| CTRI Number |
CTRI/2025/09/094107 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting Recovery in Older Adults Undergoing Cancer Surgery: Insights from a New Scoring Tool (G8) |
|
Scientific Title of Study
|
Outcome analysis of geriatric patients undergoing major abdominal cancer surgeries using G8 scoring: a prospective observational study in a tertiary cancer centre in eastern India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEBARTHA BANDYOPADHYAY |
| Designation |
SPECIALIST GRADE2 |
| Affiliation |
Chittaranjan National Cancer Institute |
| Address |
Chittaranjan National Cancer Institute, 2nd campus- Street no. 299, Plot no. DJ- 01, Premises no. 02-0321, Action area 1D, New Town, Kolkata- 700160
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
9477019266 |
| Fax |
|
| Email |
bdebartha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEBARTHA BANDYOPADHYAY |
| Designation |
SPECIALIST GRADE2 |
| Affiliation |
Chittaranjan National Cancer Institute |
| Address |
Chittaranjan National Cancer Institute, 2nd campus- Street no. 299, Plot no. DJ- 01, Premises no. 02-0321, Action area 1D, New Town, Kolkata- 700160
WEST BENGAL
700160
India |
| Phone |
9477019266 |
| Fax |
|
| Email |
bdebartha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DEBARTHA BANDYOPADHYAY |
| Designation |
SPECIALIST GRADE2 |
| Affiliation |
Chittaranjan National Cancer Institute |
| Address |
Chittaranjan National Cancer Institute, 2nd campus- Street no. 299, Plot no. DJ- 01, Premises no. 02-0321, Action area 1D, New Town, Kolkata- 700160
WEST BENGAL
700160
India |
| Phone |
9477019266 |
| Fax |
|
| Email |
bdebartha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Monetory support is not required exclusively for the study as it is observational, material support is from the institute |
|
|
Primary Sponsor
|
| Name |
CHITTARANJAN NATIONAL CANCER INSTITUTE |
| Address |
NEW TOWN , ACTION AREA 1, RAJARHAT, KOKKATA-700160 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Debartha Bandyopadhyay |
Chittaranjan National Cancer institute |
2nd campus, Street No.-299, Plot No. DJ-01, Premises no.02-0321, Action Area 1D, New Town, Kolkata- 700160
Kolkata
WEST BENGAL |
9477019266
bdebartha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Chittanranjan National Cancer Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (2) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (3) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
70.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(i)age 70 years or older
(ii)referred for medical preoperative assessment for pre anaesthesia clearance
(iii)undergoing a single elective major abdominal oncosurgery. |
|
| ExclusionCriteria |
| Details |
(i) Patients with metastatic disease,
(ii) emergency operations,
(iii) an expected life expectancy of less than 6 months,
(iv) initially planned for surgery but treated non-operatively. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the correlations of G8 scoring with post-operative complications. (according to Clavien-Dindo classification) |
Time point will be till discharge from the hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the association of G8 test with postoperative length of hospital stay, 30 day readmission and occurrence of post-operative delirium. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
20/09/2025 |
| 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="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
|
The study analyses the association between G8 geriatric scoring with post operative complications. Study participants will be recruited at pre-anesthesia check up clinic being aged 70 years and above, scheduled to undergo major abdominal cancer surgeries. Patients will be classified according to G8 scoring into low, intermediate and high score group. Patients’ ASA grading, functional status of the patient, tumor type and staging will be assessed. Baseline characteristics of three groups will be compared according to age, gender, type of intervention and cancer grading. Post operative outcomes as occurrence of major and minor complications, length of hospital stay, 30 day readmission and occurrence of post operative delirium will be compared among the groups. As primary outcome, post operative complications are defined and determined using Clavien- Dindo classification. The aim of this study will be to clarify whether G8 scoring, a geriatric screening tool, has independent prognostic value for elderly cancer patients undergoing major abdominal onco surgeries and what is the optimum cut-off value for predicting complications. |