(1) Objective: Application of mini-laparoscopy for ureteral stone.
(2) Design: We have designed a prospective randomized clinical trial to compare mini-laparoscopy and conventional laparoscopic surgery in patients with ureteral stones.
(3) Setting and conduct: Patients with upper ureteral stone will be enrolled in the study and randomly will enter to standard or mini laparoscopic arms. Data will be collected in a prospective manner.
(4) Participants including major eligibility criteria: Ureteral stones larger than 10 mm which failed to manage with medical expulsive therapy, ureteroscopy or shock wave lithotripsy will be included.
Main exclusion criteria: patients with very high risk for general anaesthesia; coagulation disorders; stones at distal ureter; pyonephrosis; pregnancy.
(5) Intervention: Patients will randomly assign to undergo standard or mini laparoscopic surgery using table of random numbers. Mini laparoscopic ureterolithotomy (MLU) defines as one 5-mm trocar for a 5-mm laparoscope and two or three 3-mm ports. At the other arm, standard laparoscopic ureterolithotomy (SLU) includes one 12-mm port for a 10-mm laparoscope and three 5-mm ports. Transperitoneal approach will be used for all patients in both arms.
(6) Main outcome measures: Pain intensity will be registered by the patient using Numeric pain rating scale (NPRS) at several time intervals after surgery. To evaluate cosmetic results, Vancouver scar scale (VSS) will be completed by a third party for all patients 3 months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062334639N1
Registration date:2017-07-05, 1396/04/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
Sepehr Hamedanchi
Name of organization / entity
Urmia university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 441 2600
Email address
sepehrhamedanchi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2018-01-01, 1396/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing standard laparoscopy and mini laparoscopy for management of ureteral stone
Public title
Mini laparoscopy for ureteral stone
Purpose
Other
Inclusion/Exclusion criteria
Main inclusion criteria:
ureteral stones larger than 10 mm which failed to manage with medical expulsive therapy, ureteroscopy or shock wave lithotripsy
Main exclusion criteria:
patients with very high risk for general anaesthesia;
coagulation disorders;
stones at distal ureter;
pyonephrosis;
pregnant patients
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of Shahid Beheshti medical university
Street address
Shahid Bheshti university of medical sciences, Yaman street, Chamran highway
City
Tehran
Postal code
Approval date
2017-01-20, 1395/11/01
Ethics committee reference number
IR.SBMU.UNRC.1395.20
Health conditions studied
1
Description of health condition studied
ureteral stone
ICD-10 code
N20.1
ICD-10 code description
caculus of ureter
Primary outcomes
1
Description
cosmesis
Timepoint
3 months after surgery
Method of measurement
Vancouver scar scale
2
Description
pain
Timepoint
6, 12 ,24, 48, 120 hours after surgery
Method of measurement
by the patient using Numeric pain rating scale
Secondary outcomes
1
Description
rehabilitation period
Timepoint
days to resume normal activity
Method of measurement
ask from patient
2
Description
complications
Timepoint
3 month
Method of measurement
lab and imaging
3
Description
operating time
Timepoint
during surgery
Method of measurement
clock
4
Description
bleeding
Timepoint
12 hours after surgery
Method of measurement
Hb level
Intervention groups
1
Description
Intervention:
Mini laparoscopic ureterolithotomy will be done for patients with upper ureteral stone.
Mini laparoscopic ureterolithotomy (MLU) defines as one 5-mm trocar for a 5-mm laparoscope and two or three 3-mm ports. Transperitoneal approach will be used for all patients.
Colon will be mobilized medially and after releasing the ureter, incision will be made longitudinally over the stone site on the ureteral wall and stone will be pulled out. After placing a jj stent, ureteral opening will be repaired with separate stiches and stone will extract from camera port site
Category
Treatment - Surgery
2
Description
Control:
standard laparoscopic ureterolithotomy (SLU) includes using one 12-mm port for a 10-mm laparoscope and three 5-mm ports.
Colon will be mobilized medially and after releasing the ureter, incision will be made longitudinally over the stone site on the ureteral wall and stone will be pulled out. After placing a jj stent, ureteral opening will be repaired with separate stiches and stone will extract from camera port site
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejhad hospital
Full name of responsible person
Sepehr Hamedanchi
Street address
9th Boostan, Pasdaran street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti university of medical sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti university of medical sciences, Yaman street, Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
Shahid Beheshti university of medical siences
Full name of responsible person
Sepehr Hamedanchi
Position
Fellow of endourology
Other areas of specialty/work
Street address
Labbafinejhad hospital, 9th Boostan, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 2254 8886
Fax
Email
sepehrhamedanchi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti university of medical sciences
Full name of responsible person
Sepehr Hamedanchi
Position
fellow of endourology
Other areas of specialty/work
Street address
Labbafinejhad hospital, 9th Boostan, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 2254 8886
Fax
Email
sepehrhamedanchi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti university of medical sciences
Full name of responsible person
Sepehr Hamedanchi
Position
fellow of endourology
Other areas of specialty/work
Street address
Labbafinejhad hospital, 9th Boostan, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 2254 8886
Fax
Email
sepehrhamedanchi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)