| CTRI Number |
CTRI/2024/02/062646 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Process of Care Changes Other (Specify) [Implementing enhanced recovery after surgery protocol] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enhanced recovery protocols in Open Aortic surgeries |
|
Scientific Title of Study
|
A study to assess the efficacy of Enhanced Recovery After Surgery (ERAS) protocol in Open Abdominal Aortic Surgery - A Prospective, Randomized 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 |
Poornima P |
| Designation |
MCh vascular surgery resident |
| Affiliation |
Sri Jayadeva institute of cardiovascular sciences and research |
| Address |
Department of Vascular and Endovascular surgery
Sri Jayadeva institute of cardiovascular sciences and research
Jayanagar 9th block, Bengaluru
Bangalore KARNATAKA 560041 India |
| Phone |
7349669650 |
| Fax |
|
| Email |
purni.purni0609@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Poornima P |
| Designation |
MCh vascular surgery resident |
| Affiliation |
Sri Jayadeva institute of cardiovascular sciences and research |
| Address |
Dr Poornima P
Department of Vascular and Endovascular surgery
Sri Jayadeva institute of cardiovascular sciences and research
Jayanagar 9th block, Bengaluru No 78, Thirumurugan nagar, west Main Street, vadavalli, Maruthamalai main road, Coimbatore 641041
KARNATAKA 560041 India |
| Phone |
7349669650 |
| Fax |
|
| Email |
purni.purni0609@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Poornima P |
| Designation |
MCh vascular surgery resident |
| Affiliation |
Sri Jayadeva institute of cardiovascular sciences and research |
| Address |
Department of Vascular and Endovascular surgery
Sri Jayadeva institute of cardiovascular sciences and research
Jayanagar 9th block, Bengaluru
Bangalore KARNATAKA 560041 India |
| Phone |
7349669650 |
| Fax |
|
| Email |
purni.purni0609@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Vascular and Endovascular surgery, Sri Jayadeva Institute of Cardiovascular sciences and research
Jayanagar 9th Block,
Bannerghatta Road
Bangalore - 560 069
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sri Jayadeva Institute of Cardiovascular sciences and Research |
| Address |
Sri Jayadeva institue of Cardiovascular sciences and research, Jayanagar 9th Block,
Bannerghatta Road
Bangalore - 560 069
Karnataka, India |
| 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 Poornima P |
Sri Jayadeva Institute of Cardiovascular sciences and research |
Department of Vascular and Endovascular surgery, Jayanagar 9TH block,
Bannargetta main road,
Bangalore 560069
Karnataka Bangalore KARNATAKA |
7349669650
purni.purni0609@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Jayadeva Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I700||Atherosclerosis of aorta, (2) ICD-10 Condition: I714||Abdominal aortic aneurysm, withoutrupture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
Preoperative optimization of all comorbidities, Preoperative Counselling, Prophylactic IV antibiotics (2nd generation Cephalosporin)
, IV fluids post NPO status
(For diabetics modified accordingly) Alternated between 5%D and NS (from 12 hours prior to surgery), Intraoperative Narcotics and Paralytics as per Standard Anaesthesia Protocol, Sedatives as per Standard Anaesthesia Protocol, Use of SCD Intraoperatively,Postoperative Analgesics Inj. Paracetamol 1g IV Q8H, nj. Tramadol 50mg IV SOS Max Q8H, Tab. Ultracet PO TID When Pain Score more than 5, DVT Prophylaxis Only Pharmacological
Inj. Enoxaparin 40 to 60mg OD subcutaneous, Diet Advancement NPO on POD0 followed by variable dietary advancement based on Surgeon’s discretion based on bowel movement, NG Tube If Indicated, Foley’s Catheter to be removed once patient starts mobilizing out of bed., Abdominal Drain Removed when output less than 30ml. |
| Intervention |
ERAS group
(Duration of intervention Preoperative till discharge - no fixed time period) |
Preoperative optimization of all comorbidities,
Preoperative Counselling,
Prophylactic IV antibiotics (2nd generation Cephalosporin)
IV fluids post NPO status
(For diabetics modified accordingly), 5%D (Carbohydrate loading)
(from 12 hours prior to surgery), Additional Preoperative Medications - Tab. Gabapentin 300mg - Single Dose, Intraoperative TAP Block, Narcotic and paralytics
Minimal Dosage, Sedatives shortacting, Use of SCD Intraoperatively, Postoperative Analgesics Inj. Paracetamol 1g IV Q8H, Inj. Tramadol 50mg IV SOS Max Q8H, Tab. Ultracet PO TID When Pain Score more than 5, Diclofenac Suppository 50mg PR, Additional Medication Tab. Gabapentin 300mg PO BD POD1, DVT Prophylaxis Pharmacological and Mechanical
Inj. Enoxaparin 40-60mg OD subcutaneous, SCD, Postoperative Gum Chewing, Diet Advancement NPO for 6 hour post surgery followed by clear fluids at 30ml per hour
Liquid Diet from POD1 and soft diet from POD2 or earlier as per Surgeon’s discretion, NG Tube To be removed early if placed, Foley’s Catheter To be removed within 24 hours by encouraging the patient to mobilize, Abdominal Drain Removed when output less than 50ml.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with aortoiliac occlusive diseases or abdominal aortic aneurysms who are fit for surgery
Patients above the age of 18 years.
