A study to evaluate an exercise tolerance test to predict post operative outcome in major abdominal surgeries
Not Applicable
- Conditions
- Health Condition 1: C15-C26- Malignant neoplasms of digestive organsHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2023/08/056842
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients aged = 18 years and = 80 years.
2.Planned for major upper GI and HPB surgery.
3.Completed pre-anaesthesia assessment (PAC) and deemed fit to undergo surgery.
4.ECOG 0-2
Exclusion Criteria
1.Patients undergoing emergency surgery.
2.Acute MI
3.Unstable angina
4.Uncontrolled arrhythmias
5.Hemodynamic compromise
6.Endocarditis
7.Myocarditis
8.Pericarditis
9.Symptomatic aortic stenosis.
10.Uncontrolled heart failure.
11.Uncontrolled asthma
12.Acute pulmonary embolism.
13.Suspected dissecting aneurysm
14.DVT
15.Pulmonary oedema
16.Acute respiratory failure
17.Room air SpO2 <85%
18.Mental impairments and inability to co-operate.
19.Orthopaedic or neurologic impairments that prevent or impair walking.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.30-day major morbidity defined as any complication graded Clavien- Dindo IIIa & aboveTimepoint: 30 days from the date of surgery
- Secondary Outcome Measures
Name Time Method 2.30-day mortality defined as death from any cause within 30 days from the date of surgery. <br/ ><br>3.Hospital stay defined as the duration in days from the date of surgery till discharge. <br/ ><br>4.Re-admission rate defined as admission for any cause, within 30 days after discharge. <br/ ><br>5.ICU stay defined as the duration from the date of surgery till transfer out of the ICU. <br/ ><br>6.ICU re admission rate defined as admission back to ICU after being sent to ward from ICU post-surgery. <br/ ><br>7.Time to adjuvant therapy defined as the duration in days from the date of discharge till the date of starting adjuvant therapy, if indicated. <br/ ><br>8.Incidence of PPC is defined as any post-operative pulmonary complicationsTimepoint: 30 days from the date of surgery