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A Comparative study on Effect of two Types of Urine drainage cares (Open/closed system) on acute complications after Hypospadias repair in 6-36 months old children

Protocol summary

Summary
This randomized, single-blind, single-center clinical trial has been conducted on children admitted to surgical clinic at Mofid children's hospital over the year 2011-2012 in order to compare the effectiveness of two urine drainage care methods ( open/close ) on acute complications of Hypospadias repair and the study was continued for 15 months. The age between 6-36 months and being diagnosed with mid-shaft and distal Hypospadias and Underwent the TIP procedure (Tubularized Incised Plate Urethroplasty) were among inclusion criteria and kidney disease, diabetes mellitus, coagulation defects and immune deficiency, have been considered as exclusion criteria. 108 children in confirmation with inclusion criteria have been randomly split in 2 groups of 54. Groups were tried to be similar in terms of severity of abnormality, surgical history and chordee condition. The studied intervention method were open urine drainage care (double-nappy care method). In control group urine discharged by open method using urine bag. Urine volume over 24h, patency of the new urethra, bleeding and edema in surgical site, urinary tract infection, wound infection, wound dehiscence, removal of catheter by patient, level of child restlessness determined by amount of analgesics received as the primary outcome measure were all observed and measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014010816142N1
Registration date: 2014-02-03, 1392/11/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-03, 1392/11/14
Registrant information
Name
Marzieh Fatemian
Name of organization / entity
Shaheed Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8840 7109
Email address
fatemian.marzieh@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2010-12-26, 1389/10/05
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study on Effect of two Types of Urine drainage cares (Open/closed system) on acute complications after Hypospadias repair in 6-36 months old children
Public title
The effect of double nappy technique on acute complications of urethroplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Criteria for inclusion: Being diagnosed with mid-shaft and distal hypospadias; Age between 6-36 months; Underwent the TIP procedure (Tubularized Incised Plate Urethroplasty); Parental consent Criteria for exclusion: Age below 6 month or older than 36 month; other than TIP procedure; Being diagnosed with hypospadias other than mid-shaft and distal; Accompanied by other diseases (Kidney disease, Diabetes Mellitus, coagulation defects, immune deficiency); Parents did not consent
Age
To 3 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 108
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
Vice chancellor for Research Shahid Beheshti University of Medical sciences
Street address
Chamran Highway - Evin
City
Tehran
Postal code
Approval date
2010-10-31, 1389/08/09
Ethics committee reference number
89-01-119-7088

Health conditions studied

1

Description of health condition studied
Hypospadias
ICD-10 code
Q54.1
ICD-10 code description
Hypospadias, penile

Primary outcomes

1

Description
removal of catheter by patient
Timepoint
every 3h for 7 days
Method of measurement
observations are recorded in patient’s information sheet

2

Description
level of child restlessness
Timepoint
every 3h for 7 days
Method of measurement
determined by amount of analgesics received and recorded patient’s information sheet

3

Description
Catheter irrigation if needed
Timepoint
if needed
Method of measurement
observed and recorded in patient’s information sheet

4

Description
patency of the new urethra
Timepoint
every 3h for 7 days
Method of measurement
observations are recorded in patient’s information sheet

5

Description
Urine volume over 24h
Timepoint
every 3h for 7 days
Method of measurement
observations are recorded in patient’s information sheet

6

Description
urinary tract infection
Timepoint
befor surgery and after removal of catheter
Method of measurement
urine calture and recorded in patient’s information sheet

7

Description
wound dehiscence
Timepoint
daily for 7 days
Method of measurement
observed and recorded in patient’s information sheet

8

Description
edima and bleeding in surgical site
Timepoint
every 3h for 7 days
Method of measurement
observed and recorded in patient’s information sheet

9

Description
wound infection in surgical site
Timepoint
daily for 7 days
Method of measurement
observed and recorded in patient’s information sheet

Secondary outcomes

1

Description
strictures
Timepoint
at the time of catheter removal, one month, three month, six month after surgery
Method of measurement
observations are recorded in patient’s information sheet

2

Description
fistulas
Timepoint
at the time of catheter removal one month, three month, six month after surgery
Method of measurement
observations are recorded in patient’s information sheet

Intervention groups

1

Description
Intervention group with open urine drainage care (double nappy care method) after-surgery, the following procedure has been used: 1-In the central area of the first diaper a 3 by 3 cm two intersecting lines has been marked and cut. With a scissor two diagonal lines will be cut providing 4 triangles 2- 8 adhesive tapes (8cm in length by 1.5 cm in width) are needed 3- Fold one of the triangles inwardly and fix it with tape 4- The same procedure should be applied to the rest of three triangles. Cover lines between triangle with tape In order to avoid any contact with surgical site . 5- Lubricate around the hole in order to minimize the contact with surgical area. 6- Diapering should be done in such a way that the hole be in the front. 7-The tip of the stent carefully passes through the hole in the nappy. 8-First diaper should be fixed on child body by applying tapes. 9-Then, the second diaper with a larger size has been used. The free end of stent catheter has been positioned carefully and kinking, twisting or blocking were extremely avoided. 10- The inner diaper should be changed right after each defecation. The outer one should be changed upon contamination or wetting. There was no need to restrict child's movement and mother could hang the child. Mother learned how to change and weight the diaper. Evaluation indicators should be recorded after surgery through accurate observations.for 7 days and each 3 hrs (the dried diapers were weighted and again after getting wet and urine output measured and recorded).
Category
Prevention

2

Description
Control group, with close urine drainage care after surgery the following procedure has been used : the dripping stent has been attached to a urine bag and it was fixed by hanger bar on railing's bed. The stent catheter was fixed on lower abdomen by adhesive tape . It should be noted that kinking, twisting or blocking of the dripping stent must be avoided. The child was place on the bed cradle and immobilized with arm or leg joints restraints . Mother learned how to care the catheter . Evaluation indicators should be recorded after surgery through accurate observations.for 7 days and each 3 hrs .
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid Children's Hospital
Full name of responsible person
Marzieh Fatemian (BS in nursing)
Street address
Mofid Children's Hospital , Mirdamad ST, Shariati AVe
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research Shahid Beheshti University Medical Scieneces
Full name of responsible person
Marzieh Fatemian (BS in nursing)
Street address
Mofid Children's Hospital, Mirdamad ST, Shariati AVe
City
Tehran
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 Shahid Beheshti University Medical Scieneces
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
shahid Beheshti University of Medical Sciences
Full name of responsible person
Marzieh Fatemian
Position
BS in nursing / Headnurse
Other areas of specialty/work
Street address
Mofid Chidlren's Hospital , Mirdamad ST, Shariati AVe
City
Tehran
Postal code
Phone
+98 21 2290 9575
Fax
+98 21 2290 4538
Email
fatemian.marzieh@gmail.com fatemian_marzieh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Fatemeh Alaee karahroudy
Position
Phd student in nursing Welfare and Rehabilitation Sciences University ms in pediatric nursing educat
Other areas of specialty/work
Street address
Faculty in Nursing and Midwifery , Niyayesh Highway , Valiasr Ave
City
Tehran
Postal code
Phone
+98 21 8865 5372
Fax
Email
fatemeha@sbmu.ac.irfalaee@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Fatemeh Alaee Karahroudy
Position
Phd student in nursing Welfare and Rehabilitation Sciences University ms in pediatric nursing educat
Other areas of specialty/work
Street address
Faculty in Nursing and Midwifery , Niyayesh Highway , Valiasr Ave
City
Tehran
Postal code
Phone
+98 21 8865 5372
Fax
Email
fatemeha@sbmu.ac.irfalaee@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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