Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Dalin Tzu Chi General Hospital
Sponsor:
Information provided by (Responsible Party):
Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01699399
First received: September 30, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

This prospective, randomized controlled trial compares traditional air insufflation with water immersion and water exchange in patients undergoing colonoscopy using on demand sedation. We test the hypothesis that compared with air insufflation the proportion of patients who require on demand sedation during colonoscopy will be significantly lowered by water immersion and water exchange, and water exchange will produce the greatest reduction


Condition Intervention
Colon Neoplasm
Procedure: water immersion
Procedure: water exchange
Procedure: air insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized, Controlled Trial Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation

Resource links provided by NLM:


Further study details as provided by Dalin Tzu Chi General Hospital:

Primary Outcome Measures:
  • Proportions of patients requiring sedation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • patient pain during insertion [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • post-procedure discomforts and 30 days complication rate [ Time Frame: one month ] [ Designated as safety issue: No ]
    telephone follow up for post-procedure discomforts and 30 days complication rate


Estimated Enrollment: 225
Study Start Date: August 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: water immersion
infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase.
Procedure: water immersion
Experimental: water exchange
infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase
Procedure: water exchange
Active Comparator: air insufflation
standard colonoscopy using traditional air insufflation during insertion
Procedure: air insufflation

Detailed Description:

The patients will be allocated into 3 groups by computerized randomization. In group A (water exchange), water will be infused and removed at the same time throughout the entire colon during the insertion phase with the air pump turned off. In group B (water immersion), water will be infused in the insertion phase and removed in the withdrawal phase. The water will be used mainly to open the lumen, without attempting to clear the colon contents. In group A and B, warm-to-touch water will be infused mainly infused through the accessory channel of the colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air insufflation not used until the cecum has been reached. . In group C, air insufflation will be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal compression and change of patient position will be utilized at the discretion of the colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be undertaken during the withdrawal phase.

During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none, 10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort. For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter, the nurse will offer sedation, which the patients can accept or decline. If accepted, after an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan, Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an adequate level of sedation. The need of additional drug will be estimated by patient pain response (moans, grimaces and movements). Usually no more propofol will be added during the withdrawal phase. The initial amount of propofol, and those before and after arrival to the cecum will be recorded.

The following parameters will be evaluated and recorded on the patient data sheet: quality of bowel preparation, cecal intubation time, withdrawal time total procedure time, use of abdominal pressure, need for changing position, presence of polyps and reasons for incomplete colonoscopy.

The procedure will be recorded and stored as digital files.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing colonoscopy performed by the endoscopist at our endoscopic suite

Exclusion Criteria:

  • request for sedation, indicated for bidirectional endoscopy, obstructive lesions of the colon, allergy to meperidine or propofol, American Society of Anesthesiology (ASA) risk Class 3 or higher, massive ascites, past history of partial colectomy, or refusal to provide written 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: NCT01699399

Locations
Taiwan
Dalin Tzu Chi General Hospital Recruiting
Chia-Yi, Taiwan, 622
Contact: Yu-Hsi Hsieh       hsieh.yuhsi@msa.hinet.net   
Principal Investigator: Yu-Hsi Hsieh, Dr.         
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
Principal Investigator: Yu-Hsi Hsieh, M.D. Dalin Tzu Chi General Hospital
  More Information

Publications:
Responsible Party: Yu-Hsi hsieh, Chief of department of gastroenterology and hepatology, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01699399     History of Changes
Other Study ID Numbers: DTCRD101(2)-E-03
Study First Received: September 30, 2012
Last Updated: July 29, 2014
Health Authority: Taiwan: The institutional review board of Dalin Tzu Chi General Hospital

Keywords provided by Dalin Tzu Chi General Hospital:
colonoscopy
pain
sedation
water

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014