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CTRI Number  CTRI/2018/07/014946 [Registered on: 18/07/2018] Trial Registered Prospectively
Last Modified On: 18/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Postoperative Pulmonary Complications: Incidence and risk factors in patients undergoing major abdominal cancer surgery 
Scientific Title of Study   Post- operative pulmonary complications-Incidence and Risk factors in patients undergoing major abdominal cancer surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vandana Agarwal 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  TATA MEMORIAL HOSPITAL Dept. of Anaesthesia, Critical care and Pain Dr E Borges marg, Parel,Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177042   
Fax    
Email  vandanachaukar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana Agarwal 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  TATA MEMORIAL HOSPITAL Dept. of Anaesthesia, Critical care and Pain Dr E Borges marg, Parel,Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177042   
Fax    
Email  vandanachaukar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shruti S Kalli 
Designation  PG STUDENT 
Affiliation  Tata Memorial Hospital 
Address  TATA MEMORIAL HOSPITAL Dept. of Anaesthesia, Critical care and Pain Dr E Borges marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9619674359  
Fax    
Email  kallishruti@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care and Pain, Tata memorial Hospital  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges marg, Parel, Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vandana Agarwal  Tata Memorial Hospital  Dept. of Anaesthesia, Critical care and Pain Dr E Borges marg, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
02224177042

vandanachaukar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All patients aged 18years or more undergoing elective hepatic ,pancreatic and HIPEC surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged 18 years or more
Patients undergoing elective hepatic, pancreatic and HIPEC surgery

 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Patient refusal to participate in this study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of post-operative pulmonary complications in patients undergoing major abdominal cancer surgery  Before the discharge from hospital 
 
Secondary Outcome  
Outcome  TimePoints 
Risk factors associated with post-operative pulmonary complications and outcomes such as length of stay (ICU and postoperative), discharge status (alive or dead), need for readmission within 30 days of discharge. Predictive ability of ARISCAT in our patients undergoing major abdominal surgery  Within 30 days of hospital discharge 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   20/07/2018 
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   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Despite the advancement in the peri-operative care, surgical complications do occur and curtail the recovery of the patient. Amongst them pulmonary complications are the most frequent in upper abdominal surgeries in the post-operative period.

Post-operative pulmonary complications (PPC)encompass a wide range of conditions ranging from atelectasis requiring administering of oxygen to ARDS requiring invasive mechanical ventilation. These pulmonary complications increase the risk of morbidity and mortality, length of hospital stay and hence the health -related cost. There are numerous risk factors, which predispose the patient to these complications. Greater the number of risk factors higher the risk of developing complications. The risk factors are categorised as patient, surgical and anaesthesia related factors. Some of these factors are modifiable and some are not. Patient factors are age, male gender, high BMI, history of smoking and alcohol consumption, higher ASA grade, preoperative impaired mobility, respiratory infection within a month before surgery.  Surgery related factors are type of incision, its site, prolonged surgery (>210 minutes), contaminated surgical procedure. Anaesthesia related are prolonged duration, intraoperative positive fluid balance, failure to use protective lung ventilation strategy, presence of nasogastric tube at the end of the surgery, elective mechanical ventilation post-operatively and inadequate post-op analgesia.

Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) study addressed the problem of differences across surgical contexts by using a population based approach that was representative of a wide range of procedures and patients in a geographically defined, mixed urban-rural practice setting (in Spain). It is clinically practical seven-factor scoring system used to assess the risk of a composite PPC. We have implemented Enhanced recovery program a few years back which takes into consideration some of the above mentioned factors and optimises patient before surgery.  Therefore, we would like to study the incidence of postoperative pulmonary complications and associated risk factors in patients undergoing major abdominal cancer surgery and evaluate the accuracy of ARISCAT score in predicting postoperative pulmonary complications.

 
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