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CTRI Number  CTRI/2024/04/065091 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Two different surgical techniques]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of modified versus traditional early recovery after surgery on new kidney graft outcomes following kidney transplant 
Scientific Title of Study   The effect of modified versus conventional ERAS on clinical and graft outcomes in kidney transplant recipients: 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  Manjunath Maruti Pol 
Designation   
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9990187137  
Fax    
Email  manjunath.pol123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pritee Trivedee 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India 
Phone  9717628127  
Fax    
Email  tpritee12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pritee Trivedee 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India 
Phone  9717628127  
Fax    
Email  tpritee12@gmail.com  
 
Source of Monetary or Material Support  
Department of Surgical Disciplines AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  Department of Surgical Disciplines, fourth floor, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi 
Type of Sponsor  Government medical college 
 
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 
Dr Pritee Trivedee  AIIMS Delhi  Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi, South DELHI
South
DELHI 
9717628127

tpritee12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A: Modified ERAS  Minimal incision + ICE bag technique + TAP block catheter (ropivacaine TID) with or without PCA- fentanyl infusion  
Comparator Agent  Group B: Conventional ERAS  Conventional hockey stick incision + No ICE bag technique + Parenteral or oral analgesics with or without PCA- fentanyl infusion  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • 18 years to 70 years
• Both genders
• Live donor kidney transplant
 
 
ExclusionCriteria 
Details  • Patients less than 18 years and more than 70 years
• Patient refusal to participate in the study
• Pregnant or lactating mother
• patients with allergy to local anaesthetic drugs
• Extended criteria live donors (donor age more than 60 years or donor age more than 50 years with at least two comorbidities)
• Deceased donor transplant
• Combined liver – kidney or kidney – pancreas transplant.
• Follow-up of less than 3 months after kidney transplant
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Clinical and graft outcome score   up to 7 days 
 
Secondary Outcome  
Outcome  TimePoints 

1. Length of hospital stay
2. Time to first oral intake
3. Time to return of activity
4. Pain score (VAS)
5. Post-operative opioid consumption days
6. Postoperative complications (vascular, urological, and graft parenchymal)
7. Readmission rates
8. Cost-analysis: Hospital stay charges, hemodialysis sessions, interventional radiology procedures, blood tests, trough levels, biopsy charges etc.
 
1. days to weeks
2. up to 7 days
3. up to 7 days
4. VAS score
5. up to 7 days
6. up to 3 months
7. up to 3 months
8. In Rupees 
 
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)   15/04/2024 
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="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  

 Justification for the study:

1.   Kidney transplantation (KT) is best form of renal replacement therapy that gives best quality of life and survival benefits when compared to dialysis in patients with end stage renal disease (ESRD).

2.   The enhanced recovery after surgery pathways is used to optimise perioperative treatment and improve outcomes. It seeks to reduce post-operative opioids intake and reduce length of stay (LOS). ERAS is relatively not a new concept and has been widely used to improve perioperative care in multiple different surgeries. The economic impact of reduced LOS due to applied ERAS protocols has been highlighted in colorectal surgeries.

3.   There is a limited data on ERAS in KT patients. The ERAS in liver transplants showed shorter LOS and significant reduction in hospital costs. The perioperative cost of KT constituted about a third of the first year’s costs. Therefore, an intervention to reduce cost without affecting clinical and graft outcome is warranted.

4.   The majority of studies on ERAS involving transplant recipients were retrospective case series, prospective cohorts with historical cohorts. All concluded that the ERAS is feasible in KT recipients. There were no reports of severe peri-operative complications, readmission rates, or graft failure due to early discharge or community-based peri-operative management.

5.   Following the success of feasibility trials in 2016, researchers are now focussed on pain control with non-opioids such as, pregabalin and ketorolac. All this is aimed improve patient experience and LOS. However, none of the studies have focussed on improving graft function or integrating graft function within the ERAS protocol. Additionally, statistics on complete cost analysis and re-admission rates (conditions needing intervention such as renal artery stenosis, post-operative collection, and urological complications) are lacking.

6.   Based on our findings, the ERAS approach is applicable, and KT recipients can be safely discharged after post-transplant day 5 provided there is no indication for parenteral treatment. However, in the absence complete cost-analysis it appears that many surgeons in the developed countries used the ERAS protocol and began transitioning recipients from in-hospital to community based post-operative care (from day 4 or 5 onwards), and projected cost-saving due to reduced LOS. In view of inadequate graft recovery and possibility of delayed complications that might appear gradually, patients were advised to stay near the hospital and be in close contact with a nephrologist for dialysis and periodic check-up for regular evaluation. Unlike in the developed countries, health insurance companies in India would welcome early discharge protocols but will not extend their coverage for community based post-operative management (that is community accommodation will not be covered by health insurance). Also, an early discharge does not preclude the need for close infection surveillance within the recipients’ community. Furthermore, due to considerable variability of CNI metabolisers in India, at least two trough levels (post-operative day 1 and 4) would be required to achieve an adequate drug level prior to discharge.  

7.   Secondly, there is no study in the English literature that compares the two-treatment protocol [modified ERAS versus Conventional ERAS] in patients undergoing KT surgery. However, there are a few articles published in medical journals that are either retrospective case series or prospective observational study with historical cohorts. Ahmed Halawa et al. (2018) included live and deceased donor transplants and compared them to historical cohorts. [1] Although they concluded that the ERAS benefitted both living and deceased donor transplant recipients and reduced LOS, the protocol was not followed by everyone, the groups were heterogeneous, satisfactory score was not calculated for all, and comprehensive cost analysis was never performed. On the contrary, we believe that failure in ERAS group is mostly connected to graft function recovery rather than clinical recovery alone, and LOS among live donor transplants is determined by polyuria, graft recovery and CNI trough levels.

8.   Lastly, a study comparing the ERAS to historical cohorts (prior to 2010) means the two groups differ in many ways including immunosuppressive regimen and surgical procedure, and their results are not completely reflective. 

 

Reference:

1.   Halawa, A, Rowe, S, Roberts, F, et al. A Better Journey for Patients, a Better Deal for the NHS: The Successful Implementation of an Enhanced Recovery Program after Renal Transplant Surgery. Exp. Clin. Transplant. 2018, 16, 127–132

 
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