Does the Hyoscine N-Butylbromide Administered During Colonoscopy Increase the Adenoma Detection Rate?
|ClinicalTrials.gov Identifier: NCT01609855|
Recruitment Status : Unknown
Verified May 2012 by Emanuele Rondonotti, Valduce Hospital.
Recruitment status was: Recruiting
First Posted : June 1, 2012
Last Update Posted : June 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colonic Adenomas||Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v. Drug: Saline 2 ml i.v.||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
|Experimental: HBB- Hioscine Butyl Bromide||
Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v.
Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation
Other Name: Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.
|Placebo Comparator: Placebo arm||
Drug: Saline 2 ml i.v.
Administration of Saline 2 ml at time of caecal intubation
Other Name: Saline
- Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR) [ Time Frame: 5 months ]
- Tolerability of HBB [ Time Frame: this outcome will be evaluated at the end of colonoscopy ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609855
|Contact: Emanuele Rondonotti, MDfirstname.lastname@example.org|
|Como, Italy, 20122|
|Sub-Investigator: Gianni Imperiali, MD|
|Principal Investigator: Vittorio Terruzzi, MD|
|Sub-Investigator: Giovanna Mandelli, MD|
|Sub-Investigator: Silvia Paggi, MD|
|Sub-Investigator: Nicoletta Lenoci, MD|
|Sub-Investigator: Arnaldo Amato, MD|
|Sub-Investigator: Natalia Terreni, MD|
|Como, Italy, 20122|
|Contact: Spinzi Giancarlo, MD 0039031324141 email@example.com|
|Study Director:||Spinzi Giancarlo, MD||Gastroenterology Unit, Ospedale Valduce, Como, Italy.|
|Study Chair:||Franco Radaelli, MD||Gastroenterology Unit, Ospedale Valduce, Como. Italy.|
|Principal Investigator:||Emanuele Rondonotti, MD||Gastroenterology Unit, Ospedale Valduvce, Como. Italy.|