This study, aimed to assess the outcomes of open surgery versus laparoscopic technique, and compare their complications in those with survival of over and less than a year in patients who need PD for the first time.
Design
Clinical trial study with randomized parallel groups
Settings and conduct
It was conducted on 121 cases admitted for peritoneal dialysis at Alzahra university hospital affiliated to Isfahan University of Medical Sciences, Isfahan, Iran, during the years 2016-17
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients' requirement of peritoneal dialysis for the first time and Patients' willingness of participation in the study
Exclusion criteria: Patients who did not have tolerance of spinal or general anesthesia
Intervention groups
Open surgery and laparoscopy
Main outcome variables
Shot-term and long-term surgery outcomes and complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190525043691N1
Registration date:2019-06-15, 1398/03/25
Registration timing:retrospective
Last update:2019-06-15, 1398/03/25
Update count:0
Registration date
2019-06-15, 1398/03/25
Registrant information
Name
Alireza Amiran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3435 8366
Email address
amiran_al@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
2017-05-05, 1396/02/15
Actual recruitment end date
2018-11-25, 1397/09/04
Trial completion date
2018-11-25, 1397/09/04
Scientific title
Complications of open surgery versus laparoscopic technique in peritoneal dialysis catheter insertion
Public title
Complications of open surgery versus laparoscopic technique in peritoneal dialysis catheter insertion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients' requirement of peritoneal dialysis for the first time
Patients' willingness of participation in the study
Exclusion criteria:
Patients who did not have tolerance of spinal or general anesthesia
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
121
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups randomly in simple method using Random Allocation software (version 1.0). In this method, all patients were provided a number by the software, and those with even number were supposed as members of open surgery, and those with odd numbers were members of the other group.
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
The ethical committee of Isfahan School of Medicine
Street address
School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
936183
Health conditions studied
1
Description of health condition studied
The outcomes and complication of of open surgery versus laparoscopic technique in catheter insertion
ICD-10 code
T85.6
ICD-10 code description
Mechanical complication of other specified internal and external prosthetic devices, implants and grafts
Primary outcomes
1
Description
Surgery outcomes and complications
Timepoint
12 months after the surgery
Method of measurement
observation and asking from the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Open surgery
Category
Treatment - Surgery
2
Description
Intervention group: Laparoscopy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Alireza Amiran
Street address
Alzahra Hospital, Sofeh Blv.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3790 3011
Email
amiran_al@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice-Chancellor for Research and Tecnology, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
amiran_al@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Alireza Amiran
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Amiran
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3435 8366
Email
amiran_al@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Morteza Shahbandari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular Surgery
Street address
Alzahra Hospital, Sofeh Blv.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 3011
Email
mshahbandari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Amiran
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3435 8366
Email
amiran_al@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
As an article, all the important data will be published.
When the data will become available and for how long
After completing data analysis, and for ever
To whom data/document is available
All the researchers without any limitation
Under which criteria data/document could be used
for multicentric research, and meta-analysis studies, it can be statistically analyzed again.
From where data/document is obtainable
They can send their requests to Alireza Amiran, via his email address (amiran_al@yahoo.com) or mailing address (Department of Surgery, Alzahra Hospital, Sofeh Blv., Isfahan, Iran).
What processes are involved for a request to access data/document
if it be proven to researchers that a person or institution really needs the data for a research, it will be set.