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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  
Name  Address 
NA  NA 
 
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  
Status 
Not Applicable 
 
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. Peri‐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.

  
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