| CTRI Number |
CTRI/2025/03/083212 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Patient Satisfaction Scores and incidence of perioperative complications with adherence to Enhanced Recovery after Surgery (ERAS) protocol in Total Knee replacement surgery in Indian population: A prospective observational Study |
|
Scientific Title of Study
|
Evaluation of perioperative outcomes and Patient Satisfaction Scores after adherence to a standardised Enhanced Recovery after Surgery (ERAS) protocol in Total Knee replacement surgeries in Indian population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Damarla Haritha |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Medical College |
| Address |
Operation theatre, 2nd floor, Narayana General Hospital, Chintareddypalem
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8096455970 |
| Fax |
|
| Email |
damarlaharitha007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Damarla Haritha |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Medical College |
| Address |
Operation theatre, 2nd floor, Narayana General Hospital, Chintareddypalem
ANDHRA PRADESH
524003
India |
| Phone |
8096455970 |
| Fax |
|
| Email |
damarlaharitha007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Damarla Haritha |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Medical College |
| Address |
Operation theatre, 2nd floor, Narayana General Hospital, Chintareddypalem
ANDHRA PRADESH
524003
India |
| Phone |
8096455970 |
| Fax |
|
| Email |
damarlaharitha007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Narayana Medcial College |
| Address |
Narayana Medical College, Chintareddypalem, Nellore, Andhra Pradesh. PIN: 524003 |
| 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 Damarla Haritha |
2nd floor, Operation theatre complex, Narayana Medical College |
Chintareddypalem, Nellore, PIN: 524003
Nellore
ANDHRA PRADESH |
8096455970
damarlaharitha007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS grade I or II, posted for knee replacement, ability to complete modified EVAN - G score |
|
| ExclusionCriteria |
| Details |
Refusal to participate, ASAPS grade more than IV, Patients expected to land up in ICU in the postoperative period, Surgery scheduled on a semi emergency (time sensitive) basis, inability to comprehend the EVAN – G score even with the help of a translator
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the incidence of Numerical Rating Scale at rest and motion, motor weakness, ability to perform physiotherapy, postoperative pulmonary complications, anemia, blood transfusions, Postoperative nausea and vomiting, Urinary retention,.Ileus, Shivering, Wound infection, re-exploration, secondary suturing, Deep Vein Thrombosis, Duration of hospital stay
|
at the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To estimate patient satisfaction score after following a protocolized approach for perioperative management of knee replacement surgeries |
At discharge |
|
|
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)
|
31/03/2025 |
| 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="2"
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
|
50 patients undergoing total knee replacement electively will be recruited in the above mentioned prospective observational study after fulfilling the inclusion and exclusion criteria. all the components of the ERAS protocol will be strictly followed as mentioned and the incidence of postoperative complications and patient satisfaction at the end of hospital stay will be noted. It has been noted that following ERAS protocol strictly reduces perioperative complications. We would like to observe if such protocols can be followed in middle income countries like India and if it reduces postoperative complications. |