Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy

Study Overview
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Brief Summary
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Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure. This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).

Official Title
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Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Conditions
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Colonoscopy

Intervention / Treatment
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* Procedure: Water immersion insertion AND CO2 insufflation
* Procedure: Water immersion insertion
* Procedure: CO2 insufflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women older than 18 years referred for diagnostic outpatient colonoscopy provided written consent Exclusion Criteria: history of colorectal surgery known diagnosis of inflammatory bowel disease chronic benzodiazepine use refusal of minimal sedation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water/CO2<br>water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal | Procedure: Water immersion insertion AND CO2 insufflation<br>* room temperature water infused by water pump into the colon just to facilitate scope insertion CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection<br>|
| Experimental: Water/Air<br>Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal | Procedure: Water immersion insertion<br>* room temperature water infused by water pump into the colon just to facilitate scope insertion standard room air insufflation during colonoscope withdrawal and mucosal inspection<br>|
| Experimental: CO2/CO2<br>CO2 insufflation during both colonoscope insertion and withdrawal | Procedure: CO2 insufflation<br>* - CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal<br>|
| No Intervention: Air/Air<br>room air insufflation during both colonoscope insertion and withdrawal | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Minimal Sedation Colonoscopy | Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam. | six months | 
| Success Rate of Minimal Sedation Colonoscopy | A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comfort During the Procedure and During First 24 Hours After Procedure | Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, water immersion, CO2 insufflation, patients referred for diagnostic outpatient colonoscopy, (screening, surveillance, symptoms), patient discomfort associated with diagnostic colonoscopy