Comparison of effect of urinary catheterization in morbid obese patients are undergone bariatric laparoscopic surgery versus patient without catheterization on urinary complication of surgery
This is an interventional study to compare urinary catheterization in patients undergone bariatric laparoscopic surgery versus patient without catheterization and assess the urinary complications after surgery in this 2 groups of morbid obese patients .
The study includes morbid obese patients undergone bariatric laparoscopic surgery and the patients with urinary disorder and who needs to ICU care before or after surgery are excluded . also the study doesn’t include patients if the surgery convert to open or takes more than 4 hours. the population of study are patients with morbid obesity who randomly are divided in two groups of 40 patients.
For case group, urinary catheterization during surgery isn’t done and if the surgery of these patients take more than two hours, after surgery, urinary bladder will be empty by temporary catheter. in the control group, preoperative urinary catheterization is done and 24 hours after surgery it will be removed. in both groups after surgery, on day of surgery , first and second day after surgery ,the urine volume, urinary infection , retention , urinary incontinence the level of Satisfaction of catheterization and the probably problems with urinary tract are valued by asking , patient examination and lab test if needed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206108588N7
Registration date:2012-08-07, 1391/05/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-07, 1391/05/17
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2012-06-01, 1391/03/12
Expected recruitment end date
2013-11-30, 1392/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of urinary catheterization in morbid obese patients are undergone bariatric laparoscopic surgery versus patient without catheterization on urinary complication of surgery
Public title
Comparison of complications in Morbid obese patients undergone bariatric laparoscopic surgery with and without urinary catheterization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients with BMI >35 with comorbidities or BMI>40 who candidate for bariatric laparoscopic surgery.
Exclusion criteria: the patients with urinary disorder; the patients who needs to ICU care before or after surgery; patients who their surgery is converted to open; the patients who are undergone surgery more than 4 hours.
Age
From 16 years old to 64 years old
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences.
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-06-24, 1391/04/04
Ethics committee reference number
17551
Health conditions studied
1
Description of health condition studied
urinary Catheterization
ICD-10 code
Y84.6
ICD-10 code description
Urinary catheterization
2
Description of health condition studied
urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
3
Description of health condition studied
urinary retention
ICD-10 code
R33
ICD-10 code description
Retention of urine
Primary outcomes
1
Description
Urinary Tract Infection
Timepoint
after Intervention,one day after intervention, Two days after intervention
Method of measurement
Urine culture
2
Description
urinary Incontinency
Timepoint
after Intervention,one day after intervention, two days after intervention
Method of measurement
The patient complained
Secondary outcomes
1
Description
Foreign body sensation
Timepoint
after intervention,one day after intervention,two day after intervention
Method of measurement
Question
Intervention groups
1
Description
For intervention group, urinary catheterization during surgery isn’t done and if the surgery of these patients take more than two hours, after surgery, urinary bladder will be empty by temporary catheter.
Category
Other
2
Description
in the control group, preoperative urinary catheterization is done and 24 hours after surgrey it will be removed.