CTRI Number |
CTRI/2021/01/030494 [Registered on: 15/01/2021] Trial Registered Prospectively |
Last Modified On: |
05/10/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Prospective observational study |
Study Design |
Other |
Public Title of Study
|
Preoperative assessment and postoperative outcomes after high risk cases of abdominal cancers |
Scientific Title of Study
|
A prospective observational study of preoperative assessment and optimization of high risk surgical patients posted for gastrointestinal cancer surgeries and their perioperative outcomes |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Protocol No 900756 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sohan Lal Solanki |
Designation |
Professor |
Affiliation |
Tata Memorial Hospital, Mumbai |
Address |
Room No 210, Department of Anaesthesiology, Critical Care andPain, 2nd Floor Main Building Tata Memorial Hospital, Mumbai
Mumbai MAHARASHTRA 400012 India |
Phone |
9869253201 |
Fax |
|
Email |
sohan.solanki@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sohan Lal Solanki |
Designation |
Professor |
Affiliation |
Tata Memorial Hospital, Mumbai |
Address |
Room No 210, Department of Anaesthesiology, Critical Care andPain, 2nd Floor Main Building Tata Memorial Hospital, Mumbai
Mumbai MAHARASHTRA 400012 India |
Phone |
9869253201 |
Fax |
|
Email |
sohan.solanki@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sohan Lal Solanki |
Designation |
Professor |
Affiliation |
Tata Memorial Hospital, Mumbai |
Address |
Room No 210, Department of Anaesthesiology, Critical Care andPain, 2nd Floor Main Building Tata Memorial Hospital, Mumbai
Mumbai MAHARASHTRA 400012 India |
Phone |
9869253201 |
Fax |
|
Email |
sohan.solanki@gmail.com |
|
Source of Monetary or Material Support
|
Tata Memorial Hospital, Mumbai |
|
Primary Sponsor
|
Name |
Tata Memorial Hospital |
Address |
Dr E Borges Marg, Parel, Mumbai-400012, India |
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 |
DrSohan Lal Solanki |
Tata Memorial Hospital |
Room No 210, 2ndFloor Main Building,Tata Memorial Hospital,Dr E Borges Marg,Parel, Mumbai Mumbai MAHARASHTRA |
9869253201
sohan.solanki@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Tata Memorial Centre IEC III |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (2) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (3) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (4) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (5) ICD-10 Condition: C20||Malignant neoplasm of rectum, (6) ICD-10 Condition: C229||Malignant neoplasm of liver, not specified as primary or secondary, (7) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (8) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NA |
NA |
Intervention |
NA |
NA |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
Gastro-intestinal cancers with American society of anesthesiologist class 1-4, having high risk (surgical or anaesthesia risk) and who are planned to be assessed in preoperative high risk joint clinic |
|
ExclusionCriteria |
Details |
Emergency Surgery |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Postoperative complications as per Clavien Dindo class of complications |
From day of surgery to 30 days postoperatively |
|
Secondary Outcome
|
Outcome |
TimePoints |
Need for postoperative ventilation, number of days of ventilation, number of days in ICU,number of stay in hospital, Re-admission in ICU and readmission in hospital and 30 days’all-cause mortality. |
From day of surgery to 30 days postoperatively |
|
Target Sample Size
|
Total Sample Size="1250" Sample Size from India="1250"
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)
|
01/02/2021 |
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="5" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The number of patients undergoing surgery and other related invasive interventions has been growing over the years; along with a large population moving into the elderly population. Abdominal surgeries carry high perioperative risks with high risk populations carrying multiple and uncontrolled comorbidities. Periâ€operative medicine is based on improving the care of patients to maximize the quality of life. High-risk surgeries have been defined as those with a mortality of >5%. A number of scoring systems and diagnostic tests have been used to help identify patients and operations with high risk and allow appropriate management to be started early in the perioperative period. The most commonly used systems are the POSSUM score and ASA grading. Perioperative medicine aims include preoperative risk stratification using cardiopulmonary exercise testing for patients undergoing major abdominal surgery, preoperative management of iron deficiency and anemia, and preoperative exercise intervention. Proof of the utilization and validity for improving surgical outcomes with such tools in preoperative care is still not well established and evidence-based developments in this field will likely be beneficial to patients undergoing major abdominal surgery, but further research into such fields is required. |