Objective of this quasi-experimental study: Evaluation the effect of early removal (on the first day after surgery) of urinary catheter, on the rate of urinary complications in patients who undergone rectal cancer surgery.
Design of study:
Inclusion criteria: Candidate for rectal cancer surgery; Both male and female;
Exclusion criteria: Previous history of urinary infectious; Previous history of urinary retention and incontinence;
Sample size: 80 patients.
Blinding and randomization: Not conducted.
Center: Single center (Imam Hossein hospital).
Intervention: Removal of urinary catheter on post-operative day.
Main outcomes: Urinary complications such as retention and urinary incontinence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072635290N1
Registration date:2017-08-18, 1396/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-18, 1396/05/27
Registrant information
Name
Bita Eslami
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1571
Email address
b-eslami@alumni.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of early removal of urinary catheter after rectal cancer surgery in urinary problems incidence
Public title
Early removal of urinary catheter in patients who undergone cancer surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for rectal cancer surgery; Both male and female;
Exclusion criteria: Previous history of urinary infectious; Previous history of urinary retention and incontinence;
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Quasi-experimental study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
3rd floor, Medical School, Next to Taleghani hospital, Chamran Highway
City
Tehran
Postal code
1985717434
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.SBMU.MSP.REC.1395.599
Health conditions studied
1
Description of health condition studied
Urinary retention
ICD-10 code
N39.9
ICD-10 code description
Disorder of urinary system, unspecified
2
Description of health condition studied
Rectal cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
3
Description of health condition studied
Urinary incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Urinary complications
Timepoint
Every day untill discharge from hospital
Method of measurement
Evaluation by physician
Secondary outcomes
empty
Intervention groups
1
Description
Removal of urinary catheter on post-operative day
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Amirmohsen Jalaeefar
Street address
Imam Hossein hospital, Shahid Madani St., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Science
Full name of responsible person
Mrs. Poorali
Street address
3rd floor, Medical school, Next to Taleghani hospital, Evin, Chamran highway.
City
Tehran
Grant name
Grant code / Reference number
1395.599
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Science
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Amirmohsen Jalaeefar
Position
Assistant Professor
Other areas of specialty/work
Street address
Institute of cancer, Imam Khomeini hospital, Dr Gharib St., Keshavarz Blv.
City
Tehran
Postal code
1419733141
Phone
+98 21 2249 8272
Fax
+98 21 6658 1526
Email
amjalaeefar@sina.tums.ac.ir; jalaeefar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Amirmohsen Jalaeefar
Position
Assistant Professor
Other areas of specialty/work
Street address
Institute of cancer, Imam Khomeini hospital, Dr Gharib St., Keshavarz Blv.
City
Tehran
Postal code
1419733141
Phone
+98 21 2249 8272
Fax
+98 21 6658 1526
Email
amjalaeefar@sina.tums.ac.ir; jalaeefar@gamil.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Bita Eslami
Position
PhD
Other areas of specialty/work
Street address
Institute of cancer, Imam Khomeini hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6658 1571
Fax
+98 21 6658 1526
Email
bita_i2001@yahoo.com; b-eslami@alumni.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)