| CTRI Number |
CTRI/2024/07/071183 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Preoperative, Intraoperative, Postoperative care changes] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of ERAS on duration of hospital stay in patients undergoing surgery for oral cancers. |
|
Scientific Title of Study
|
Effect of Enhanced Recovery After Surgery on Length of hospital stay among patients undergoing surgery for Oral cancers- A Randomized Controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharanipradab M |
| Designation |
Senior Resident |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of surgical oncology,Super speciality block, Jawaharlal Institute of Postgraduate Medical Education & Research.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8838169289 |
| Fax |
|
| Email |
mayadharani19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balasubramanian A |
| Designation |
Professor and Head |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Surgical Oncology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9445216149 |
| Fax |
|
| Email |
drbalasubram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balasubramanian A |
| Designation |
Professor and Head |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Surgical Oncology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9445216149 |
| Fax |
|
| Email |
drbalasubram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education & Research, JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.India. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Dharanipradab M |
Jawaharlal Institute of Postgraduate Medical Education & Research |
Department of surgical oncology, Superspeciality block, Jawaharlal Institute of Postgraduate Medical Education & Research,Dhanwantari Nagar, Puducherry. 605006
Pondicherry
PONDICHERRY |
8838169289
mayadharani19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES (JIP/IEC/2024/04/48) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS group |
Patients with Oral cancers undergoing surgery received ERAS based Preoperative, Intraoperative and Postoperative care will assessed for 30 days after surgery. |
| Intervention |
Non ERAS group |
Patients with Oral cancers undergoing surgery received routine standard Preoperative, Intraoperative and Postoperative care will be assessed for 30days after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult Population aged 18 years and above
2)Diagnosed case of Oral cancers undergoing surgery
3)ECOG Performance Status of 0 to 2 |
|
| ExclusionCriteria |
| Details |
1. Free Osteocutaneous flaps taken from lower limbs.
2. Use of multiple (2 and above) regional/distant flaps and central Mandibulectomy
3. Post radiation therapy
4. Salvage surgery for residual/recurrent disease
5. Patients with Renal and Liver decompensation
6. Not consenting for the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of ERAS on LOS among the patients with Oral cancers undergoing surgery |
Duration of total hospital stay will assessed at 30 days after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the mean ICU stay, morbidity & mortality & 30-day readmission rate |
Outcomes will be assessed till postoperative day 30 |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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 |
|
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
|
Introduction: ERAS pathways include evidence-based measures designed to reduce perioperative stress, maintain postoperative physiological function and accelerate recovery after surgical intervention. Using this multimodal stress minimizing approach it has been proven repeatedly to reduce the morbidity by 40%, length of hospital stay (LOS) and improve recovery after colorectal surgery.Oral cancers is one of the most common cancers in the Indian subcontinent and surgery is an integral part of treatment and that enormous prevalence along with the morbidity of surgery amounts to a huge burden on our healthcare system. Though there are many studies evaluating the effect of ERAS in reducing LOS after surgery in Oral cancers, they are limited in terms of the cases studied, having retrospective analysis and inclusion of only a particular subgroup of patients. In this study, we expect to find the effect of ERAS in reducing LOS among patients with Oral cancers undergoing surgery by the specified perioperative and postoperative interventions as per ERAS as an adjunct to the standard of care that may reduce the LOS and reduce the postsurgical complications. Aim and Objectives: Primary -To assess the effect of ERAS on LOS among the patients with Oral cancers undergoing surgery Secondary - To compare the mean ICU stay, morbidity and mortality and 30-day readmission rate Methods: In this RCT we will include patients who are all meeting the inclusion and exclusion criteria with oral cancers and after randomization they be divided into intervention and control arm. The intervention arm will receive ERAS care (With prespecified preoperative, intraoperative, postoperative measures) in addition to the standard perioperative care, and the control arm will receive standard perioperative care. After that study population will be followed prospectively and will be assessed for the primary and secondary objectives. |