Clinical Trials Logo
  1. Home
  2. Colonoscopy
  3. NCT02759081
  4. Details
NCT02759081 Clinical Trial

Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

Colonoscopy Clinical Trial

Official title:
A Randomized, Controlled Trial Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02759081
Other study ID # Hsieh-2016-01
Secondary ID
Status Completed
Phase N/A
First received April 5, 2016
Last updated April 29, 2016
Start date January 2015

Study information
Verified date April 2016
Source Dalin Tzu Chi General Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients undergoing fully sedated colonoscopy performed by the investigators

Exclusion Criteria:

- obstructive lesions of the colon

- massive ascites

- history of partial colectomy

- provide written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• cap-assisted water exchange
a transparent cap was mounted to the tip of colonoscopy when water exchange was performed.
Procedure:
• water exchange
water was infused and suctioned at the same time during insertion of colonoscope

Locations
Country Name City State
Taiwan Dalin Tzu Chi General Hospital Chia-Yi

Sponsors (1)
Lead Sponsor Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Kondo S, Yamaji Y, Watabe H, Yamada A, Sugimoto T, Ohta M, Ogura K, Okamoto M, Yoshida H, Kawabe T, Omata M. A randomized controlled trial evaluating the usefulness of a transparent hood attached to the tip of the colonoscope. Am J Gastroenterol. 2007 Jan;102(1):75-81. Epub 2006 Nov 13. — View Citation

Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56. — View Citation

Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467. Review. — View Citation

Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary cecal intubation time when the colonoscope reaches the cecum, an average of 14 minutes No
Secondary Dose of propofol The end of colonoscopy, an average of 14 minutes No
Secondary adenoma detection rate when histology analysis of the removed polyps are available One week after colonoscopy No
See also
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT03247595 - Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy N/A
Completed NCT04214301 - An Open-Label Preference Evaluation of BLI800 Phase 4
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Recruiting NCT02484105 - Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction Phase 4
Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
Terminated NCT01978509 - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies N/A
Recruiting NCT01685970 - Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy Phase 3
Completed NCT01518790 - Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children N/A
Recruiting NCT00748293 - Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet N/A
Completed NCT00779649 - MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial Phase 4
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT00380497 - Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children Phase 4
Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A