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

Completed

• Conditions: Preoperative Nutritional Status and the Postoperative Outcome

• Registration Number: NCT04039035
• Lead Sponsor: National Academy of Medical Sciences, Nepal

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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Study First Submitted: 2019-07-27
• Study First Submitted QC: 2019-07-27
• Study First Posted: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infectious and noninfectious complication	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 Outcome Measures

Name	Time	Method
Length of hospital stay and cost	3 years	NRI and BMI may predict the length of hospital stay and cost

Trial Locations

Locations (1)

Department of Surgical Gastroenterology; 🇳🇵 Kathmandu, Nepal