| CTRI Number |
CTRI/2025/10/096205 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
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Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
This study focuses on helping oral cancer patients recover faster using the Enhanced Recovery After Surgery (ERAS) program. ERAS features evidence-based practices like improved pre-surgery nutrition, shorter fasting, better pain management, and early movement and feeding post-surgery |
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Scientific Title of Study
|
Implementing ERAS protocol in oral cancer patients undergoing free flap reconstruction: an experimental prospecting study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.0 Dated 29/05/2025 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aseem Mishra |
| Designation |
professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi |
| Address |
Mahamana Pandit Madan Mohan Malviya Cancer Center, Varanasi
surgical oncology department
Flat 205 ND Sankalp, Saralabettu Manipal
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08080611946 |
| Fax |
|
| Email |
draseemmishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aseem Mishra |
| Designation |
professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi |
| Address |
Mahamana Pandit Madan Mohan Malviya Cancer Center, Varanasi
surgical oncology department
Flat 205 ND Sankalp, Saralabettu Manipal
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08080611946 |
| Fax |
|
| Email |
draseemmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suanayana sarkar |
| Designation |
professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi |
| Address |
Mahamana Pandit Madan Mohan Malviya Cancer Center, Varanasi
surgical oncology department
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drsunayanarsarkar@gmail.com |
|
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Source of Monetary or Material Support
|
| This study did not receive any financial or material support. It was self-funded by the investigators.
Study to be done in Mahamana Pandit Madan Mohan Malviya Cancer center, Varanasi Uttar Pradesh,
pin code: 221005 India
|
|
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Primary Sponsor
|
| Name |
Dr Aseem Mishra |
| Address |
Mahamana Pandit Madan Mohan Malviya Cancer Center Varanasi UTTAR PRADESH
PINCODE 221005
INDIA |
| Type of Sponsor |
Other [SELF ] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aseem Mishra |
Mahamana Pandit Madan Mohan Malviya Cancer Center, Varanasi Uttar pradesh pincode 221005, India |
opd no 12, 13, 26 DEPARTMENT of head and neck oncology
Varanasi
UTTAR PRADESH |
08080611946
draseemmishra@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahamana pandit madan mohan malviya cancer center and homibhama cancer center |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
experimental prospective cohort study |
• Preoperative Assessment:
o Baseline demographic data: Age, sex, BMI, smoking status, alcohol use.
o Oral Cancer Staging: Record the T, N, and M stages using the AJCC TNM system.
o Preoperative nutritional assessment (MUST score).
o Preoperative pain score (e.g., Visual Analog Scale [VAS]).
o Psychological assessment, if applicable (anxiety levels, depression screening).
• Intraoperative Data:
o Surgical details: Type of flap, surgical time, blood loss.
o Anaesthesia technique used (e.g., multimodal analgesia, regional anaesthesia, type of anaesthesia).
• Postoperative Data:
o Pain scores (using VAS or Numeric Rating Scale [NRS]) at 24-, 48-, and 72-hours post-surgery.
o Opioid consumption (morphine equivalents) within the first 72 hours post-surgery.
o Length of hospital stay.
o Postoperative complications (e.g., flap failure, infection, wound healing).
o Mobilization milestones (e.g., able to sit up, walk, and discharge criteria).
o Nutritional intake and need for supplemental nutrition.
o Readmission rates within 30 days
4) Follow-Up:
• Patients will be followed up at:
o 1 week: Clinical check for flap viability, wound healing, and complications.
o 1 month: Assessment of functional recovery (e.g., speech, swallowing, nutrition).
o 3 months: Evaluation of long-term recovery, recurrence, and psychosocial impact.
5) Data Collection Methods:
• Patient surveys to measure patient satisfaction, pain levels, and perceived quality of recovery.
• Medical records review for complications, LOS, and postoperative management.
• Clinical assessments: Swallowing function (using standard scales), speech therapy assessment, and physical therapy notes.
|
| Comparator Agent |
non eras group |
Group B – Traditional Care Group
Patients undergoing oral cancer resection and free flap reconstruction managed with conventional perioperative care as per existing institutional protocol.
Standard postoperative care involving conventional analgesia (opioid-based), delayed oral intake, standard mobilization timeline, and routine perioperative fluid management. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients diagnosed with oral cavity cancer requiring free flap reconstruction as part of surgical management.
Patients undergoing primary surgical resection and immediate reconstruction using microvascular free flap (e.g., radial forearm, fibula, or anterolateral thigh flap).
Patients who are clinically fit for major surgery under general anesthesia.
Patients willing to participate and provide written informed consent for inclusion in the study. |
|
| ExclusionCriteria |
| Details |
o Patients with a history of previous major reconstructive surgery of the oral cavity.
o Patients with severe comorbidities (e.g., advanced heart failure, chronic renal failure, uncontrolled diabetes) that would significantly impact surgical or recovery outcomes.
o Pregnancy or lactating women.
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay (LOS) |
o 1 week: Clinical check for flap viability, wound healing, and complications.
o 1 month: Assessment of functional recovery (e.g., speech, swallowing, nutrition).
o 3 months: Evaluation of long-term recovery, recurrence, and psychosocial impact.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
• Postoperative complications (e.g., flap failure, wound infection, sepsis, pneumonia).
• Pain scores postoperatively, with a focus on the reduction in opioid use ().
• Functional recovery outcomes such as speech, swallowing, & mobility.
• Patient satisfaction: Assessed using validated questionnaires (e.g., EQ-5D, PROMIS).
• Nutritional status: Preoperative vs. postoperative (tracked via serum albumin, weight changes, & dietary intake).
|
o 1 week: Clinical check for flap viability, wound healing, & complications.
o 1 month: Assessment of functional recovery (e.g., speech, swallowing, nutrition).
o 3 months: Evaluation of long-term recovery, recurrence, & psychosocial impact.
|
|
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Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/10/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This prospective observational cohort study aims to evaluate the impact of the Enhanced Recovery After Surgery (ERAS) protocol on postoperative outcomes in patients undergoing oral cancer reconstruction using free flap surgery at Tata Memorial Hospital, Varanasi. The ERAS protocol is a multidisciplinary, evidence-based approach designed to optimize perioperative care and promote faster recovery. Although it has shown benefits in various surgical specialties, its application in oral cancer reconstruction remains limited. The study will include 196 patients (98 in the ERAS group and 98 in the traditional care group) and will assess outcomes such as length of hospital stay (primary outcome), postoperative complications, pain control, opioid consumption, nutritional and functional recovery, and patient satisfaction. Cancer staging (TNM classification) will also be analyzed to determine its influence on recovery outcomes. By systematically implementing and evaluating the ERAS protocol, this study aims to enhance recovery, reduce complications, and improve overall patient satisfaction following major head and neck reconstructive surgery. |