Comparison of surgical outcomes and quality of life in patients after laparoscopic donor nephrectomy versus open surgery
Design
A non-blinded randomized clinical trial (open label) with parallel groups will be conducted on 88 participants. The participants will be randomly allocated to one of the surgical groups, laparoscopic or open, using random allocation software.
Settings and conduct
In this study, kidney transplant patients (Kidney donors) will be enrolled at Urmia Imam Khomeini Hospital. The study will be conducted without blinding.
Participants/Inclusion and exclusion criteria
In this clinical trial, 88 kidney transplant patients (kidney donors) of any age and gender will be enrolled.
Intervention groups
Surgery will be performed laparoscopically in one group and open surgery in another group.
Main outcome variables
Kidney function; level of satisfaction; quality of life; post-surgical complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180625040232N10
Registration date:2023-06-21, 1402/03/31
Registration timing:prospective
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Saman Farshid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
farshid.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of surgical outcomes and quality of life in patients after laparoscopic donor nephrectomy versus open surgery
Public title
Comparison of surgical outcomes in laparoscopic donor nephrectomy versus open surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Kidney donors
No complexity in the donor kidney vessels
Recipient aged 18–65 years
Exclusion criteria:
History of abdominal surgery
Coagulation disorders
having a collateral artery branch in CT angiography
Haemolytic uraemic syndrome
Focal segmental glomerulosclerosis and oxalosis in the recipient.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to one of the laparoscopic or open surgical groups using computer-generated numbers produced by the Random allocation software. Thus, in this software, the number of groups and the total sample size will be entered, and then the "randomization" will be implemented in the block section. Then, the computer-generated number list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups.For example, if the first patient in the generated list is assigned to the laparoscopic surgery group, the next patient may be placed in either the laparoscopic or open surgery group. Thus, the randomization process will continue until the final sample size is reached.
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
Ethics Committee of Imam Khomeini University hospital- Urmia University of Medical Sciences