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Clinical Trials/NCT04039035
NCT04039035
Completed
Not Applicable

Preoperative Nutritional Assessment of The Patients Undergoing Major Gastrointestinal Surgery and Their Immediate Postoperative Outcome

National Academy of Medical Sciences, Nepal1 site in 1 country134 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preoperative Nutritional Status and the Postoperative Outcome
Sponsor
National Academy of Medical Sciences, Nepal
Enrollment
134
Locations
1
Primary Endpoint
Infectious and noninfectious complication
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

It was a prospective observational study, where preoperative nutritional status and early postoperative complications <30 days (infectious or noninfectious) were studied. The patients admitted between July 2015 to May 2017, who underwent major GI surgeries were included in the study. The study was designed to check if BMI and NRI can predict the postoperative outcomes in these patients.

Detailed Description

It was a prospective observational study. This study was done at NAMS, Bir Hospital, Kathmandu, Nepal between July 2015 to May 2017. All the patients who underwent major GI surgery, under general anesthesia, were included in the study. Major was defined as surgery involving \>2hrs and excluded were an emergency major operation, gallstone disease operations, patients with cough, fever, and chest infections respectively. The sample size was calculated using the formula z2pq/d2. Twice the number of sample calculated was taken into consideration and the maximum tolerable error was taken as 5%. BMI and NRI were two independent categorical variables. The dependent variables were the postoperative outcome in terms of infectious and noninfectious complications. All the preoperative parameters were of the patients were recorded. The immediate postoperative complications were documented and categorized as infectious and noninfectious complications.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
May 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Academy of Medical Sciences, Nepal
Responsible Party
Principal Investigator
Principal Investigator

Nabin Pokharel

Assistant Professor/ Senior Medical Officer

National Academy of Medical Sciences, Nepal

Eligibility Criteria

Inclusion Criteria

  • All the patients who underwent major GI surgery, under general anesthesia, were included in the study. Major was defined as surgery involving \>2hrs and

Exclusion Criteria

  • Excluded were an emergency major operation, gallstone disease operations, patients with cough, fever, and chest infections respectively

Outcomes

Primary Outcomes

Infectious and noninfectious complication

Time Frame: 3 years

Correlation between NRI/BMI and postoperative complications (infectious and noninfectious). The NRI is calculated using the formula: NRI = (15.9 × serum albumin g/L) + (41.7 × current weight/usual weight). The usual weight was defined as the stable weight 6 months before the illness in Kilograms. NRI \> 100 indicated that the patient is not malnourished, while 97.5-100 indicated mild malnourishment, 83.5-97.5 indicated moderate malnourishment and \<83.5 indicated severe malnourishment respectively. And BMI is defined as the weight in Kilograms divided by the square of height in Meters.

Secondary Outcomes

  • Length of hospital stay and cost(3 years)

Study Sites (1)

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