Effect of the Routine Bowel Preparation versus Oral Sodium Phosphate Use on Patients’ Acceptance and Bowel Cleansing in Patients Undergoing Colonoscopy in Endoscopy Ward ( IRAN)
Abstract
Colonoscopy requires proper colon preparation that allows an effective procedure. There are different methods of bowel preparation available, with varying degrees of cleansing, effectiveness and patient acceptance. The aim of this study was to compare the effects of routine method (castor oil in addition to bisacodyl tablet) with oral sodium phosphate, on the level of patients’ acceptance and bowel cleansing .It was a randomized controlled trial with a sample size of 90 outpatient candidates for colonoscopy, randomly assigned to the control or experimental group. Data collection included a demographic questionnaire, assessment of patient satisfaction, and evaluation of bowel cleansing by the endoscopist. The findings revealed that oral sodium phosphate had higher patient acceptance (p < 0.001) and a better level of bowel preparation (p < 0.001). According to this result oral sodium phosphate has better acceptance and is more effective on colon cleansing, when compared with routine preparation.
Key word: colon disease / oral sodium phosphate / colonoscopy /Bowel preparation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902051174N5
Registration date:2010-05-20, 1389/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-20, 1389/02/30
Registrant information
Name
Atefeh Ghanbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13780509
Email address
at_ghanbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for research of Guilan University of Medical Sciences (GUMS)
Expected recruitment start date
2005-08-31, 1384/06/09
Expected recruitment end date
2005-11-30, 1384/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the Routine Bowel Preparation versus Oral Sodium Phosphate Use on Patients’ Acceptance and Bowel Cleansing in Patients Undergoing Colonoscopy in Endoscopy Ward ( IRAN)
Public title
Effect of the Routine Bowel Preparation versus Oral Sodium Phosphate Use on Patients’ Acceptance and Bowel Cleansing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for the study included: age over 18 years, no cerebrovascular disease or symptomatic ischemic heart disease in the past 6 months, no hepatic disease, creatinine (Cr) level could not be higher than 2mg/dL, absence of hypertension (diastolic blood pressure less than 100mmHg), no family history of insulin dependant diabetes mellitus (IDDM), subject could not be pregnant or postpartum (not lactating), no presence of stomach or intestinal obstruction, subject could not have taken iron derivatives in the previous 4 days, no ingestion of costive agents (codeine, lopramid) within last 12 hours and no history of using opium. Subjects were excluded from the study if they did not complete the bowel preparation or a total colonoscopy could not be performed
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences Ethics commitee
Street address
GUMS Guilan University of Medical Sciences
City
Rasht
Postal code
Approval date
2005-11-20, 1384/08/29
Ethics committee reference number
5720
Health conditions studied
1
Description of health condition studied
Gastrointestinal disorder
ICD-10 code
K00-K93
ICD-10 code description
Diseases of the digestive system
Primary outcomes
1
Description
Patients’ Acceptance
Timepoint
immediately following intervention
Method of measurement
checklist
Secondary outcomes
1
Description
Bowel cleansing
Timepoint
immediately following intervention
Method of measurement
checklist
Intervention groups
1
Description
Felete fosposoda
Category
Treatment - Drugs
2
Description
Castor oil
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastro intestinal center
Full name of responsible person
Dr Ghanaei
Street address
Razi Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research
Full name of responsible person
Dr Sobhani
Street address
Namjo st.,
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research
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
Guialn medical science university (nursing and midwifery )
Full name of responsible person
Dr Atefeh Ghanbari
Position
Assisstant Professor
Other areas of specialty/work
Street address
Guialn medical science university
City
Rasht
Postal code
Phone
+98 13 1322 2071
Fax
Email
at_ghanbari@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
GUMS
Full name of responsible person
Dr Ghanbari
Position
Assisstant Professor
Other areas of specialty/work
Street address
GUMS
City
Rasht
Postal code
Phone
+98 13 1322 2071
Fax
Email
at_ghanbari@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
GUMS
Full name of responsible person
Dr Ghanbari
Position
Assistant Professor
Other areas of specialty/work
Street address
GUMS
City
Rasht
Postal code
Phone
+98 13 1322 2071
Fax
Email
at_ghanbari@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)