| CTRI Number |
CTRI/2025/10/096043 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Rate of Implementation of
Enhanced Recovery After Surgery (ERAS) Protocol in Children |
|
Scientific Title of Study
|
Compliance rate of Implementation of
Enhanced Recovery After Surgery (ERAS) Protocol in
Children undergoing Genitourinary Surgery–
A Prospective Observational Study |
| 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 Deepanjali Pant |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Ot 22 , SSRB , BLOCK D , Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New
Delhi-110060, INDIA
Central
DELHI
110060
India |
| Phone |
9818271871 |
| Fax |
|
| Email |
deepanjalipant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepanjali Pant |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
OT 22 , SSRB , BLOCK D , Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New
Delhi-110060, INDIA
Central
DELHI
110060
India |
| Phone |
9818271871 |
| Fax |
|
| Email |
deepanjalipant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Malik |
| Designation |
Post DNB diploma trainee |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
SSRB BLOCK D , Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New
Delhi-110060, INDIA
Central
DELHI
110060
India |
| Phone |
7015402157 |
| Fax |
|
| Email |
maliksushil0000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital, New Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine, 5th Floor SSRB Block D,
SGRH, Old Rajinder Nagar, Delhi 110060 Sir Ganga Ram hospital, New Delhi-110060, INDIA |
| 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 Deepanjali Pant |
Sir Ganga Ram Hospital |
OT 22, 7th Floor SSRB Block D, Sir Ganga Ram Hospital , Old
Rajinder Nagar, Delhi 110060 Sir Ganga
Ram hospital, New Delhi-110060, INDIA
Central
DELHI
Central
DELHI |
9818271871
Deepanjalipant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Elective and emergency surgical patients undergoing genitourinary surgery
2) ASA physical status I-II |
|
| ExclusionCriteria |
| Details |
1. Patients needing post-op ICU admissions
2. Complex congenital anomalies
3. Refused to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compliance rate of ERAS protocol implementation |
In perioperative period and Outcome will be assessed in the postoperative period with in 24 hours of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of stay
Rate of ED visit / readmission / re-operation with in 48 hours
Parental satisfaction after the surgery |
With in 48 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
25/10/2025 |
| 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="1"
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
|
Enhanced Recovery After Surgery (ERAS) protocols were initially developed for colorectal
surgery in the early 2000s, but have since expanded to various surgical specialties. In 2010, the
ERAS society was officially founded to promote and standardize ERAS practices worldwide.
Enhanced Recovery After Surgery (ERAS) protocols are evidence-based multidisciplinary
perioperative care pathways designed to reduce perioperative stress, optimise recovery, and
improve surgical outcomes in adults. While well-established in adult populations, the application
of ERAS protocols in paediatric surgery remains limited. There are very few studies in literature
on implementation of ERAS protocols in paediatric surgical patients.
In this proposed prospective observational study paediatric patients (1–18 years of age)
undergoing genitourinary surgery will be enrolled and the compliance of the ERAS protocol
parameters will be assessed and recorded if more than or equal to 70% parameters are followed,
ERAS protocol compliance will be considered as met. For duration of stay in hospital patient will
be followed and total number of days of hospitalization will be recorded. For rate of emergency
department visit / readmissions / reoperation follow up will be done and if within 48 hours any of
these occurs it will be recorded and parental satisfaction will be assessed by customized parental
satisfaction score after the postoperative period.
|