The main problem in colonoscopy for endoscopists to advance the colonoscope and visualize the mucosa is colonic spasm. The aim of this study was to evaluate the efficacy of Colpermin as an orally administered antispasmodic premedication to reduce colon spasm and pain and increase satisfaction in a randomized double blinded placebo controlled trial.
Patients on whom total colonoscopy was not possible (due to obstruction by tumor or being high risk for perforation as in severe colitis or history of colectomy), pregnant and lactating women, and peppermint allergy history were excluded from the study.
Patients were randomly allocated by opening a sealed envelope with a computer-generated code in groups to recived either colpermin or placebo. The placebos were prepared in capsules with similar appearance to Colpermin which were filled with lactulose. Capsules were administered 4 hours before colonoscopy. Time required for intubation to the cecum and the total procedure time recorded by the endoscopist. After the colonoscopy, patients were asked to rate their pain by using a numerical rating scale. colonoscopist satisfaction and colon spasm score were assessed by the endoscopist immediately after the procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107056957N1
Registration date:2011-07-16, 1390/04/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-16, 1390/04/25
Registrant information
Name
Samaneh Khanpour Ardestani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 3060
Email address
khanpour@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2008-08-03, 1387/05/13
Expected recruitment end date
2009-08-04, 1388/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Premedication with Peppermint oil capsules (Colpermin®) in colonoscopy: A Double blind placebo-controlled randomized trial study
Public title
Colpermin in colonoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have indication for colonoscopy by expert physician; age more than 18 and signing the informed consent.
Exclusion criteria:
Patients that total colonoscopy is not possible for them (due to obstruction by tumor or being high risk for perforation as in severe colitis or history of colectomy); pregnant and lactating women, and peppermint allergy history
Age
From 18 years old to 81 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences Hezae jarib Street Isfahan
City
Isfahan
Postal code
Approval date
2007-05-27, 1386/03/06
Ethics committee reference number
286006
Health conditions studied
1
Description of health condition studied
patients with digestive diseases who need colonoscopy
ICD-10 code
k00-k93
ICD-10 code description
Crohn's disease [regional enteritis] , Ulcerative colitis , Other noninfective gastroenteritis and colitis, Vascular disorders of intestine , Diverticular disease of intestine , Other diseases of anus and rectum , Other diseases of digestive system
Primary outcomes
1
Description
pain
Timepoint
after colonoscopy
Method of measurement
numerical rating scale
2
Description
Time required for intubation to the cecum and the total procedure time
Timepoint
after colonoscopy
Method of measurement
minites
3
Description
colon spasm
Timepoint
after colonoscopy
Method of measurement
numerical rating scale for spasm
Secondary outcomes
1
Description
drug adverse effect
Timepoint
before and after colonoscopy
Method of measurement
questionnaire
2
Description
bowel preparation
Timepoint
after colonoscopy
Method of measurement
numerical rating scale for bowel preparation
3
Description
colonoscopist satisfaction
Timepoint
after colonoscopy
Method of measurement
numerical rating scale for colonoscopist satisfaction
4
Description
patient willingness to repeat colonoscopy with the present method
Timepoint
after colonoscopy
Method of measurement
questionnaire
Intervention groups
1
Description
Taking 2 colpermin (187 mg) capsules 4 hour before colonoscopy
Category
Treatment - Drugs
2
Description
Taking 2 placebo capsules (filling with lactulose) 4 hour before colonoscopy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Alzahra hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellory research Isfahan University of Medical Sciences
Full name of responsible person
Dr Peiman Adibi vice chancellor research of Isfahan University of Medical Sciences
Street address
Hezar jarib street Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellory research Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medi
Full name of responsible person
Dr Samaneh Khanpour Ardestani
Position
general practitioner
Other areas of specialty/work
Street address
Mahabad health center
City
Ardestan
Postal code
Phone
+98 31 1792 3060
Fax
Email
khanpour@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciensesl
Full name of responsible person
Dr Ahmad Shavakhi
Position
Digestive and liver sub specialist
Other areas of specialty/work
Street address
Isfahan University of Medical Scienses Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1792 3060
Fax
Email
shavakhi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Scienses
Full name of responsible person
Dr Samaneh Khanpour
Position
General practitioner
Other areas of specialty/work
Street address
City
Ardestan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)