ASA grade between 1 to 3.
|
|
| ExclusionCriteria |
| Details |
Patients who required postoperative ICU admission.
Patients undergoing surgeries other than open abdominal aortic surgeries in the same sitting.
Patients requiring emergency surgery
Patients allergic to Bupivacaine
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean duration of Stay in Hospital (days)
|
Mean duration of Stay in Hospital (end point will be calculated on the day of discharge - which will be variable )
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain (using VAS) |
Numeric pain scoring at 6,12,24,36,48,72 hours |
Post-operative opioid consumption (in mg)
|
Total opiod consumption in mg at 12,24,36,48, 72 hours |
Mean time for conversion from IV analgesics to Oral analgesics (days)
|
days |
Mean time to first bowel movement (days)
|
How many days post op for bowel movement |
Mean time to return to liquid and regular diet (days)
|
hours |
Rate of 45 days readmission (in percentage)
|
Admission within 45 days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/02/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Enhanced Recover After Surgery (ERAS) pathways have gained
popularity in improving perioperative
outcomes. [1] They are
being implemented in various surgical specialities and have shown widespread success in colorectal surgeries. [2] They accelerate the
postoperative recovery thereby
bringing down the expenses and reducing the burden on the health care system
by efficient use of medical
resources.
Abdominal aortic surgeries are one of the commonly performed
surgeries by vascular surgeons. This could be due to aortoiliac occlusive
diseases which might require bypass surgery or due to pathologies such as
Aortic aneurysms which may require an intervention.
Open Abdominal Aortic surgeries can pose a challenge to the surgeons
based on the location, degree
of disease or calcified vessel, previous surgeries and abdominal compliance.
Though the surgeon does not have a control over these factors, there
are certain patient variables that are amenable for modifications that
can improve the perioperative outcome.
Based on the clinical and radiological findings, interventions for aortoiliac
occlusive diseases or aortic aneurysm diseases include bypass surgeries
involving Aortoiliacs or Open Abdominal Aortic aneurysm repair and minimally
invasive procedures such as Endovascular Aortic Aneurysm Repair (EVAR) or
Angioplasty and stenting depending on patient factor, disease factor,
comorbidities, et al. Endovascular procedures like EVAR offers many advantages
since it is minimal access surgery
but it is a costly procedure especially due to the use of stent graft systems,
hence they are not suitable for all
patients. Moreover, not all the patients will be having favourable anatomy for
EVAR. In patients who undergo open repair, the post-operative hospital
stay is longer and recovery is prolonged when
compared to EVAR
Open Abdominal Aortic surgery provides complexities not only during
surgery but also in perioperative management.
These group of patients commonly present with multiple comorbid conditions with
poor general state. Although multimodal pathways have been used in various
surgical disciplines, there are only
limited studies that directly apply ERAS protocols in Abdominal Aortic
surgery population. [3] Hence we decided to implement an ERAS
pathway for patients undergoing Open Abdominal Aortic surgery as it requires
longer duration of stay.
In this study the effect of ERAS pathway following Open
Abdominal Aortic surgery in terms of time to regular diet, time for bowel
movement and average duration of hospital stay following surgery will be
compared with a standard care protocol. Further
we will also be comparing
time to oral analgesics and readmission
rates. We hypothesised that patients for whom ERAS is implemented will have a faster
recovery time with better post-operative outcome and shortened hospital stay.
ERAS protocol will be implemented for eligible patients
undergoing open Abdominal Aortic surgery. The
purpose of in-hospital assessment, details of the procedure, and follow up assessment will be
explained clearly to the patient
or the family, as is appropriate.
|