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

Phase

N/A

Condition

Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT01954862

PG. 2013/3403

Ages 18-85
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Consecutive 18 to 85 year-old diagnostic in-patients and outpatients agreeing to startprocedure without premedication.

Exclusion

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

October 01, 2013

July 31, 2014

Study 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.

Connect with a study center

Vìtkovice Hospital
Ostrava, 703 84
Czech Republic
Site Not Available
S. Barbara Hospital
Iglesias, CI 09016
Italy
Site Not Available
Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
Los Angeles, California 91343
United States
Site Not Available

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