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

September 17, 2019 updated by: Nabin Pokharel, National Academy of Medical Sciences, Nepal
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal, 44600
        • Department of Surgical Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patient who underwent major GI surgery in NAMS Bir Hospital (a tertiary level hospital of Government of Nepal) between 2015 to 2017.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay and cost
Time Frame: 3 years
NRI and BMI may predict the length of hospital stay and cost
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Academy of Medical Sciences, Nepal

Investigators

  • Principal Investigator: Nabin Pokharel, MCh, NAMS, Bir Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

July 27, 2019

First Submitted That Met QC Criteria

July 27, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 788/2072/73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We may share the datas if there is an interest from other researcher group. At present it is undecided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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