| CTRI Number |
CTRI/2025/03/082683 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the outcomes of two techniques of stone surgery in patients with kidney stones |
|
Scientific Title of Study
|
Comparative analysis of outcomes with Suctioning vs non-suctioning ureteral
access sheath in retrograde intrarenal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun Agarwal |
| Designation |
Registrar, Department of Urology |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room 14, Department of Urology, Kastubra Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7895692678 |
| Fax |
|
| Email |
dr.varunagarwal.uro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Chawla |
| Designation |
Professor, Department of Urology |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room 14, Department of Urology, Kastubra Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
urologyarun@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Varun Agarwal |
| Designation |
Registrar, Department of Urology |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room 14, Department of Urology, Kastubra Hospital, Manipal
KARNATAKA
576104
India |
| Phone |
7895692678 |
| Fax |
|
| Email |
dr.varunagarwal.uro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education Udupi |
| Address |
Kasturba Medical College, Manipal, Udupi, Karnataka |
| Type of Sponsor |
Research institution and 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 Varun Agarwal |
Kasturba Medical College |
Department of Urology, Room 14, Kasturba Hospital, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA |
7895692678
dr.varunagarwal.uro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Access sheath without suction |
Traditional access sheath |
| Intervention |
RIRS without suction access sheath |
RIRS with suction access sheath |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing RIRS at KMC Hospital, Manipal
2. Stone size: less than 2.0cm, max diameter is any one one dimension
3. Pre stented status.
|
|
| ExclusionCriteria |
| Details |
1. Uncorrected coagulopathy.
2. Active UTI
3. Large stone burden greater than 2.0cm
4. Failure of previous treatment
5. Ureteric malformations or anomalous renal anatomy including
low lying kidneys or kidneys with calyceal diverticulae
6. Pregnancy
7. Patients who have undergone ureteral repair surgeries
8. Surgeries converted to PCNL. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stone free rates The percentage of patients with no
residual stones or fragments less than 2mm after surgery as assessed by a follow up NCCT KUB |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Surgeon Assessment Questionnaire to record surgeon experience with
and without suction |
1 day |
| Operative time from the insertion of the endoscope to its removal |
1 day |
| Hospital stays in hours |
1 day |
| Difference in infective & renal function parameters with appropriate tests |
1 day |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
|
|
Date of First Enrollment (India)
|
30/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients eligible for Retrograde Intrarenal Surgery will
be identified from both the OPD and indoor services at KMC Manipal We
will offer potential participants the choice of undergoing the RIRS procedure
as part of their treatment for renal calculi |