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CTRI Number  CTRI/2025/01/079794 [Registered on: 30/01/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   The effect of enhanced recovery programs on older patients undergoing hip surgery - A Prospective Observational Study 
Scientific Title of Study   The impact of compliance with peri-operative ERAS components on postoperative outcomes in elderly population with hip fractures - A prospective observational study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  D Jeenu 
Designation  Assistant Professor 
Affiliation  christian medical college ,vellore 
Address  70 1D6 Ranipet housing campus, kannigapuram
Department of anaesthesia , christian medical college , vellore.
Vellore
TAMIL NADU
632004
India 
Phone  9597253114  
Fax    
Email  jeenudhanagopal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  D Jeenu 
Designation  Assistant Professor 
Affiliation  christian medical college ,vellore 
Address  Department of anaesthesia , christian medical college , vellore.
Department of anaesthesia , christian medical college , vellore.
Vellore
TAMIL NADU
632004
India 
Phone  9597253114  
Fax    
Email  jeenudhanagopal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  D Jeenu 
Designation  Assistant Professor 
Affiliation  christian medical college ,vellore 
Address  70 1D6 Ranipet housing campus, kannigapuram
Department of anaesthesia , christian medical college , vellore.
Vellore
TAMIL NADU
632004
India 
Phone  9597253114  
Fax    
Email  jeenudhanagopal@gmail.com  
 
Source of Monetary or Material Support  
Internal fluid research fund, Christian medical college, vellore 632004 
 
Primary Sponsor  
Name  Christian medical college 
Address  Christian medical college , vellore - 632004 
Type of Sponsor  Research institution and hospital 
 
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 Jeenu  Christian medical college  Department of anaesthesia , christian medical college , vellore.
Vellore
TAMIL NADU 
9597253114

jeenudhanagopal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics comitte,Institutional review board, christian medical college , vellore-632004  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Elderly patients above the age of 60 undergoing surgery for isolated hip fractures after recent trauma.
2. No previous surgeries on the same hip
 
 
ExclusionCriteria 
Details  1. No reliable historian/informant
2. Polytrauma
3. Revision surgery
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Length of hospital stay (in days)  5 days to 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Compliance with ERAS components - In Percentage
2. Time to surgery (Door to needle time) - In hours
3. Type of Anaesthesia - GA / Regional
4. Type of Surgery -
5. Incidence of postoperative complications -
Paralytic ileus - Y/N
Postoperative pulmonary complications - Y/N
Deep vein thrombosis (DVT)- Y/N
Acute kidney injury - Y/N
Acute blood loss causing anemia - Y/N
Cardiovascular complications - Y/N
Infections - Y/N
Postoperative cognitive decline - Y/N
Readmission to hospital/ED within 30 days - Y/N
6. Duration of ICU stay - in hours
7. Time to ambulate - in hours
8. Duration of hospital stay - in days
9. DASI Score on 30 day follow up in OPD - 0 -58.2 (Higher scores indicate higher functional status)
 
 
outcome will be assessed for a period of 30 days  5 days to 30 days 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   14/02/2025 
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)  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  

Hip fractures in the elderly are widely recognized to be one of the most morbid conditions in orthopedic surgery. Starting from pre-operative comorbid conditions, to intra operative issues faced by surgeons and anesthesiologists alike, to helping and optimizing conditions for a speedy recovery to premorbid status, the management of hip fractures in the elderly pose a challenge to any healthcare institution taking care of such cases. Many of the patients present with significant medical comorbid conditions, along with other factors like frailty, cognitive dysfunction etc. However, a multidisciplinary ERAS model (Enhanced Recovery After Surgery) is in use in many institutions around the world, to facilitate quick and effective optimization of the patient preoperatively, to ensure safe anesthetic practice, and to hasten the recovery process after surgery and minimizing postoperative complications. ERAS has been successfully used and extensively studied, especially in colorectal and abdominal surgery, and now is being implemented in orthopedic surgery as well. The implementation of such ERAS protocol is highly effective in shortening time to recovery, reducing hospital stay and improving postoperative quality of life in the long run. In this study, we analyze the compliance to internationally accepted components of ERAS for hip fractures in the elderly, to study the outcomes of hip fractures in the same group, and to find out the impact of compliance to ERAS on postoperative outcomes for the patient.

 

 
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