Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

Dalin Tzu Chi General Hospital

Status: Completed

Conditions: Colon Neoplasm; Pain

Treatments: Procedure: air insufflation; Procedure: water exchange; Procedure: water immersion

Study type: Interventional

Funder types: Other

Identifiers

NCT01535326

DalinTCGH-hsieh-01

Details and patient eligibility

About

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.

Full description

All procedures will be recorded and stored as digital files.

Enrollment: 270 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 3 patient groups, including a placebo group

air insufflation

Placebo Comparator group

Description:

Use air insufflation during colonoscopy

Treatment:

Procedure: air insufflation

water immersion

Active Comparator group

Description:

infuse water during insertion, remove water during withdrawal of colonoscopy

Treatment:

Procedure: water immersion

water exchange

Active Comparator group

Description:

infuse and remove water during insertion phase of colonoscopy

Treatment:

Procedure: water exchange