| CTRI Number |
CTRI/2024/12/077848 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Fast-track Surgery protocols in Gynaecologic Oncology- A feasibility study |
|
Scientific Title of Study
|
Enhanced Recovery After Surgery (ERAS) in Gynaecologic Oncology- A feasibility 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 |
Karen K |
| Designation |
MCH trainee |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Gynaecologic Oncology, Christian Medical College, CMC main campus, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9952614813 |
| Fax |
|
| Email |
karenkanagasabapathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinotha Thomas |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Gynaecologic Oncology, Christian Medical College, CMC main campus, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9944141505 |
| Fax |
|
| Email |
thomasvinotha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karen K |
| Designation |
MCH trainee |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Gynaecologic Oncology, Christian Medical College, CMC main campus, Vellore.
TAMIL NADU
632004
India |
| Phone |
9952614813 |
| Fax |
|
| Email |
karenkanagasabapathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional fluid grant, Christian Medical College, Vellore, Tamil Nadu, India- 632004 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College, Vellore |
| Address |
Christian Medical College, Vellore, 632004. |
| Type of Sponsor |
Private 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 |
| Dr Karen K |
Christian Medical College |
Room number 1, Department of Gynaecologic Oncology, ISSCC building 7th floor.
Vellore
TAMIL NADU |
9952614813
karenkanagasabapathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD CHRISTIAN MEDICAL COLLEGE THORAPADI POST BAGAYAM VELLORE Vellore Tamil Nadu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51||Malignant neoplasm of vulva, (2) ICD-10 Condition: C52||Malignant neoplasm of vagina, (3) ICD-10 Condition: C53||Malignant neoplasm of cervix uteri, (4) ICD-10 Condition: C54||Malignant neoplasm of corpus uteri, (5) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (6) ICD-10 Condition: C56||Malignant neoplasm of ovary, (7) ICD-10 Condition: C57||Malignant neoplasm of other and unspecified female genital organs, (8) ICD-10 Condition: C58||Malignant neoplasm of placenta, (9) ICD-10 Condition: D06||Carcinoma in situ of cervix uteri, (10) ICD-10 Condition: D07||Carcinoma in situ of other and unspecified genital organs, (11) ICD-10 Condition: D28||Benign neoplasm of other and unspecified female genital organs, (12) ICD-10 Condition: D27||Benign neoplasm of ovary, (13) ICD-10 Condition: D25||Leiomyoma of uterus, (14) ICD-10 Condition: D26||Other benign neoplasms of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
All patients diagnosed with malignancies and pre-invasive disease of the female genital tract (endometrium, ovary, peritoneum, fallopian tube and cervix) undergoing surgery. |
|
| ExclusionCriteria |
| Details |
Benign disease; surgery done on emergency basis; ASA 3-4 (American Society of Anesthesiologists physical status classification status) |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the compliance to implementing ERAS recommendations by ERAS society for patients with gynaecologic malignancies undergoing surgery |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A) To evaluate the compliance rate to individual ERAS protocols
B) To assess post-operative morbidity using Clavien-Dindo classification |
1 year |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
15/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
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
|
Enhanced recovery after surgery initially termed as "fast track recovery" was first implemented in the 1990s in patients undergoing cardiopulmonary bypass and they found this method to be effective. However, the initial version of ERAS protocols in Gynaecologic oncology were published only in 2016 and the same was updated in 2019. The execution of ERAS recommendations results in reduction in post-operative metabolic stress and complications in addition to reduced hospital stay and cost. Though the protocols have shown clearcut benefits it requires multidisciplinary systematic approach in the per-operative care. |