A Double-blind randomised controlled trial to compare buscopan versus placebo as an adjunct to colonoscopy

• Conditions: pathology of the large bowel as detected by colonoscopy

• Registration Number: EUCTR2004-002966-39-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

all patients due to undergo colonoscopy at the Northern General Hospital in Sheffield will be invited to take part in this study. This will include patients requesting Midazolam (intravenous sedation) or Entonox (inhaled analgesia) during their colonoscopy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

allergy to buscopan; previous bowel resection; glaucoma; obstructive uropathy; autonomic dysfunction; myasthenia gravis; concurrent anticholinergic medication;l inability to consent or understand or read English.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): the primary endpoints are:<br>1) spasm - does buscopan decrease spasms of the bowel?<br>2) mucosal visualisation - does buscopan allow for greater visualisation of pathologies of the large bowel? ;Main Objective: the principle research questions are:<br>1) does the routine use of buscopan decrease bowel spasm?<br>2) does the routine use of buscopan improve mucosal visualisation and therefore, the detection of pathology (i.e. polyps, cancers, flat adenomas, vascular lesion). ;Secondary Objective: the secondary research questions are: <br>1) does the routine use of buscopan ease and speed the insertion and withdrawel of the endoscope?<br>2) does the routine use of buscopan during colonoscopy influence patients discomfort during the procedure<br>3) does the routine ise of buscopan during colonoscopy cause adverse effects?