| CTRI Number |
CTRI/2025/01/078991 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Randomized control trial comparing Improved Recovery Program for Facial Bone Fractures and the traditional approach in a tertiary care hospital |
|
Scientific Title of Study
|
Enhanced Recovery After Surgery (ERAS) Protocol in Faciomaxillary Fractures at a Tertiary Care Hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Omkar Gutta |
| Designation |
MCh Resident in Department of Plastic Surgery |
| Affiliation |
St. Johns National Academy of Health Sciences |
| Address |
St. Johns National Academy of Health Sciences.Sarjapur Road, Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9307646514 |
| Fax |
|
| Email |
gutta.omkar@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abha Rani Kujur |
| Designation |
MCh Plastic Surgery |
| Affiliation |
St. Johns National Academy of Health Sciences |
| Address |
St. Johns National Academy of Health Sciences.Sarjapur Road, Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9980906422 |
| Fax |
|
| Email |
dr.abhakujur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abha Rani Kujur |
| Designation |
MCh Plastic Surgery |
| Affiliation |
St. Johns National Academy of Health Sciences |
| Address |
St. Johns National Academy of Health Sciences.Sarjapur Road, Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9980906422 |
| Fax |
|
| Email |
dr.abhakujur@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Johns National Academy of Health Sciences
Sarjapur Road, Bangalore - 560034,
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Omkar Gutta |
| Address |
St. Johns National Academy of Health Sciences
Sarjapur Road, Bangalore - 560034,
Karnataka, India. |
| Type of Sponsor |
Other [SELF ] |
|
|
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 Omkar Gutta |
St. Johns National Academy of Health Sciences |
Department of Plastic and Reconstructive Surgery. Room No 26. OPD building. Gate 1.
Bangalore
KARNATAKA |
9307646514
gutta.omkar@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of St.Johns National Academy of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S028||Fractures of other specified skulland facial bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preoperative 200ml of carbohydrate drink, Injection Tranexamic acid 1gm, Injection Dexamethasone 8mg. |
Preoperative carbohydrate loading 2 hours before the surgery attenuates insulin resistance and catabolism. Promotes better glucose control and lean tissue preservation.
Injection Tranexamic acid 1gm at the time of anesthesia induction can reduce the amount of blood loss during the surgery of faciomaxillary fracture fixation.
Injection Dexamethasone 8mg at the time of anesthesia induction to tackle the postoperative pain and tissue edema which will further reflect the duration of stay in the hospital. |
| Comparator Agent |
Traditional hospital protocol |
Standard perioperative care practices without the integration of ERAS guidelines. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have sustained Faciomaxillary fractures from any cause.
Patients undergoing surgical intervention for faciomaxillary fractures.
Patients with TBI with GCS 15/15 at the time of surgery. |
|
| ExclusionCriteria |
| Details |
Patients with fractures other than faciomaxillary fractures
Patients with nasal bone fractures
Patients with traumatic brain injury with GCS less than 15/15
Patients with injuries other than faciomaxillary fractures which might require immobilization and prolonged hospital stay.
Patients with comorbidities(eg.Diabetes, Hypertension, thyroid disease and chronic disease) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To formulate an Enhanced Recovery After Surgery (ERAS) protocol specifically tailored for patients with Faciomaxillary fractures in a tertiary care hospital setting |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total duration of patient in the hospital from the time of admission till the discharge |
2 years |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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) |
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
|
ERAS protocols are well-established across various surgical fields but under-researched in faciomaxillary surgery. These fractures, affecting critical functions like breathing, eating, and speaking, require specialized care. - Enhanced Recovery: ERAS can accelerate recovery for faciomaxillary fracture patients.
- Reduced Complications: Goal-directed fluid therapy and net-zero fluid balance minimize edema and fluid overload, crucial for faciomaxillary surgery.
- Improved Outcomes: Standardized perioperative care improves patient outcomes, reduces hospital stays, and enhances postoperative quality of life.
- Literature Gap: This study addresses the need for focused research on ERAS in faciomaxillary surgery to validate its benefits and establish best practices.
This study aims to develop and evaluate a tailored ERAS protocol for faciomaxillary fracture patients, assessing improvements in clinical outcomes and recovery. |