Objective:
We can introduce Mini-laparoscopic donor nephrectomy as an acceptable alternative for standard or laparoendoscopic single site surgery (LESS) if our results reveal good peri and postoperative outcomes with acceptable graft survival.
Design:
After pilot study using 20 donors and assessment of primary results, a single blind randomized clinical trial was designed.
Setting and conduct:
This project will be performed in two groups of donors (50 cases in each group) who undergo standard and mini laparoscopic surgery. Each donor and related recipient will be followed for three months for glomerular filtration rate (GFR), serum creatinine, blood pressure and cosmetic appearance of scars.
Participants including major eligibility criteria:
The cases who candidate for laparoscopic donor nephrectomy
Exclusion criteria:
Right donor nephrectomy, vascular anomaly, previous history of laparotomy
Intervention:
Standard laparoscopic donor nephrectomy in one group and Mini-laparoscopic donor nephrectomy in the other group
Main outcome measures (variables):
Warm ischemic time - Hospital stay - Operative time - Blood pressure in recipient - Cosmetic appearance of trocars scar three months after operation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207187457N10
Registration date:2012-10-08, 1391/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-08, 1391/07/17
Registrant information
Name
Shabnam Golshan
Name of organization / entity
Urology and Nephrology Research Center (UNRC)
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
shgolshan@unrc.ir
Recruitment status
Recruitment complete
Funding source
This project will be supported by BMN (Bonyad Melli Nokhbegan) and UNRC (Urology and nephrology research center of Shahid Behshti Medical University).
Expected recruitment start date
2012-08-21, 1391/05/31
Expected recruitment end date
2013-02-21, 1391/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of mini-laparoscopy and standard laparoscopy in kidney donors
Public title
Importance of Mini-laparoscopy in kidney donation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The cases who candidate for laparoscopic donor nephrectomy.
Exclusion criteria:
Right donor nephrectomy, vascular anomaly, previous history of laparotomy
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Kind of randomization: Simple random sampling
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urology and Nephrology Research Center (UNRC) related to Shahid Beheshti Medical University (SBMU)
Street address
No#103, 9th Boostan St., Pasdaran Ave.
City
Tehran
Postal code
Approval date
2012-05-31, 1391/03/11
Ethics committee reference number
41573/م/ت/الف
Health conditions studied
1
Description of health condition studied
Renal failure (kidney donation to patients with ESRD)
ICD-10 code
N17- N18 -
ICD-10 code description
Kidney damage with severely decreased GFR (15-29 mL/min)
Primary outcomes
1
Description
Warm ischemic time
Timepoint
During operation
Method of measurement
From renal artery clamping to beginning of cold saline irrigation
2
Description
Hemoglobin
Timepoint
Before operation - the day after operation - at discharge time
Method of measurement
Laboratory test (CBC)
3
Description
Admission time
Timepoint
From operation to discharge
Method of measurement
Number of admission day
4
Description
Appearance of trocars scar
Timepoint
Three months after operation
Method of measurement
Observation and determination of scars
5
Description
GFR in recipient
Timepoint
Three months after operation
Method of measurement
Kortchof formula
6
Description
Blood pressure in donor
Timepoint
Three months after operation
Method of measurement
Using assessment of blood pressure
Secondary outcomes
1
Description
Bleeding
Timepoint
During operation and in recovery room
Method of measurement
Regarding to the measurement of blood extracted from the suction
2
Description
Requirement to analgesic and opium
Timepoint
In recovery room and unit admission
Method of measurement
Assessment of dose injected IM or IV
3
Description
Visceral injury
Timepoint
During operation
Method of measurement
According to direct vision of injury or delayed manifestations in postoperative days
Intervention groups
1
Description
Control group: 50 patients who underwent laparoscopic standard donor nephrectomy
Laparoscopic standard nephrectomy: this operation is performed using one 12 mm port for video scope, two 5 mm for grasping and scissoring and one 10 mm port for vascular clipping. The specimen is extracted from pfananestiel incision.
Category
Treatment - Surgery
2
Description
Intervention group: 50 patients who underwent donor nephrectomy using mini-laparoscopic approach.
Mini-laparoscopic approach: This operation is performed using two 3.5 mm ports for grasping and scissoring, one 5 mm port for video scope and one 10 mm port in the pfanenstiel incision.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad Medical Center
Full name of responsible person
Mohammad Hossein Soltani
Street address
Shahid Labbafinejad Medical Center - Boostan 9th St. - Pasdaran Ave.