| CTRI Number |
CTRI/2023/04/051799 [Registered on: 20/04/2023] Trial Registered Prospectively |
| Last Modified On: |
03/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE OUTCOME OF TWO SURGICAL APPROACHES IN LAPAROSCOPIC URETEROLITHOTOMY.
|
|
Scientific Title of Study
|
A Randomized Controlled Study Comparing Transperitoneal vs Retroperitoneal Laparoscopic Ureterolithotomy.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PURVA AMBURE |
| Designation |
DNB TRAINEE GENERAL SURGERY |
| Affiliation |
NAZARETH HOSPITAL |
| Address |
DEPARTMENT OF GENERAL SURGERY
NAZARETH HOSPITAL
NONGRIM ROAD
LAITUMKHRAH
SHILLONG
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
7822824675 |
| Fax |
|
| Email |
purvaambure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYANTA K DAS |
| Designation |
DNB TRAINEE GENERAL SURGERY |
| Affiliation |
NAZARETH HOSPITAL |
| Address |
NAZARETH HOSPITAL
NONGRIM ROAD
LAITUMKHRAH
SHILLONG
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
7822824675 |
| Fax |
|
| Email |
drjayantakr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PURVA AMBURE |
| Designation |
DNB TRAINEE GENERAL SURGERY |
| Affiliation |
NAZARETH HOSPITAL |
| Address |
DEPARTMENT OF GENERAL SURGERY
NAZARETH HOSPITAL
NONGRIM ROAD
LAITUMKHRAH
SHILLONG
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
7822824675 |
| Fax |
|
| Email |
purvaambure@gmail.com |
|
|
Source of Monetary or Material Support
|
| NAZARETH HOSPITAL
NONGRIM ROAD
LAITUMKHRAH
SHILLONG-793003
MEGHALAYA |
|
|
Primary Sponsor
|
| Name |
NAZARETH HOSPITAL |
| Address |
NONGRIM ROAD
LAITUMKHRAH
SHILLONG 793003 |
| Type of Sponsor |
Other [GENERAL 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 |
NONGRIM ROAD
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 |
|
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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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LAPAROSCOPIC URETEROLITHOTOMY RETROPERITONEAL APPROACH
|
FOLLOWING PARAMETERS WILL BE STUDIED- SIDE AND SITE OF STONE - INTRAOPERATIVE FINDINGS SUCH AS STONE SPILLAGE,VESSELS/VISCERAL INJURY, OPEN CONVERSION, INTRACORPOREAL SUTURING TIME, DJ STENTING , POSTOPERATIVE PARAMETRS- POST OP PAIN, POST OP COMPLICATIONS, DAY OF CATHER REMOVAL, DAY OF DRAIN REMOVAL, DURATION OF HOSPITALIZATION, STONE FREE STATUS |
| Intervention |
LAPAROSCOPIC URETEROLITHOTOMY TRANSPERITONEAL APPROACH |
FOLLOWING PARAMETERS WILL BE STUDIED- SIDE AND SITE OF STONE
- INTRAOPERATIVE FINDINGS SUCH AS STONE SPILLAGE,VESSELS/VISCERAL INJURY, OPEN CONVERSION, INTRACORPOREAL SUTURING TIME,
DJ STENTING ,
POSTOPERATIVE PARAMETRS- POST OP PAIN, POST OP COMPLICATIONS, DAY OF CATHER REMOVAL, DAY OF DRAIN REMOVAL, DURATION OF HOSPITALIZATION, STONE FREE STATUS |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18years.
Patient with ureteric calculus of size ≥10mm.
|
|
| ExclusionCriteria |
| Details |
Pregnant women.
Congenital renal and/or ureteric anomalies at the stone site.
Patients not fit for surgery.
Patient having non-functioning kidney.
Patient not consenting for surgery |
|
|
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 |
| STONE FREE RATE |
STONE FREE RATE WILL BE ASSESED ON POSTOPERATIVE DAY 1, 6WEEKS AND 3 MONTHS FOLLOWING SURGERY. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
27/04/2023 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Till date, there has been no consensus as to which method of laparoscopic ureterolithotomy is preferred. The purpose of this study is to evaluate difference between transperitoneal v/s retroperitoneal approach used for Laparoscopic ureterolithotomy and if there is any advantage of one technique over the other. This randomized control study will compare the outcome of the two approaches. Patients with >/= to 10mm ureteric calculus will be randomly assigned to either of the approach groups and evaluated on the basis of peri-operative outcomes and differences and followed up for a period of 3months. |