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

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ClinicalTrials.gov Identifier: NCT04039035
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nabin Pokharel, 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.

Condition or disease
Preoperative Nutritional Status and the Postoperative Outcome

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.

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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Preoperative Nutritional Assessment of The Patients Undergoing Major Gastrointestinal Surgery and Their Immediate Postoperative Outcome
Actual Study Start Date : July 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Length of hospital stay and cost [ Time Frame: 3 years ]
    NRI and BMI may predict the length of hospital stay and cost



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039035


Locations
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Nepal
Department of Surgical Gastroenterology
Kathmandu, Nepal, 44600
Sponsors and Collaborators
National Academy of Medical Sciences, Nepal
Investigators
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Principal Investigator: Nabin Pokharel, MCh NAMS, Bir Hospital
Additional Information:
Publications of Results:

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Responsible Party: Nabin Pokharel, Assistant Professor/ Senior Medical Officer, National Academy of Medical Sciences, Nepal
ClinicalTrials.gov Identifier: NCT04039035    
Other Study ID Numbers: 788/2072/73
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We may share the datas if there is an interest from other researcher group. At present it is undecided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nabin Pokharel, National Academy of Medical Sciences, Nepal:
Nutritional Risk Index
Body mass Index
Postoperative Complications
Length of Hospital Stay and Cost.