| CTRI Number |
CTRI/2026/02/103480 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Kidney ultrasound measurements in assessing the surgical outcomes in children with blockage at junction of kidney and ureter |
|
Scientific Title of Study
|
Calyx to parenchyma ratio (CPR) in assessing the surgical outcomes in children with pelvi-ureteric junction obstruction undergoing Anderson-Hynes pyeloplasty |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejaswini Girish |
| Designation |
Senior resident |
| Affiliation |
KMC Manipal |
| Address |
Department of pediatric surgery, Kasturba medical college, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482159475 |
| Fax |
|
| Email |
tejaswinigirish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P. Santosh Prabhu |
| Designation |
Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of pediatric surgery, Kasturba medical college, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482159475 |
| Fax |
|
| Email |
santosh.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Tejaswini Girish |
| Designation |
Senior resident |
| Affiliation |
KMC Manipal |
| Address |
Department of pediatric surgery, Kasturba medical college, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482159475 |
| Fax |
|
| Email |
tejaswinigirish@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tejaswini Girish |
| Address |
Department of pediatric surgery, Kasturba hospital, Manipal, Udupi, Karnataka- 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Tejaswini Girish |
Kasturba Hospital |
Room no.35, Department of Paediatric Surgery, Madhav Nagar, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA |
9482159475
tejaswinigirish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed (antenatally/ postnatally) with PUJO with AP diameter of pelvis greater than 1cm on USG and scheduled for Anderson-Hynes pyeloplasty.
2. Informed consent obtained from parents/guardians.
|
|
| ExclusionCriteria |
| Details |
1. Previous renal surgery
2. Presence of other significant renal pathologies (e.g., vesico-ureteric reflux, secondary PUJO).
3. Non-compliance with follow-up protocols.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study will be to study the trends in the CP ratio in pre-operative and post-operative periods of patients undergoing Anderson Hynes pyeloplasty for PUJ obstruction. |
The outcome will be measured at baseline and 6 months following the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study will be to analyse the usefulness of CP ratio as a non-invasive tool to determine the surgical outcomes in patients with PUJ obstruction |
The outcome will be measured at 6 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/03/2026 |
| 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 Applicable |
| 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
|
Pediatric patients diagnosed with pelvi ureteric junction obstruction who are planned for pyeloplasty will be considered for this prospective observational study of 2 years duration. Calyx to parenchyma ratio in the most dilated renal calyx od the affected kdiney will be measured pre op and 6 months post op. These findings will be compared with the more standard imaging tool, i.e., EC scan, to see the surgical outcome in the patients. This will thereby help us to identify whether CP ratio is a significant non invasive marker to prognosticate patients with PUJ obstruciton. |