| CTRI Number |
CTRI/2023/03/050369 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check the adherence of Enhanced Recovery After Surgery ( ERAS) guidelines with our existing institutional practice for Head and Neck Cancer patients undergoing Free Flap Surgery |
|
Scientific Title of Study
|
Compliance of existing institutional practice with ERAS protocol in patients with Head-Neck cancer undergoing free flap reconstruction surgery: A prospective cohort study |
| Trial Acronym |
CERAH FLARES |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyotsna Goswami |
| Designation |
Senior Consultant and HOD |
| Affiliation |
Tata Medical Center |
| Address |
TC 1004, Tata Avenida, Plot No IIG/7, Newtown, AA II, Kolkata
14 Major Arterial Road(E-W),DH Block(NewTown), Action Area I, New Town, 700160
Kolkata
WEST BENGAL
700160
India |
| Phone |
9830327187 |
| Fax |
|
| Email |
jyotsnagoswami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Goswami |
| Designation |
Senior Consultant and HOD |
| Affiliation |
Tata Medical Center |
| Address |
TC 1004, Tata Avenida, Plot No IIG/7, Newtown, AA II, Kolkata
14 Major Arterial Road(E-W),DH Block(NewTown), Action Area I, New Town, 700160
Kolkata
WEST BENGAL
700160
India |
| Phone |
9830327187 |
| Fax |
|
| Email |
jyotsnagoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotsna Goswami |
| Designation |
Senior Consultant and HOD |
| Affiliation |
Tata Medical Center |
| Address |
TC 1004, Tata Avenida, Plot No IIG/7, Newtown, AA II, Kolkata
14 Major Arterial Road(E-W),DH Block(NewTown), Action Area I, New Town, 700160
Kolkata
WEST BENGAL
700160
India |
| Phone |
9830327187 |
| Fax |
|
| Email |
jyotsnagoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
no sponsor |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
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 Jyotsna Goswami |
Tata Medical Center |
14, Major Arterial Road ( E-W), Action Area I; New Town, Rajarhat, Kolkata
Kolkata
WEST BENGAL |
9830327187
jyotsnagoswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center- Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I to III
2. No obvious distant metastasis on CT |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Prior history of head and neck surgery
3. Other organ resection during the surgery
4. Psychiatric conditions which could make communication difficult |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage Compliance of existing institutional practice with ERAS protocol in head and neck patients undergoing free flap surgeries |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Complications over a period of 30 days classified according to Clavien Dindo Classification
2. Length of hospital stay
3. Length of ICU stay
4. Surgical re- exploration and negative re-exploration rates |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="146" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2023 |
| Date of Study Completion (India) |
31/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Head and neck malignancies require major free flap reconstruction surgeries to correct deformities and restore function. Optimal perioperative care is required for best possible recovery in this subset of patients. In this regard it has been established ERAS guidelines implementation decreases postoperative morbidity. In this prospective single center cohort study we have aimed to evaluate compliance percentage of the existing institutional practice with ERAS protocol in head and neck cancer patients undergoing free flap reconstruction surgery and to study the association between rates of ERAS compliance and post operative outcomes. Compliance with the ERAS variables will be measured for each component of the program as enlisted by the ERAS society recommendations specific for free flap surgeries. Overall compliance will be calculated as the percentage of ERAS elements that are being fulfilled for each patient individually as well as for the entire cohort The patients will then be divided into 2 groups according to their degree of compliance with the ERAS interventions. The patients who comply with 75% or more items will be allocated to the ERAS-Compliant group and those who comply with less than 75% of the ERAS components will be allocated to the ERAS- Noncompliant group. Complications reported within 30 days of surgery will be classified according to Clavien Dindo classification. The length of stay will be defined as the number of days patient spent in the hospital after surgery. Length of critical care unit stay will be defined as number of days patient stayed in the Intensive Care Unit and High Dependancy Unit after surgery. Surgical outcome measures will include re-exploration rates and negative re-exploration rates |