| CTRI Number |
CTRI/2023/09/057200 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
30/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Stent v/s stentless surgery for ureteric stone
|
|
Scientific Title of Study
|
Study on the outcome of DJ-stent v/s stentless laparoscopic ureterolithotomy
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JAYANTA K DAS |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
NAZARETH HOSPITAL |
| Address |
NAZARETH HOSPITAL
Second floor , Male Surgery Ward
Laitumkhrah, near police point
NAZARETH HOSPITAL
Second floor , Male Surgery Ward
Laitumkhrah, near police point
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
9862569203 |
| Fax |
|
| Email |
drjayantakr@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYANTA K DAS |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
NAZARETH HOSPITAL |
| Address |
NAZARETH HOSPITAL, C-05 DOCTORS QUARTERS.
NAZARETH HOSPITAL QUARTERS
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
9862569203 |
| Fax |
|
| Email |
drjayantakr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JAYANTA K DAS |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
NAZARETH HOSPITAL |
| Address |
NAZARETH HOSPITAL
Second floor , Male Surgery Ward
Laitumkhrah, near police point
NAZARETH HOSPITAL
Second floor , Male Surgery Ward
Laitumkhrah, near police point
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
9862569203 |
| Fax |
|
| Email |
drjayantakr@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NAZARETH HOSPITAL |
| Address |
NAZARETH HOSPITAL,ARBUTHNOT ROAD NEAR POLICE POINT, LAITUMKHRAH
SHILLONG MEGHALAYA 793003 |
| Type of Sponsor |
Other [TRUST HOSPITAL] |
|
|
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 PURVA AMBURE |
NAZARETH HOSPITAL |
Seconf floor, Male Surgery Ward,Arbuthnot Road, Near Police Point, Laitumkhrah, Shillong - 793003
East Khasi Hills
MEGHALAYA |
7822824675
purvaambure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NAZARETH HOSPITAL SHILLONG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, (2) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DJ STENT URETEROLITHOTOMY |
Following parameters will be compared
1. Operative time and stent placement time
2. Nature and quantity of drain output
3. Duration of drain removal
4. Duration of hospital stay
5. Postoperative complications.
|
| Comparator Agent |
STENTLESS URETEROLITHOTOMY |
Following parameters will be compared
1. Operative time and stent placement time
2. Nature and quantity of drain output
3. Duration of drain removal
4. Duration of hospital stay
5. Postoperative complications. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
80.00 Day(s) |
| Gender |
Both |
| Details |
1.PATIENTS WHO CONSENT
2.PATIENT WITH URETERIC CALCULUS OF SIZE MORE THAN OR QUAL TO 1CM.
2.BILATERAL URETERIC CALCULUS WILL BE CONSIDERED AS TWO SEPERATE CASES
3.PATIENTS MORE THAN EQUAL TO 18YEARS OF AGE |
|
| ExclusionCriteria |
| Details |
1.PREGNANT PATIENT
2.STONE ASSOSIATED WITH RADIOLOGICALLY DIAGNOSED IPSILATERAL STRICTURE URETER
3.PRESENCE OF ANY OTHER RENAL CALCULI ON THE OPERATIVE SIDE. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.OPERATIVE TIME AND STENTING TIME
2.NATURE AND QUANTITY OF DRAIN OUTPUT
3.DURATION OF DRAIN REMOVAL
4.DURATION OF HOSPITAL STAY
|
DAY 3 OF SURGERY, 2 WEEKS, 8 WEEKS, 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POSTOPERATIVE COMPLICATIONS |
12MONTHS |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TO COMPARE THE OUTCOME OF LAPAROSCOPIC URETEROLITHOTOMY WITH AND WITHOUT STENT PLACEMENT. THE PURPOSE OF THE STUDY IS TO FIND OUT WHETEHR PUTTING A STENT IS SUPERIOR/ EQUIVOCAL/INFERIOR TO STENTLESS SURGERIES SELECTION OF THE PATIENT WILL BE RANDOM |