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Clinical Trials/CTRI/2021/01/030494
CTRI/2021/01/030494RecruitingNot Applicable

A prospective observational study of preoperative assessment and optimization of high risk surgical patients posted for gastrointestinal cancer surgeries and their perioperative outcomes

Tata Memorial Hospital1 site in 1 country1,250 target enrollmentStarted: January 2, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,250
Locations
1
Primary Endpoint
Postoperative complications as per Clavien Dindo class of complications

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Emergency Surgery.

Outcomes

Primary Outcomes

Postoperative complications as per Clavien Dindo class of complications

Time Frame: From day of surgery to 30 days postoperatively

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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