Randomized
clinical trial to compare the outcomes of percutaneous technique and open
surgical peritoneal dialysis catheter placement in children with chronic renal failure
This research compared the outcomes of percutaneous technique and open surgical peritoneal dialysis catheter placement in children. This randomized controlled trial will perform in the department of pediatric nephrology and vascular surgery of Isfahan Alzahra university hospital. Informed consent will obtain from the parents of children taking part in our study. A total of 35 pediatric uremic patients will enroll and randomize into two study groups by random allocation software. Follow up data of this study include duration of operation (minute) ,duration of hospitalization (days) and onset time of peritoneal dialysis. Complications consider as mechanical and infectious.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091514670N1
Registration date:2013-09-23, 1392/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-23, 1392/07/01
Registrant information
Name
Sayed Mahdi Marashi
Name of organization / entity
Legal Medicine Organization
Country
Iran (Islamic Republic of)
Phone
+98 917 916 7438
Email address
marashi_m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-10, 1390/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized
clinical trial to compare the outcomes of percutaneous technique and open
surgical peritoneal dialysis catheter placement in children with chronic renal failure
Public title
Peritoneal dialysis catheter insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who will be receiving peritoneal dialysis and have family support.
Exclusion criteria: history of prior major abdominal surgery; ventral or inguinal hernia AND BMI
≥35 kg/m2.
Age
To 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
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
Isfahan University of Medical Sciences
Street address
Hezar Jarib St. Isfahan University of Medical Sciences, Deputy of Research
City
Isfahan
Postal code
81746-73461
Approval date
2009-07-27, 1388/05/05
Ethics committee reference number
288132
Health conditions studied
1
Description of health condition studied
Peritoneal dialysis catheter insertion
ICD-10 code
N 18.5
ICD-10 code description
End-stage kidney disease
Primary outcomes
1
Description
catheter outflow
Timepoint
weekly for 2 months
Method of measurement
sufficient catheter outflow
Secondary outcomes
1
Description
Hemoperitoneum
Timepoint
daily for 3 days
Method of measurement
reddish change in color of fluid
2
Description
exit site infection
Timepoint
days1,3,7,30,60
Method of measurement
examination
3
Description
peritonitis
Timepoint
daily for first 3days
Method of measurement
examination
Intervention groups
1
Description
Intervention group: percutaneous PDC; percutaneous method with secure insertion of thecatheter reduced the rate of some complications, although they were not statisticallysignificant but this technique reduces the time of hospitalization andoperation without need to general anesthesia. The onset of dialysis was earliersignificantly.
Category
Treatment - Surgery
2
Description
Cotrol group: conventional open surgical method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan alzahra hospital
Full name of responsible person
Hojatollah raji-general surgeon
Street address
Soffe blv. alzahra hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Hafez Ghaheri
Street address
Alzahra hospital
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Legal medicine research center
Full name of responsible person
Sayed Mahdi Marashi
Position
Forensic medicine specialist
Other areas of specialty/work
Street address
south side of City Park, Behesht Street,
City
Tehran
Postal code
1114795113
Phone
+98 21 5560 9071
Fax
+98 21 5560 8003
Email
drmr44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of general surgery
Full name of responsible person
Hojatollah Raji
Position
General surgeon
Other areas of specialty/work
Street address
Alzahra hospital
City
Isfahan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
+98 31 1668 4510
Email
hojatollah_raji@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Legal medicine organization
Full name of responsible person
Sayed Mahdi Marashi
Position
Forensic medicine specialist
Other areas of specialty/work
Street address
South side of City Park, Behesht Street,
City
Tehran
Postal code
1114795113
Phone
+98 21 5560 9071
Fax
+98 21 5560 8003
Email
drmr44@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)