Warm Water for Unsedated Colonoscopy (WW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vittorio Terruzzi, Valduce Hospital
ClinicalTrials.gov Identifier:
NCT00905554
First received: May 15, 2009
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.


Condition Intervention
Colonoscopy
Procedure: warm water irrigation
Procedure: air insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Valduce Hospital:

Primary Outcome Measures:
  • Number of Patients Undergoing Complete Unsedated Colonoscopy [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of Pain and Tolerability Scores [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
    Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)


Enrollment: 230
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: warm water
warm water irrigation during the insertion phase of colonoscopy
Procedure: warm water irrigation
warm water irrigation during insertion phase of colonoscopy
Active Comparator: air
air insufflation during the insertion phase of colonoscopy
Procedure: air insufflation
air insufflation during the insertion phase of colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

  • refuse to initiate colonoscopy without routine sedation
  • inadequate bowel preparation
  • incapacity to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905554

Locations
Italy
Valduce Hospital
Como, CO, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
  More Information

No publications provided by Valduce Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vittorio Terruzzi, MD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT00905554     History of Changes
Other Study ID Numbers: WW01
Study First Received: May 15, 2009
Results First Received: August 5, 2011
Last Updated: September 15, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Valduce Hospital:
sedation
warm water

ClinicalTrials.gov processed this record on July 23, 2014