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Completed

NCT Number: NCT01440543

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

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).

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Digestive Diseases Center - Vitkovice Hospital

Ostrava, 703 84, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water immersion insertion AND CO2 insufflation

Procedure
  • 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 insertion

Procedure
  • 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 insufflation

Procedure
  • CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal

Primary outcomes

  1. Success Rate of Minimal Sedation Colonoscopy

    Time frame: six months

    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.

  2. Success Rate of Minimal Sedation Colonoscopy

    Time frame: 6 months

    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.

Secondary outcomes

  1. Patient Comfort During the Procedure and During First 24 Hours After Procedure

    Time frame: six months

    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

Sponsors and collaborators

Lead sponsor

Vitkovice Hospital

Other

Registry information

Official study title

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

Acronym: Water/CO2

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 26, 2011
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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