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

Vitkovice Hospital420 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

420

Conditions

Colonoscopy

Interventions

Water immersion insertion AND CO2 insufflationPROCEDURE

* 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

Water immersion insertionPROCEDURE

* 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

CO2 insufflationPROCEDURE

\- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Digestive Diseases Center - Vitkovice Hospital

Ostrava, Czechia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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

Time frame: six months

Data from ClinicalTrials.gov

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