Perioperative TPN Improves Surgical Outcomes

NCT06573632 | Completed

• 1 other identifier: 26-079/080
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenteral Nutrition; Major Surgery; Malnutrition

Keywords

parenteral nutrition; TPN; major surgery; malnutrition in surgery; clavien-dindo classification

Outcome Measures

Primary Outcomes (6)

• studying the effects of TPN on length of hospital stay

  comparison of perioperative and postoperative TPN in terms of mean length of stay in days

  through study completion, an average of 5years

• studying the effects of TPN on mortality

  comparison of perioperative and postoperative TPN in terms of number of mortality cases

  through study completion, an average of 5years

• studying the effects of TPN on complications using grades

  comparison of perioperative and postoperative TPN in terms of Clavien-Dindo classification grades

  through study completion, an average of 5years

• studying the effect of albumin levels on length of hospital stay

  comparison of low and normal albumin levels in terms of mean length of stay in days

  through study completion, an average of 5years

• studying the effect of albumin levels on mortality

  comparison of low and normal albumin levels in terms of number of mortality cases

  through study completion, an average of 5years

• studying the effect of albumin levels on complication using grades

  comparison of low and normal albumin levels in terms of Clavien-Dindo Classification grades

  through study completion, an average of 5years

Study Arms (1)

Malnutrition

All malnutrition patients to received TPN for 5 days preoperatively as applicable and continued postoperatively.

Dietary Supplement: TPN-N7 Baxter

Interventions

TPN-N7 Baxter DIETARY_SUPPLEMENT

providing TPN to all malnutrition patients preoperatively as well as postoperatively.

Malnutrition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to the Surgery department at Nepal Medical College teaching hospital and having malnutrition.

You may qualify if:

• \. All patients who underwent major gastrointestinal surgery and received perioperative TPN or postoperative TPN

You may not qualify if:

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

Sponsors & Collaborators

• Nepal Medical College and Teaching Hospital: lead

Study Sites (1)

Nepal Medical College Teaching Hospital

Kathmandu, Bagmati, Nepal

Location

Related Publications (4)

• 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.

  PMID: 20375423 BACKGROUND

• 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.

  PMID: 26688128 BACKGROUND

• Lakananurak N, Gramlich L. The Role of Preoperative Parenteral Nutrition. Nutrients. 2020 May 6;12(5):1320. doi: 10.3390/nu12051320.

  PMID: 32384662 BACKGROUND

• 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.

  PMID: 27112357 BACKGROUND

MeSH Terms

Conditions

Hyperphagia; Malnutrition

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr. Nabin Pokharel, Head of Department of Surgical Gastroenterology

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 27, 2024
• Study Start: October 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)