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

NCT ID: NCT04039035

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Preoperative Nutritional Status and the Postoperative Outcome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Academy of Medical Sciences, Nepal

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nabin Pokharel

Assistant Professor/ Senior Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nabin Pokharel, MCh

Role: PRINCIPAL_INVESTIGATOR

NAMS, Bir Hospital

Locations

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Department of Surgical Gastroenterology

Kathmandu, , Nepal

Site Status

Countries

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Nepal

References

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Pichard C, Kyle UG, Morabia A, Perrier A, Vermeulen B, Unger P. Nutritional assessment: lean body mass depletion at hospital admission is associated with an increased length of stay. Am J Clin Nutr. 2004 Apr;79(4):613-8. doi: 10.1093/ajcn/79.4.613.

Reference Type RESULT
PMID: 15051605 (View on PubMed)

Yasunaga H, Horiguchi H, Matsuda S, Fushimi K, Hashimoto H, Ayanian JZ. Body mass index and outcomes following gastrointestinal cancer surgery in Japan. Br J Surg. 2013 Sep;100(10):1335-43. doi: 10.1002/bjs.9221.

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Reference Type RESULT
PMID: 19375611 (View on PubMed)

Pablo AM, Izaga MA, Alday LA. Assessment of nutritional status on hospital admission: nutritional scores. Eur J Clin Nutr. 2003 Jul;57(7):824-31. doi: 10.1038/sj.ejcn.1601616.

Reference Type RESULT
PMID: 12821882 (View on PubMed)

Buzby GP, Knox LS, Crosby LO, Eisenberg JM, Haakenson CM, McNeal GE, Page CP, Peterson OL, Reinhardt GF, Williford WO. Study protocol: a randomized clinical trial of total parenteral nutrition in malnourished surgical patients. Am J Clin Nutr. 1988 Feb;47(2 Suppl):366-81. doi: 10.1093/ajcn/47.2.366.

Reference Type RESULT
PMID: 3124598 (View on PubMed)

Veterans Affairs Total Parenteral Nutrition Cooperative Study Group. Perioperative total parenteral nutrition in surgical patients. N Engl J Med. 1991 Aug 22;325(8):525-32. doi: 10.1056/NEJM199108223250801.

Reference Type RESULT
PMID: 1906987 (View on PubMed)

Sungurtekin H, Sungurtekin U, Hanci V, Erdem E. Comparison of two nutrition assessment techniques in hospitalized patients. Nutrition. 2004 May;20(5):428-32. doi: 10.1016/j.nut.2004.01.006.

Reference Type RESULT
PMID: 15105029 (View on PubMed)

Oh CA, Kim DH, Oh SJ, Choi MG, Noh JH, Sohn TS, Bae JM, Kim S. Nutritional risk index as a predictor of postoperative wound complications after gastrectomy. World J Gastroenterol. 2012 Feb 21;18(7):673-8. doi: 10.3748/wjg.v18.i7.673.

Reference Type RESULT
PMID: 22363139 (View on PubMed)

Keys A, Fidanza F, Karvonen MJ, Kimura N, Taylor HL. Indices of relative weight and obesity. Int J Epidemiol. 2014 Jun;43(3):655-65. doi: 10.1093/ije/dyu058. Epub 2014 Apr 1.

Reference Type RESULT
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WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. doi: 10.1016/S0140-6736(03)15268-3.

Reference Type RESULT
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Kulig J, Sierzega M, Kolodziejczyk P, Dadan J, Drews M, Fraczek M, Jeziorski A, Krawczyk M, Starzynska T, Wallner G; Polish Gastric Cancer Study Group. Implications of overweight in gastric cancer: A multicenter study in a Western patient population. Eur J Surg Oncol. 2010 Oct;36(10):969-76. doi: 10.1016/j.ejso.2010.07.007. Epub 2010 Aug 21.

Reference Type RESULT
PMID: 20727706 (View on PubMed)

Related Links

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Other Identifiers

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788/2072/73

Identifier Type: -

Identifier Source: org_study_id

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