| 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
|
|
|
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
|
|
|
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.
|