| CTRI Number |
CTRI/2020/07/026421 [Registered on: 07/07/2020] Trial Registered Prospectively |
| Last Modified On: |
22/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefit and side effect of ureteric stunting after ureteric stone surgery |
|
Scientific Title of Study
|
A Randomised clinical trial comparing outcome of Stented versus Non-stented strategy in uncomplicated Ureteorenoscopic lithotripsy (URSL) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumya Mondal |
| Designation |
Assistant Professor |
| Affiliation |
IPGMER AND SSKM HOSPITAL |
| Address |
Department Of Urology
IPGMER and SSKM Hospital
A J C Bose road
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433119700 |
| Fax |
|
| Email |
dr.soumya.mondal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Abhishek |
| Designation |
Post doctoral Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department Of Urology
IPGMER and SSKM Hospital
A J C Bose road
Kolkata
WEST BENGAL
700020
India |
| Phone |
8603942053 |
| Fax |
|
| Email |
dranandabhishek@icloud.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Abhishek |
| Designation |
Post doctoral Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
DEPARTMENT OF UROLOGY
IPGMER and SSKM Hospital
A J C Bose road
Kolkata
WEST BENGAL
700020
India |
| Phone |
8603942053 |
| Fax |
|
| Email |
dranandabhishek@icloud.com |
|
|
Source of Monetary or Material Support
|
| department of urology, IPGMER and SSKM Hospital, Government of west Bengal |
|
|
Primary Sponsor
|
| Name |
depatment of urology |
| Address |
IPGMER And SSKM Hospital,A. J. C. Bose Road |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand abhishek |
IPGMER And SSKM Hospital |
Department of urology
244 A J C Bose road flyover
Kolkata
WEST BENGAL |
8603942053
dranandabhishek@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research oversight committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Double j stent |
In Intervention Group, Double J stent Placed after Ureteroscopic Surgery for 4 week post surgery after that stent was removed. |
| Comparator Agent |
Without Double J stent |
In Comparison Group, No Stent Will Be Placed After Ureteroscopic Surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral Solitary Calculi Size <15 mm |
|
| ExclusionCriteria |
| Details |
History of pyelonephritis
Solitary kidney
Ureteric injury
Concomitant stone at other place in urinary tract
Ureteric stricture |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To study and compare the sociodemographic and morbidity parameters among the study subjects in two groups.
2) To assess incidence of complications in both group study subjects after URSL and make comparison.
3) To determine the average stone free rate in both the groups. |
post operative day 3, week 1, week 2 week 3, week 4 after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) need of analgesic in post operative period.
2) mean hopspital stay.
3) average duration of surgery |
intra operative, post operative day 3, week 1, week 2 week 3, week 4 after surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/07/2020 |
| Date of Study Completion (India) |
18/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ureteroscopic lithotripsy, extracorporeal shock wave lithotripsy (ESWL), medical therapy, percutaneous nephrolithotomy and laparoscopic surgery are all the indicated for the treatment of ureteral stones. URSL and ESWL are the most widely used techniques to clear stones with high degree of success [3]. Procedure of choice for treating ureteric calculi especially mid and lower ureteric calculi is ureterorenoscopic lithotripsy.There are specific indications for D J placement after URSL such as ureteral injury ureteral edema with or without stone impaction, ureteral perforation, previous history of or present renal failure, URSL done in solitary kidney or a transplant kidney. Despite such indications for DJ stenting, stenting is being injudiciously by urologist inspite of morbidity associated with stenting. Worldwide data shows 13% of urologists place DJ stent after every endoscopic stone surgery (URSL/RIRS) and 66% of the urologists place a DJ stent more than half of the times after URSL/RIRS[9]. This numbers would be further higher in India. There is still controversy regarding placement of ureteral stent after uncomplicated URS stone surgery. |