| CTRI Number |
CTRI/2025/01/079193 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Protocol for early recovery after surgery in children undergoing laparoscopic pyeloplasty |
|
Scientific Title of Study
|
Enhanced recovery after surgery (ERAS) protocol in children undergoing laparoscopic pyeloplasty: A Feasibiity 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 |
sabina khanal |
| Designation |
senior resident |
| Affiliation |
PGIMER , chandigarh |
| Address |
Department of anesthesia and intensive care , 4th floor nehru building, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7973369424 |
| Fax |
|
| Email |
sabinakh36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indu Mohini sen |
| Designation |
Professor |
| Affiliation |
PGIMER , Chandigarh |
| Address |
Department of anesthesia and intensive care , 2nd floor , room no 29 block D , nehru building ,PGIMER , chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009532 |
| Fax |
|
| Email |
indumohini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Indu Mohini sen |
| Designation |
Professor |
| Affiliation |
PGIMER , Chandigarh |
| Address |
Department of anesthesia and intensive care , 2nd floor , room no 29 block D , nehru building ,PGIMER , chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009532 |
| Fax |
|
| Email |
indumohini@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER , CHANDIGARH , India , 160012 |
|
|
Primary Sponsor
|
| Name |
Dr Sabina khanal |
| Address |
Department of anesthesia and intensive care , 4th floor nehru block , PGIMER |
| 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 Sabina Khanal |
PGIMER |
6th floor , block A , APC OT complex , Advance pediatric center
Chandigarh
CHANDIGARH |
7973369424
sabinakh36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (2) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patient of age group 6 month - 5 years undergoing laparoscopic pyeloplasty. |
|
| ExclusionCriteria |
| Details |
Parental refusal to participate in the study.
Conversion of laparoscopic to open procedure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compliance to ERAS protocol : This would be measured using ERAS protocol checklist at the time of discharge |
compliance to ERAS protocol : At the time pof discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment og postoperative pain, postoperative recovery time, emergence delirium, time to extubation after stopping inhalational agent and intraoperative and postoperative complication , readmission rate , length of hospital stay |
Postoperative : Every 30 min in PACU and 6 hrly till discharge
Complication : followup for 30 days post discharge |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/02/2025 |
| 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="0"
Months="10"
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
|
This feasibilty study will be enrolling the infants and children of age group 6 month to 5 year undergoing laparoscopic pyeloplasty . compliance to ERAS protocol preoperative , intraoperative and postoperative will be assessed.
As a secondary outcome role of ERAS in extubation ,Postoperative pain score and recovery,emergence delirium will be measured using valid tools, also the complications both intraoperative and postoperative, length of hospital stay will be assessed. Telephonic followup till 30 days will be done for any complication. |