| CTRI Number |
CTRI/2024/02/062799 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE HOSPITAL BASED |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study of impact of peri-operative anaesthetic management on early recovery after surgery (ERAS) for hepatic resections. |
|
Scientific Title of Study
|
Clinical study of impact of peri-operative anaesthetic management on early recovery after surgery (ERAS) for hepatic resections in a tertiary care hospital |
| Trial Acronym |
ERAS protocol for hepatic resection |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR TANUJ SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
| Address |
RIICO Institutional Area,Sitapura,
Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA
Jaipur RAJASTHAN 302022 India |
| Phone |
9983505040 |
| Fax |
|
| Email |
DRTANUJSHARMA@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
DR AVNISH KUMAR BHARADWAJ |
| Designation |
PROFESSOR & HEAD OF THE DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
| Address |
RIICO Institutional Area,Sitapura,
Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA
Jaipur RAJASTHAN 302022 India |
| Phone |
9314882845 |
| Fax |
|
| Email |
AVNISHBHARADWAJ1@GMAIL.COM |
|
Details of Contact Person Public Query
|
| Name |
DR AVNISH KUMAR BHARADWAJ |
| Designation |
PROFESSOR & HEAD OF THE DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
| Address |
RIICO Institutional Area,Sitapura,
Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA
Jaipur RAJASTHAN 302022 India |
| Phone |
9314882845 |
| Fax |
|
| Email |
AVNISHBHARADWAJ1@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL Jaipur |
|
|
Primary Sponsor
|
| Name |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
| Address |
RIICO Institutional Area,Sitapura,
Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA |
| Type of Sponsor |
Private 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 TANUJ SHARMA |
OT complex and ICU MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
RIICO Institutional Area,Sitapura,
Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA Jaipur RAJASTHAN |
9983505040
DRTANUJSHARMA@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RAJENDRA KUMAR SUREKHA, MEMBER SECRETARY IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arterial line |
Arterial line for intraoperative beat to beat monitoring. |
| Intervention |
Epidural catheter |
Placement of epidural catheter for post operative analgesia. |
| Intervention |
Internal jugular vein catheterization |
IJV catheterization is done for goal directed fluid therapy and to monitor CVP. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with American Society of anesthesiologists (ASA) Class I, II and III.
Patient posted for elective hepatectomy.
Invasive procedures: -
Epidural analgesia.
CVP monitoring via central line.
MAP monitoring via arterial line. |
|
| ExclusionCriteria |
| Details |
BMI over 30
Uncontrolled comorbidities viz diabetes, hypothyroidism, hypertension, etc.
History of cerebrovascular accident.
Patient with known or newly diagnosed coagulopathy.
Pregnant patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Days of stay in hospital.
Early recovery after surgery. |
Days of stay in hospital.
Early recovery after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction of received care.
Reduce number of complications.
Re-intervention and re-admission rates.
Health related quality of life and physical activity of patients. |
Aims to accelerate patient recovery through creating a structured approach with defined components of care at each perioperative stage |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
25/02/2024 |
| 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="6" 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 - NO
|
|
Brief Summary
|
Enhanced recovery after surgery (ERAS): FAST TRACK SURGERY conceptualized by Prof. Henrik kehlet in order to early mobilization and recovery after surgery. ERAS concept gained considerable momentum globally. Enhanced recovery after surgery (ERAS) is an evidence-based approach to surgical care aimed at minimizing the stress of surgery and supporting patients to recover quickly through maintenance of normal physiology. ERAS protocol for hepatic resection pathway have been found to be safe and effective in patient undergoing liver resection, resulting in shortened postoperative stay, reduces mortality, re-admission rates and reduced costs. Aims to accelerate patient recovery through creating a structured approach with defined components of care at each perioperative stage (pre-, intra-, and post-).The key elements of ERAS include patient/family education, patient optimization prior to admission, minimal fasting that includes a carbohydrate beverage two hours before anesthesia, multimodal analgesia with appropriate use of opioids when indicated, return to normal diet and activities the day of surgery, and return of bowel function early.
A prospective, hospital based, observational study including all cases of liver resection in a time period between April 2023 to October 2024.
Data will be collected by using self design questionnaire.
Entire data would be entered into a Microsoft office software and appropriate statistical test will be applied and results will be calculated. |