| CTRI Number |
CTRI/2025/07/090918 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Components of ERAS |
|
Scientific Title of Study
|
Components of non compliance to ERAS in curative surgery for gastrointestinal and gynaecological cancer- A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja |
| Designation |
Senior resident |
| Affiliation |
|
| Address |
Ground floor, Department of surgical oncology,Aiims Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9996218768 |
| Fax |
|
| Email |
pooja.khandelwal77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dillip Muduly |
| Designation |
Professor and Head of Department |
| Affiliation |
Aiims Bhubaneswar |
| Address |
Ground floor, Department of surgical oncology,Aiims Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9013072969 |
| Fax |
|
| Email |
dillipmuduly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dillip Muduly |
| Designation |
Professor and Head of Department |
| Affiliation |
Aiims Bhubaneswar |
| Address |
Ground floor, Department of surgical oncology,Aiims Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9013072969 |
| Fax |
|
| Email |
dillipmuduly@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ground floor, Department of surgical oncology,Aiims Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Aiims Bhubaneswar |
| Address |
Department of surgical oncology,Aiims Bhubaneswar, Khordha Odisha, 751019 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Pooja |
Surgical oncology |
Dr Pooja, AIIMS bbsr
Khordha
ORISSA |
09996218768
pooja.khandelwal77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims bhubneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
observational |
observational |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Gastrointestinal and gynaecological cancer,
2 willingness
3 willingness to follow up
4 curative surgery |
|
| ExclusionCriteria |
| Details |
1 Extremes of age
2 non consent for participation or follow up
3 poor performance score |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| non compliance to ERAS protocol |
2weeks, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of post operative stay, complicatoions, Reoperativion & readmission rate |
3 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
31/07/2025 |
| 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="1"
Months="5"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Identification of common areas of non-compliance helps prioritize targeted staff and patient education, improving ERAS adherence.Improves patient outcomes by modifying perioperative practices where non-compliance is linked to increased complications or prolonged LOS. Facilitates protocol adaptation specific to cancer surgery patients (e.g., stoma patients, elderly with frailty), making ERAS more practical in real-world oncology settings.Data-driven quality improvement for institutional ERAS audits and QI cycles.Supports enhanced resource utilization by reducing unnecessary delays in recovery, discharge, and adjuvant therapy initiation.Improves patient satisfaction by identifying and addressing barriers (e.g., pain control, nausea) leading to non-compliance.Contributes to evidence generation for ERAS in low-middle income settings, addressing resource and patient population-specific barriers.
|