| CTRI Number |
CTRI/2025/08/093612 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomised Controlled Trial to find out whether early urinary catheter removal has a role in early hospital discharge following laparoscopic paediatric pyeloplasty |
|
Scientific Title of Study
|
Effect of early Foley catheter removal on hospital discharge timing following paediatric laparoscopic pyeloplasty: A Randomised Controlled Trial |
| 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 Deepak Chandra Badhani |
| Designation |
Senior Resident MCh Student |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Paediatric Surgery Mother and Child Block 7th Floor AIIMS Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
07409548443 |
| Fax |
|
| Email |
deepakdoc20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishesh Jain |
| Designation |
Professor and Guide |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Paediatric Surgery Mother and Child Block 7th Floor AIIMS Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishesh Jain |
| Designation |
Professor and Guide |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Paediatric Surgery Mother and Child Block 7th Floor AIIMS Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, ANSARI NAGAR, NEW DELHI 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Department of Paediatric Surgery, Mother and Child Block, AIIMS, Ansari Nagar, New Delhi-110029 |
| 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 Deepak Chandra Badhani |
AIIMS |
Department of Paediatric Surgery, Mother and Child Block, 7th Floor, AIIMS, Ansari Nagar, New Delhi
South
DELHI |
07409548443
deepakdoc20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q620||Congenital hydronephrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Removal of Foley catheter on or after post operative day 2 |
Removal of Foley catheter on or after post operative day 2 |
| Intervention |
Removal of Foley Catheter on post operative Day 1 |
Removal of Foley Catheter on post operative Day 1 |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children (less than or equal to 14 years) who are diagnosed with pelviureteric junction obstruction (PUJO) and planned for pediatric laparoscopic pyeloplasty at AIIMS, New Delhi
|
|
| ExclusionCriteria |
| Details |
1. Children who are previously operated (renal or ureteral surgery) or having a recurrent PUJO.
2. Children who are having ectopic kidney, horse shoe kidney, and duplex collecting system.
3. Children who are associated with Vesicoureteric reflux and Lower urinary tract symptoms.
4. Children (including LAR) who are not consenting for the study
5. Children in whom DJ stent was not placed intra operatively.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Hospital Stay (measured in days from the time of shifting child to post operative ward to hospital discharge) for both the groups |
1-5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clavien-Madadi Grading for Postoperative Complications: The frequency & severity of complications will be categorized using the Clavien-Madadi classification (Yes/No) & further categorised into Grade I-II (minor complications) to Grade III-V (severe complications requiring invasive interventions). This will be assessed during hospital admission in post operative stay.
Renal Dynamic Scan Outcomes: Renal function & long-term postoperative outcomes will be assessed through renal dynamic scans (LLEC scan). This will be assessed in Follow up after 3-6 months
|
Assessment of secondary outcomes
1. During hospital stay
2. During follow up- between 3-6 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
03/09/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pelvic-ureteric junction obstruction (PUJO) is one of the most common causes of congenital upper urinary tract obstruction. Antenatal hydronephrosis is seen in 1 in 7 neonates. The incidence of PUJO is one in 1000 to one in 2000 live births. Various options available for management of clinically significant PUJO are Open, Laparoscopic, and Robotic assisted Pyeloplasty. With development of minimal access surgery, the main focus is on to reduce hospital stay to reduce overall cost. Average hospital stay for laparoscopic and robotic assisted paediatric pyeloplasty is 3-5 days. In this study, foley’s catheter will be removed on post operative day 1 in group 1 patient to facilitate earlier discharge from the hospital and to see clinically significant differences as a primary outcome. |