| 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
|
|
|
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
|
|
|
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
|