| CTRI Number |
CTRI/2022/09/045750 [Registered on: 21/09/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Adherence patterns to ERAS and its association with treatment outcomes in Oral Cavity Squamous Cell Carcinoma. |
|
Scientific Title of Study
|
Adherence patterns to Enhanced Recovery After Surgery[ERAS] protocol and its association with the treatment outcomes among the patients with Oral Cavity Squamous Cell Carcinoma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aman Prakash |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Dept . Of Surgical Oncology,
3rd Floor SSB,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7278625446 |
| Fax |
|
| Email |
amansog2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Balasubramanian |
| Designation |
Professor (Dept. of surgical Oncology) |
| Affiliation |
JIPMER |
| Address |
Dept . Of Surgical Oncology,
3rd Floor SSB,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9445216149 |
| Fax |
|
| Email |
drbalasubram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aman Prakash |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Dept . Of Surgical Oncology,
3rd Floor SSB,
JIPMER
PONDICHERRY
605006
India |
| Phone |
7278625446 |
| Fax |
|
| Email |
amansog2022@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Aman Prakash |
JIPMER |
Dept . Of Surgical Oncology,
3rd Floor SSB, JIPMER
JIPMER Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
7278625446
amansog2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: C000||Malignant neoplasm of external upper lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enhanced recovery after surgery (ERAS) |
Enhanced recovery after surgery (ERAS) is a multidisciplinary approach consisting of perioperative and operative management aiming at improving clinical outcomes including :
Preoperative
1.Education regarding
Counseling for de-addiction from tobacco and its related products - smoking, pan masala, quid etc for a minimum period of 4 weeks, the extent of surgery and treatment, hospital course, recovery and outcomes
2. Speech consultation and rehabilitation
3. Nutrition assessment and rehabilitation.
4. Oral and dental hygiene - with 0.2 % Chlorhexidine Mouthwash and adequate dental care.
5. Nausea prophylaxis – With oral prokinetic drugs a day before OT (Tab metoclopramide 10 mg at HS)
6. Carbohydrate rich beverage (50gm of glucose in 200 ml of water) up to 2 hours prior OT
7. Multimodal analgesia – Non opioid analgesia (NSAIDs, acetaminophen, and gabapentin) with limited use of opioids
8. Antibiotics – 1 hour before incision and to be repeated if surgery is prolonged for more than 4 hours with 24-hour antibiotic prophylaxis covering oral flora is indicated for clean-contaminated procedures.
9. Tracheostomy planning during preoperative assessment
10. Short-acting anxiolytics – non opioid anxiolytic (short-acting oral - Tab Alprazolam 0.25mg at HS and intravenous anxiolytic - Inj MIdazolam 0.05mg/kg before induction)
Intraoperative
1. Goal directed Fluid therapy - Net zero fluid balance is supported for early recovery and to minimize postoperative flap complications.
Maintenance of Normothermia
2. Adequate Vasopressors
Blood transfusion only when required
Postoperative
1. Nursing
a. ICU care
b. Flap monitoring
2. Multimodal analgesia - non opioid analgesia.
3. Nasogastric tube feeds POD - within 24 hours of surgery
Early mobilization within 24 hours of surgery
4. Speech and nutrition consultation
Early Catheter removal - within 24-48 hours (after mobilization)
4. Early tracheostomy decannulation, if done - Early tracheostomy decannulation will be initiated within 48 hours with criteria for decannulation if the patient can tolerate corking without respiratory distress for 24 hours. The goal is to discharge patients without a tracheostomy.
5. Oral feeding - within 7-10 days depending upon the resected structures.
6. Early Nasogastric tube removal with initiation of and continuation of adequate oral diet
7. Blood transfusion if Hb 8 g/dl
8. Early discharge based on set criteria –
a. Stable vitals.
b. Satisfactory wound healing - Southampton Score equal or less than 2
c. No significant symptoms - fever, vomiting and respiratory distress.
d. Pain - less than 5 on scale of 0 to 10 or if Pain can be controlled on Oral analgesics.
e. No other complication requiring hospital stay
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult Population age between 18 years to 70 years
2. Diagnosed case of Oral cavity squamous cell carcinoma undergoing surgery
3. ECOG Performance Status of 0 to 2
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Adherence patterns to Enhanced Recovery After Surgery protocol.
2. Association of the adherence patterns to Enhanced Recovery After Surgery protocol with the postsurgical outcomes among the patients with Oral Cavity Squamous Cell Carcinoma undergoing surgery. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| length of hospital stay, mean ICU stay, 30-day readmission rate, morbidity and mortality with historical controls (pre ERAS era). |
30 days |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/09/2022 |
| Date of Study Completion (India) |
31/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/10/2023 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
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
|
Enhanced recovery after surgery (ERAS) is a multidisciplinary approach consisting of perioperative and operative management aiming at improving clinical outcomes. This is achieved through principles such as patient education, goal-directed fluid therapy, multimodal analgesia, and early mobilization with help of a team consisting of nurses, anesthesiologists, dieticians, physical specialists, social workers and surgeons.
Oral cancer with a 5-year prevalence of more than 3 lakh is one of the most common cancers in the Indian subcontinent. Surgery is an integral part of treatment and that enormous prevalence along with morbidity of surgery amounts to a huge burden on our Health care system. Advantages of Enhanced recovery after surgery (ERAS) has been proven in multiple fields such as colorectal surgery, hepatobiliary surgery, and thoracic surgery with factors such as reduced complication rates and shorter hospital length of stay (LOS).
Novelty: Though there are studies evaluating the effect of Enhanced Recovery After Surgery in Oral Oncosurgery, they are limited in terms of the cases studied, having retrospective analysis and inclusion of only a particular subgroup of patients.
Expected Outcomes: In this study, we expect to find adherence and response of ERAS in patients with Oral cavity carcinoma undergoing surgery by the specified perioperative and operative intervention as an adjunct to the standard of care that may reduce the hospital stay and reduce the complications.
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