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CTRI Number  CTRI/2024/06/068411 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [AMBULATION, HEALTH EDUCATION]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To assess the quality of recovery, patient satisfaction and hospital stay of Renal Transplant patient after Nurse driven Enhanced Recovery After Surgery programme. 
Scientific Title of Study   A study to assess the effectiveness of Nurse Driven Enhanced Recovery after surgery Programme(ERAS)on quality of recovery,patient satisfaction and hospital stay of patients undergoing Renal Transplant at AIIMS,New Delhi 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shashi 
Designation  Msc nursing student  
Affiliation  AIIMS New Delhi 
Address  Porta cabin 1 ,2nd floor College of Nursing ,AIIMS New Delhi

South
DELHI
110029
India 
Phone  8130191002  
Fax    
Email  aiimsshashi27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Latha Venkatesan  
Designation  Professor cum Principal 
Affiliation  AIIMS,New Delhi 
Address  Principal office Ground floor College of Nursing AIIMS,New Delhi

South
DELHI
110029
India 
Phone  9310502069  
Fax    
Email  latha6901@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Shashi 
Designation  Msc Nursing Student  
Affiliation  AIIMS ,New Delhi  
Address  Porta cabin 1 ,2nd floor College of Nursing ,AIIMS New Delhi
College of Nursing ,AIIMS
South
DELHI
110029
India 
Phone  8130191002  
Fax    
Email  aiimssshashi27@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences ,New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  College of Nursing AIIMS ,New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shashi  All India Institute of Medical Sciences,New Delhi  AB4 WARD,4th floor, Main building and KTP Unit ,5th floor ,Surgery block ,All India Institute Of Medical Sciences, New Delhi
South
DELHI 		 8130191002

aiimsshashi27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITEE FOR POST GRADUATE RESEARCH, All INDIA INSTITUTE OF MEDICAL SCIENCES,ANSARI NAGAR, NEW DELHI 110029, Room no 102 ,Ist floor Old ot block  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N185||Chronic kidney disease, stage 5,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nurse driven ERAS protocol   health education about early ambulation, infection prevention ,medicine adherence will be given.Pain scoring 4 hourly and pain management for 2 months 
Comparator Agent  routine preoperative and post operative care   routine preoperative and postoperative care for first two months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient posted for Renal Transplant in AB4 and KTP Unit AIIMS New Delhi.

Those who are willing to participate in study.

 
 
ExclusionCriteria 
Details  Those who are not willing to participate in study.

Patients receiving transplant from Cadaveric donors.

Pediatric patient
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Nurse Driven Enhanced Recovery after surgery Programme (ERAS) on patient satisfaction, quality of recovery and hospital stay of renal transplant patients.  16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To find the association between quality of recovery, patient satisfaction & hospital stay of patients undergoing renal transplantion with selected demographic variables  16 weeks 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   01/08/2024 
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="4"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aiimsshashi27@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Enhanced Recovery After Surgery protocol is a multimodal, multidisciplinary approach to the care of the patients after surgery. The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization. Enhanced recovery after surgery (ERAS) protocols has been in trend from last few years in  many different surgical specialties due to their benefits related to the significant reduction in length of hospital stay and increasing patient satisfaction and also reduce the post operative complications. Nurses are the health professionals who spend the most time with patients throughout the perioperative  and postoperative time.  Increasing nurses involvement in ERAS and Continual training of nurses for ERAS  is becoming more importsnt in care of patients after surgery.

Renal transplant are more prone to post operative complications  like pain, nausea, vomiting. Enhanced Recovery After Surgery (ERAS) program facilitate early mobility and recovery  and shorten the length of hospital stay  of renal transplant patients . ERAS represents a new way of thinking about how we care for patients undergoing major surgery. It helps patients recover from their operation sooner, so that  patient can return to normal life as quickly as possible. Numerous research reports have shown that using ERAS as opposed to traditional care has significant positive effects on recovery.
In India, a study showed a 35% decrease in hospital stays without any increased readmissions or complications after inclusion of ERAS pathways. So by implementing nurse led ERAS programme the duration of hospital stay can be shorten and quality of recovery will be enhanced , also possiblities of readmission for any complication can also be minimised. This study will develop an evidence in effectivness of nurse led ERAS programme in improving quality of recovery, reducing their duration of hospital stay and increasing satisfaction among renal transplant patients.



 
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