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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
All patients aged 18years or more undergoing elective hepatic ,pancreatic and HIPEC surgery, |
|
Intervention / Comparator Agent
|
|
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. |