| CTRI Number |
CTRI/2024/07/071252 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Outcomes of cancer patients admitted to ICU after Onco-surgery |
|
Scientific Title of Study
|
Outcomes of cancer patients requiring Intensive Care Unit admission postoperatively after onco-surgery at a tertiary care centre in India: a retrospective 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 |
Dr Mehak Sharma |
| Designation |
Senior Resident(Academic) |
| Affiliation |
Dr. BRAIRCH, AIIMS New Delhi |
| Address |
Department of Onco-Anaesthesia and Palliative Medicine, Dr. BRAIRCH, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
8054212587 |
| Fax |
|
| Email |
drmehaksharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Mishra |
| Designation |
Professor |
| Affiliation |
Dr. BRAIRCH, AIIMS New Delhi |
| Address |
Room No. 249(Second Floor),Department of Onco-Anaesthesia and Palliative Medicine, Dr. BRAIRCH, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
9899061105 |
| Fax |
|
| Email |
seemamishra2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Mishra |
| Designation |
Professor |
| Affiliation |
Dr. BRAIRCH, AIIMS New Delhi |
| Address |
Room No. 249(Second Floor),Department of Onco-Anaesthesia and Palliative Medicine, Dr. BRAIRCH, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
DELHI
110029
India |
| Phone |
9899061105 |
| Fax |
|
| Email |
seemamishra2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco-anaesthesia and Palliative Medicine, Dr. BRAIRCH, AIIMS New Delhi. 110029 |
|
|
Primary Sponsor
|
| Name |
DR. BRAIRCH, AIIMS New Delhi |
| Address |
DR. BRAIRCH, All Inida Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 |
| 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 |
| Dr Mehak Sharma |
Dr. BRAIRCH, AIIMS Delhi |
Department of Onco-Anaesthesia and Palliative Medicine, Dr. BRAIRCH, AIIMS New Delhi-110029
South
DELHI |
8054212587
drmehaksharma@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Delhi Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D098||Carcinoma in situ of other specified sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of ages 18 years or above of either gender
2. Patients diagnosed with solid organ cancer undergoing onco-surgery for the same |
|
| ExclusionCriteria |
| Details |
1. Non-surgical patients with solid organ malignancy admitted to ICU.
2. Patients with haematological malignancies admitted to ICU |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the mortality rates and identify the factors associated with mortality in cancer patients admitted in intensive care units after onco-surgery |
Day 0 of admission to ICU
Day 3-5 of admission TO icu
Day of death/discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To describe the characteristics & postoperative complications in cancer patients admitted to the ICU after onco-surgery & to identify clinical features associated with outcomes |
Day 0 of admission
Day 3-5 of admission
Day of death/discharge |
|
Target Sample Size
Modification(s)
|
Total Sample Size="2500"
Sample Size from India="2500"
Final Enrollment numbers achieved (Total)= "2684"
Final Enrollment numbers achieved (India)="2684" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
01/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/02/2026 |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Cancer prevalence and its associated mortality is increasing in low-income and middle-income countries. Nearly 80% of the patients diagnosed with cancer require surgery. Despite this, fewer than 25% of the people worldwide have robust access to effective surgical care. Patients in low middle income countries are two to three times more likely to sustain a major complication or to die after cancer surgery. Rescuing patients who sustain a major complication from dying has become an important focus in quality improvement post onco-surgery. There is need to assess factors and variables linked with morbidity and mortality in patients admitted to a critical care facility after onco-surgery in Indian scenario so that measures to curb and minimize them can be undertaken. Therefore, we aim to collect data of six years retrospectively(January 2018-December 2023) of patients admitted to ICU postoperatively after onco-surgery at our centre and to identify factors associated with morbidity and mortality. |