Does Perioperative Parenteral Nutrition Affect Outcome in Patients Undergoing Major Abdominal Surgeries
Conditions: Parenteral Nutrition, Major Surgery, Malnutrition
Sponsor: Nepal Medical College and Teaching Hospital

 
Approval Date: 21st November,  2022 
 
DOES PERI-OPERATIVE PARENTERAL NUTRITION 
AFFECT OUTCOME IN PATIENTS UNDERGOING MAJOR 
ABDOMINAL SURGERIES 
   
                                   
 
                                   NEPAL MEDICAL COLLEGE 
SUBMITTED BY 
Prof. Dr. Nabin Pokharel 
Head of Department 
               
   
Department of Surgical Gastroenterology 
         Nepal Medical College, Attarkhel, Gokarneswor Municipality-15, Kathmandu, Nepal 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RESEARCH DESIGN: 
 
Type of study:        
Retrospective observational study 
Place of study:        
Department of Surgical Gastroenterology, Nepal 
Medical College and Teaching Hospital, Attarkhel, 
Gokarneshwor-08, Kathmandu. 

Duration of study:  2017, January 1st to 2022, August 31st (5 years 7 
months) 
Sampling technique: Consecutive sampling technique 
Sample Size:            
To select the appropriate sample size, we considered the prevalence of 
malnutrition in surgical patients to be 24% (3) at a confidence interval of 95% (Z 
= 1.96), and a precision (d) of 7%. Based on these calculations, the sample size 
obtained was 143. 
We obtained the sample size using the following formula: 
For large population (infinite population) 
          = 3.84*0.24*0.76/(0.07*0.07) = 142.9 = 143 
n = Sample size 
Z2= 1.96*1.96=3.84 
p = Prevalence value = 24%= 0.24 
q = 1-p = 1-0.24 = 0.76 
d = desirable error or precision level (5% to 10%) = 7% = 0.07 (pre-set 
value) 
  
Inclusion criteria: 
1. All patients who underwent major gastrointestinal surgery after receiving 
perioperative TPN. 

   Exclusion criteria: 
1.   
Patient refused to participate. 
2.   
Perioperative TPN was not given as per the protocol. 
Ethical consideration: 
All patients enrolled in the study were explained about the enrollment, and verbal 
and written consent were obtained from the patient. Patients were counseled about 
the strict confidentiality that would be maintained throughout their participation 
in this study, and that their name would not be disclosed in the proforma or after 
the completion of study until voluntarily disclosed by the patient. Ethical approval 
will be obtained from the Institutional Review Committee (IRC) of Nepal Medical 
College and Teaching Hospital. 
Data collection: All patients that undergo major gastroenterological surgeries 
are always entered in our data sheet maintained by the department. As all the data 
regarding the hospital stay, course of illness, management and operation 
procedures are clearly maintained in these data sheets, we will only select those 
cases who received perioperative TPN. A sample of this data sheet which is also 
our proforma is shown in Annex I. 
Study Procedure:  
1. Consent: After obtaining ethical clearance from the IRC, those patients that 
fulfill the inclusion criteria will be offered detailed printed information 
about the proposed study. Since this is a retrospective study, phone calls 
will be done to the patients and their relatives for consent. Patients agreeing 
to take part in the study will be requested to sign the consent form. After 
signing the consent, the patient’s data will be recruited in this study. There 
will be no discrimination of sex, race, religion and geography.  

2. Nutritional status assessment: All the patients were evaluated for nutritional 
status by following the ESPEN guidelines10 at the time of admission. 
According to the guidelines, the diagnosis of malnutrition is based on two 
options:  
(1) BMI < 18.5 kg/m2,  
(2) Combined:  
 Weight loss >10% indefinite of time or >5% over 3 months 
and  
 Either reduced BMI (<20 kg/m2 in younger than 70 or <22 
kg/m2 in patients older than 70 years) or fat free mass index 
(FFMI) < 15 in women and 17 in men.  
Similarly patients at severe nutritional deficiency risk are defined by 
presence of one of the following:  
(1) Weight loss >10–15% within 6 months,  
(2) BMI < 18.5 kg/m2, and  
(3) Preoperative serum albumin < 30 g/L (without evidence of liver or 
kidney dysfunction).  
3. Routes and selection of PN: All the patients who were found to have 
malnutrition or were at severe risk of nutrition deficiency were given 
preoperative PN. PN was given as infusion via central venous catheter from 
the day of admission via central venous catheter.11 The CVC was kept by 
the anesthesiology team on the day of admission. The PN was available in 
a standard 3-compartment package developed by BAXTER and comprising 
lipid, carbohydrate and amino acids with minerals.  

4. Duration and dosing of PN: In those patients who required emergency 
surgery, PN was given in postoperative period until resumption of oral 
feeding. In non-emergent cases where surgery could be delayed for 5 days, 
PN was given for 5 days preoperatively based on the fact that our body 
needs at least 5-7 days to recover its full physiological activity and body 
protein framework and was continued in the post-operative period until the 
resumption of enteral feeding. The dosing of PN was based on ESPEN 
guidelines with total energy of 25-30Kcal/kg/day and 1.2g/kg/day of 
proteins.  
5. Intraoperative and postoperative status: All patients underwent surgery 
after preoperative assessment on 5th day onwards of admission. All the 
surgeries were done by the same team of surgeons. The intraoperative 
events were recorded by taking in consideration the anesthesiology chart. 
Postoperatively their progress as well as outcome were filled in the 
datasheet everyday till discharge.  
6. Complications: The complications faced by the patient were graded 
according to the Clavien-Dindo Classification system12 by keeping records 
till 30 days of the surgical procedure date.  
 
 
Data Analysis Technique: Data collected on a hard copy proforma will be 
entered and analyzed in Microsoft excel and into IBM- Statistical Package for the 
Social Sciences (SPSS) version 16.0 respectively. Continuous variables will be 
expressed as the mean value + or - standard deviation (SD) and range, while 
categorical variables will be expressed as proportions. We will use the chi-square 
test and the exact test of Fischer for analysis of categorical data and univariate 

linear regression analysis to show association. The data, after analysis, will be 
reported with descriptive statistics, with all data reported as mean + SD, and the 
final result will be compared with various studies listed in the Literature Review 
section. Various frequency tables, charts, graphs, trends, plots and bar diagrams 
will be used to present the data.