Comparative study on the effect of brushing with traditional wooden toothbrush and drinking coffee on the duration of postoperative ileus and duration of hospitalization in patients undergoing elective gastrointestinal surgery
The effect of brushing with a wooden toothbrush and coffee on the duration of ileus after gastrointestinal surgery
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, Excel software rand function was used for randomization.
Settings and conduct
Patients will be divided into three groups of wooden toothbrush, coffee and control by permutation blocks with a size of 6 by 11 blocks. Patients will undergo elective gastrointestinal surgery after providing information and obtaining informed consent. In all three groups of patients, according to the clinical condition of each patient, standard postoperative ileus treatments will be performed. The wooden toothbrush group will use the traditional wooden toothbrush twice a day (morning and night) for 5 minutes from the morning after the operation. Patients in the coffee group will also receive 100 ml of bitter coffee 3 times a day (morning, noon and night) from the morning after surgery. The control and wooden toothbrush groups will drink 100 ml of water 3 times a day from the morning after the operation. Treatment is given to each patient until the end of the ileus symptoms. The researcher will be informed about the time of the first gas excretion and the time of the patient's first stool. The study is performed in Amin Hospital of Isfahan.
Participants/Inclusion and exclusion criteria
Admission requirements:
Patients undergoing elective gastrointestinal surgery.
Conditions for not entering the study:
History of underlying diseases and inflammatory bowel diseases and allergies to coffee.
Intervention groups
The study consists of three groups of 22 people and starts in the morning after surgery for one group of toothbrushes, for one group of coffee and for the control group the standard treatment of ileus.
Main outcome variables
Change in ileus duration, change in hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211025052864N1
Registration date:2021-11-21, 1400/08/30
Registration timing:registered_while_recruiting
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
Ebrahim Esfandiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9501
Email address
esfandiari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the effect of brushing with traditional wooden toothbrush and drinking coffee on the duration of postoperative ileus and duration of hospitalization in patients undergoing elective gastrointestinal surgery
Public title
Comparative effect of wooden toothbrush and coffee on ileus after surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elective gastrointestinal surgery
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization, permutation blocks
Patients will be divided into three groups of toothbrush stick, coffee and control by permutation blocks with a size of 6 by 11 blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Department of Anatomy, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-10-13, 1400/07/21
Ethics committee reference number
IR.MUI.MED.REC.1400.578
Health conditions studied
1
Description of health condition studied
Ileus
ICD-10 code
K56.7
ICD-10 code description
Ileus, unspecified
Primary outcomes
1
Description
The first time to expel gas or feces
Timepoint
No specific timing
Method of measurement
Patient report
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: wooden Toothbrush group: Patients will use traditional wooden toothbrush twice a day (morning and night) for 5 minutes from the morning after surgery. The required wooden toothbrush will all be provided from the same type.
Category
Other
2
Description
Intervention group: Coffee group: Patients will receive 100 ml of bitter coffee 3 times a day (morning, afternoon and evening) from the morning after surgery. Coffee is made using simple instant coffee powder and all patients will use the same brand and company of coffee unit.
Category
Other
3
Description
Control group: For this group, the usual standard ileus treatment is performed and they receive 100 cc of oral water 3 times a day.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Ebrahim esfandiari
Street address
Department of Anatomy, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 9105
Email
esfandiari@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim esfandiari
Street address
Department of Anatomy, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 9105
Email
esfandiari@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim esfandiari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Department of Anatomy, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 9105
Email
esfandiari@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim esfandiari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Department of Anatomy, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 9105
Email
esfandiari@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim esfandiari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Department of Anatomy, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
After printing the results
To whom data/document is available
Everyone
Under which criteria data/document could be used
To treat patients
From where data/document is obtainable
Dr. Ebrahim Esfandiari
Contact phone: 03137929105
Address: Isfahan, Hezar Jerib St., Isfahan University of Medical Sciences, School of Medicine, Department of Anatomy
Postal Code: 81746-73461
What processes are involved for a request to access data/document
Upon submission of the request from the project manager, the documents will reach him within a maximum of two days