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Clinical Trials/CTRI/2018/07/014946
CTRI/2018/07/014946Not yet recruitingNot Applicable

Post- operative pulmonary complications-Incidence and Risk factors in patients undergoing major abdominal cancer surgery

Tata Memorial Hospital1 site in 1 country350 target enrollmentStarted: July 20, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
350
Locations
1
Primary Endpoint
Incidence of post-operative pulmonary complications in patients undergoing major abdominal cancer surgery

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients aged 18 years or more Patients undergoing elective hepatic, pancreatic and HIPEC surgery.

Exclusion Criteria

  • •Pregnant and lactating women Patient refusal to participate in this study.

Outcomes

Primary Outcomes

Incidence of post-operative pulmonary complications in patients undergoing major abdominal cancer surgery

Time Frame: Before the discharge from hospital

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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