Does the Hyoscine N-Butylbromide Administered During Colonoscopy Increase the Adenoma Detection Rate?

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at time of caecal intubation, increases the adenoma detection rate.

Detailed Description
-----------------
Outpatients referred for colonoscopy were screened for possible enrollment. Exclusion criteria included: glaucoma, benign prostatic hyperplasia or urinary obstruction, previous intestinal resection, ongoing therapy with tricyclic antidepressants, chronic renal failure and history of IBD. Eligible patients were randomized to receive either 20 mg/2ml of HBB i.v. or 2ml of saline i.v.; both the endoscopist and the patient were blind to the administered drug. The endoscopist was asked to inspect the right, transverse and left colon for at least 2 min for each segment. The number, size and location of polyps were recorded as well as the occurrence episodes of tachycardia (defined as bpm>140). As indirect estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC (difference in the abdominal circumference measured before and after colonoscopy) was also calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the patient was measured by means of a VA scale (range 0-100).

Official Title
-----------------
Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study

Conditions
-----------------
Colonic Adenomas

Intervention / Treatment
-----------------
* Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v.
* Drug: Saline 2 ml i.v.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: outpatients referred for colonoscopy Exclusion Criteria: glaucoma benign prostatic hyperplasia or urinary obstruction previous intestinal resection, ongoing therapy with tricyclic antidepressants chronic renal failure history of IBD participation other studies unsedated colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBB- Hioscine Butyl Bromide<br> | Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v.<br>* Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation<br>* Other names: Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.;|
| Placebo Comparator: Placebo arm<br> | Drug: Saline 2 ml i.v.<br>* Administration of Saline 2 ml at time of caecal intubation<br>* Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR) |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of HBB | As indirect estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC (difference in the abdominal circumference measured before and after colonoscopy) was also calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the patient was measured by means of a VA scale (range 0-100). | this outcome will be evaluated at the end of colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoma Detection Rate, Anti-spasmotic drug