Purpose: Comparing the follow up results of the patients operated by prepritoneal tunneling tecknique with the patients operated by open surgery. Study method: non random interventional.
Study Population: The ESRD (end stage renal disease) patients comming to Emam Reza and Ghaem's nephrology clinics, Mashhad, Iran.
Inclusion criteria: the patients should have the capacity to know how to take care of peritoneal dialysis Catheter and follow the given instructions.
Exclusion criteria: The patients who do not refer to the hospital for the follow up check ups or they are not accessible in anyway. Sample size: 200 patients.
Intervention: using laparoscopic preperitoneal tunneling tecknique or open surgery for laparoscopic CAPD catheter placement. Outcome: peritonitis, inflow and outflow of dialysis fluid, catheter migration, cath. block, Omental wrapping, tunnel infection, leak, port-site hernia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810231820N2
Registration date:2011-04-18, 1390/01/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-18, 1390/01/29
Registrant information
Name
Mohammad-Hadi Saeed Modaghegh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2505
Email address
modaghegh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2001-03-21, 1380/01/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
New Laparoscopic technique (preperitoneal tunneling) vs open surgical placement of peritoneal dialysis catheter
Public title
Preperitoneal tunneling: A novel technique in peritoneal dialysis catheter insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients should have the capacity to know how to take care of peritoneal dialysis Catheter and follow the given instructions.
Exclusion criteria:The patients who do not refer to the hospital for the follow up check ups or they are not accessible in anyway.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreyshi building, Daneshgah av.
City
Mashhad
Postal code
Approval date
2008-06-13, 1387/03/24
Ethics committee reference number
86181
Health conditions studied
1
Description of health condition studied
peritoneal dialysis catheter insertion
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
Peritonitis
Timepoint
monthly
Method of measurement
inspection and examination
2
Description
Fluid flow
Timepoint
immediately after surgery then monthly
Method of measurement
examinatin
3
Description
Cath. migration
Timepoint
monthly
Method of measurement
KUB
4
Description
Omental wrapping
Timepoint
monthly
Method of measurement
laparoscopy
5
Description
Cath. block
Timepoint
monthly
Method of measurement
based on cath function
6
Description
Tunnel infection
Timepoint
monthly
Method of measurement
inspection and examination
7
Description
Leak
Timepoint
monthly
Method of measurement
inspection and examination
8
Description
Port site hernia
Timepoint
monthly
Method of measurement
Inspection and examination
Secondary outcomes
1
Description
Dialysis start time
Timepoint
weekly
Method of measurement
Observation
2
Description
Anesthesia duration
Timepoint
there is no Secondary outcome time point
Method of measurement
operation duration
Intervention groups
1
Description
Laparoscopic prepritoneal CAPD cath. placement
Category
Treatment - Surgery
2
Description
Control:open surgical technique for placement of CAPD cath.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Endovascular research center, Emam Reza Hospital
Full name of responsible person
Rajabnejad Yaser
Street address
Emamreza hospital, Ebnesina av.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mr Bozorgnia
Street address
Emam Reza Hospital
City
Mashhad
Grant name
برنامه10506/فصل2
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad Univesity of Medical Sciences
Full name of responsible person
Rajabnejad Yaser
Position
General practitioner
Other areas of specialty/work
Street address
Endovascular Research Center, Emam Reza Hospital
City
Mashhad
Postal code
Phone
+98 936 672 3271
Fax
Email
rajabnejady861@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endovascular Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hady Modaghegh
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Emamreza Hospital
City
Mashhad
Postal code
Phone
+98 51 1852 5311
Fax
Email
modaghegh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Rajabnejad Yaser
Position
General practitioner
Other areas of specialty/work
Street address
City
Postal code
9137913316
Phone
+98 51 1852 5311
Fax
+98 51 1852 5311
Email
raj.yaser@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)