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Completed

NCT Number: NCT01535326

Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

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.

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Key information

About this study

All procedures will be recorded and stored as digital files.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

air insufflation

Procedure

insufflate air during the insertion of colonoscopy

Water immersion

Procedure

infuse water during insertion, aspirate water during withdrawal

water exchange

Procedure

infuse and remove water during insertion phase of colonoscopy

Primary outcomes

  1. Proportion of Patients Without Pain

    Time frame: up to 12 months

    proportion of patients without insertion pain during colonoscopy

Secondary outcomes

  1. Patient Pain Score

    Time frame: 9 to 12 months

    The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)

  2. Patient Satisfaction Score

    Time frame: 9 to 12 months

    satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied

  3. Number of Participants With at Least One Adenoma

    Time frame: 9 to 12 months

    the number of participants with at least one adenoma in each of the study groups.

Other outcomes

  1. Post-procedure Discomforts and 30 Day Complication Rate

    Time frame: one month

    telephone follow up for post-procedure discomforts and 30 day complication rate

Sponsors and collaborators

Lead sponsor

Dalin Tzu Chi General Hospital

Other

Registry information

Official study title

Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 17, 2012
Registry last updated
Aug 15, 2014

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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