Preoperative Nutritional Status and the Postoperative Outcome Clinical Trial
Official title:
Preoperative Nutritional Assessment of The Patients Undergoing Major Gastrointestinal Surgery and Their Immediate Postoperative Outcome
| NCT number | NCT04039035 |
| Other study ID # | 788/2072/73 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | May 2017 |
| Verified date | August 2019 |
| Source | National Academy of Medical Sciences, Nepal |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 134 |
| Est. completion date | May 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Nepal | Department of Surgical Gastroenterology | Kathmandu |
| Lead Sponsor | Collaborator |
|---|---|
| National Academy of Medical Sciences, Nepal |
Nepal,
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Infectious and noninfectious complication | 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. | 3 years | |
| Secondary | Length of hospital stay and cost | NRI and BMI may predict the length of hospital stay and cost | 3 years |