Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01535326
First received: February 11, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).

This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of Patients Without Pain [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    proportion of patients without insertion pain during colonoscopy


Secondary Outcome Measures:
  • Patient Pain Score [ Time Frame: 9 to 12 months ] [ Designated as safety issue: No ]
    The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)

  • Patient Satisfaction Score [ Time Frame: 9 to 12 months ] [ Designated as safety issue: No ]
    satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied

  • Number of Participants With at Least One Adenoma [ Time Frame: 9 to 12 months ] [ Designated as safety issue: No ]
    the number of participants with at least one adenoma in each of the study groups.


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


Enrollment: 270
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: air insufflation
Use air insufflation during colonoscopy
Procedure: air insufflation
insufflate air during the insertion of colonoscopy
Active Comparator: water immersion
infuse water during insertion, remove water during withdrawal of colonoscopy
Procedure: water immersion
infuse water during insertion, aspirate water during withdrawal
Active Comparator: water exchange
infuse and remove water during insertion phase of colonoscopy
Procedure: water exchange
infuse and remove water during insertion phase of colonoscopy

Detailed Description:

All procedures 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 minimally sedated colonoscopy

Exclusion Criteria:

  • Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, 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: NCT01535326

Locations
Taiwan
Dalin Tzu Chi General Hospital
Chia-Yi, Taiwan, 622
Dalin Tzu Chi General Hospital
Chiayi, Taiwan, 622
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
Principal Investigator: Yu-Hsi Hsieh, Dr. 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: NCT01535326     History of Changes
Other Study ID Numbers: DalinTCGH-hsieh-01
Study First Received: February 11, 2012
Results First Received: March 16, 2014
Last Updated: July 28, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Dalin Tzu Chi General Hospital:
colonoscopy

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

ClinicalTrials.gov processed this record on October 21, 2014