Clinical trial NCT06573632: Perioperative TPN Improves Surgical Outcomes
Official title: Does Perioperative Parenteral Nutrition Affect Outcome in Patients Undergoing Major Abdominal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parenteral Nutrition
Major Surgery
Malnutrition
Keywords: parenteral nutrition
TPN
major surgery
malnutrition in surgery
clavien-dindo classification
Lead sponsor: Nepal Medical College and Teaching Hospital
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the Surgery department at Nepal Medical College teaching hospital and having malnutrition.

Brief summary: Preoperative optimization of patients is a well known concept. Not all patients can tolerate feeds and as such TPN is given. TPN given preoperatively and continued postoperatively in selected group of patients can significantly improve the surgical outcomes and lower the morbidity as well as mortality. So the investigators aim to find the impact of TPN in malnutritional surgical patients.

Detailed description: Any patient who is at risk of malnutrition as well as already malnutritioned were given preoperative TPN for 5 days. After 5 days, elective surgery was done and TPN was continued postoperatively until patient could consume 50% of their daily requirements orally. Patients who underwent emergency surgeries were also enrolled in this study as these patients could receive TPN only postoperatively.

Daily patient charting with Clavien Dindo Classification, length of stay and mortality were mentioned and verified by the operating surgical team.

Data was maintained electronically by the surgical team. Data was also entered in MS-EXCEL at the time of patient discharge. Since data was maintained on everyday basis till patient discharge and does not include follow-ups, there are no missing data.

Upon completion of study, all data will be exported to SPSS and analyzed accordingly using means, SDs, Chi-square and Fisher exact test.

Eligibility criteria: Inclusion Criteria:

* 1. All patients who underwent major gastrointestinal surgery and received perioperative TPN or postoperative TPN

Exclusion Criteria:

* Perioperative TPN administration that did not follow the study protocol
* TPN given for reasons other than malnutrition

Primary outcomes:
measure: studying the effects of TPN on length of hospital stay
timeFrame: through study completion, an average of 5years
measure: studying the effects of TPN on mortality
timeFrame: through study completion, an average of 5years
measure: studying the effects of TPN on complications using grades
timeFrame: through study completion, an average of 5years
measure: studying the effect of albumin levels on length of hospital stay
timeFrame: through study completion, an average of 5years
measure: studying the effect of albumin levels on mortality
timeFrame: through study completion, an average of 5years
measure: studying the effect of albumin levels on complication using grades
timeFrame: through study completion, an average of 5years
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Nepal Medical College Teaching Hospital
state: Bagmati
Study officials:
References:
citation: Jensen GL, Mirtallo J, Compher C, Dhaliwal R, Forbes A, Grijalba RF, Hardy G, Kondrup J, Labadarios D, Nyulasi I, Castillo Pineda JC, Waitzberg D; International Consensus Guideline Committee. Adult starvation and disease-related malnutrition: a proposal for etiology-based diagnosis in the clinical practice setting from the International Consensus Guideline Committee. JPEN J Parenter Enteral Nutr. 2010 Mar-Apr;34(2):156-9. doi: 10.1177/0148607110361910.
citation: Thomas MN, Kufeldt J, Kisser U, Hornung HM, Hoffmann J, Andraschko M, Werner J, Rittler P. Effects of malnutrition on complication rates, length of hospital stay, and revenue in elective surgical patients in the G-DRG-system. Nutrition. 2016 Feb;32(2):249-54. doi: 10.1016/j.nut.2015.08.021. Epub 2015 Sep 25.
citation: Lakananurak N, Gramlich L. The Role of Preoperative Parenteral Nutrition. Nutrients. 2020 May 6;12(5):1320. doi: 10.3390/nu12051320.
citation: Zhao XF, Wu N, Zhao GQ, Liu JF, Dai YF. Enteral nutrition versus parenteral nutrition after major abdominal surgery in patients with gastrointestinal cancer: a systematic review and meta-analysis. J Investig Med. 2016 Jun;64(5):1061-74. doi: 10.1136/jim-2016-000083. Epub 2016 Apr 25.