NCT01535326

Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Dalin Tzu Chi General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

All procedures will be recorded and stored as digital files.

Conditions

• Colon Neoplasm
• Pain

Interventions

Type	Name	Description
PROCEDURE	air insufflation	insufflate air during the insertion of colonoscopy
PROCEDURE	water immersion	infuse water during insertion, aspirate water during withdrawal
PROCEDURE	water exchange	infuse and remove water during insertion phase of colonoscopy

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-02-17
• Last updated: 2014-08-15
• Results posted: 2014-08-15

Locations

1 site across 1 country: Taiwan