RCT of Air Insufflation Versus Water Infusion Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.

Detailed Description
-----------------
Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy. Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients. Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy. Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request. Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy. Limitations: Single VA site, older male population

Official Title
-----------------
A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: water infusion colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individual 50 years or older eligible for colorectal cancer screening or surveillance Exclusion Criteria: patients who do not understand or failed to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: water infusion colonoscopy|water infusion in lieu of air insufflation for screening colonoscopy|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increments of medications used for sedation |  | duration of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores during colonoscopy |  | duration of procedure | 
| success with cecal intubation |  | during procedure | 
| willingness to repeat colonoscopy |  | after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer screening, optical colonoscopy, water method, sedation