as needed if advancement of the colonoscope fails.	1 hour.	No
Other	Loop reduction maneuvers.	Applied as needed if advancement of the colonoscope fails.	1 hour.	No
Other	Amount of water used during the procedure.	Amount of water infused and aspirated during insertion and withdrawal.	1 hour.	No
Other	Bloating at completion of examination.	Bloating felt by patients at completion of examination on a 10 point visual analogue scale.	1 hour.	No
Other	Bloating at discharge.	Bloating felt by patients at discharge measured on a ten point visual analogue scale.	1 hour.	No
Other	Patients willingness to repeat the examination.	Patients willingness to repeat the examination based on overall satisfaction about procedure. Measured at discharge on a yes/no question.	1 hour.	No
Other	Oxygen desaturation.	Significant oxygen desaturation will be recorded when values less than 85% will be maintained for more than 15 seconds.	1 hour.	Yes
Other	Vagal reaction.	Vagal reaction is defined as heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting.	1 hour.	Yes
Other	Abdominal Compression.	Compression of abdomen if advancement of the colonoscope fails.	1 hour.	No
Primary	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.	1 hour	No
Secondary	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.	1 hour.	No
Secondary	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.	1 hour	No
Secondary	Cecal intubation time.	Cecal intubation time will be defined as the time for passage of the colonoscope from the rectum to the cecum.	1 hour.	No
Secondary	Total procedure time.	Total procedure time (including time required for polyp resection or biopsy).	1 hour.	No
Secondary	Adenoma detection rate.	Proportion of subjects with at least one adenoma of any size.	15 months.	No
Secondary	Mean adenomas per procedure.	Total number of adenomas resected per subject.	15 months.	No
Secondary	Advanced adenomas.	Total number of advanced adenomas: diameter =10mm, or high grade dysplasia, or with =20% villous components.	15 months.	No