A Comparison of Air Insufflation, Water Immersion and Water Exchange Colonoscopy in Diagnostic Patients

Summary

Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water Immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.

Conditions

• Pain
• Colorectal Adenomas
• Colorectal Cancer

Interventions

OTHER

Air Insufflation method.

Colonoscopy will be performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure.

OTHER

Water Immersion method.

Air will not be insufflated until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if \>3) if the lumen cannot be seen. Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal.

OTHER

Water Exchange method.

Air will not be insufflated until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Suction of water will also be applied when colonoscope insertion proceeds smoothly. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned.

Sponsors & Collaborators

• Presidio Ospedaliero Santa Barbara

  lead OTHER

Principal Investigators

• Sergio Cadoni, MD · S. Barbara Hospital, Iglesias (CA), Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2013-09-30

Completion

2013-09-30

Countries

• United States
• Italy

Study Locations