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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  
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 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  
Status 
Not Applicable 
 
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.

 

 
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