Perioperative TPN Improves Surgical Outcomes

Completed

• Conditions: Parenteral Nutrition; Major Surgery; Malnutrition
• Interventions: Dietary Supplement: TPN-N7 Baxter

• Registration Number: NCT06573632
• Lead Sponsor: Nepal Medical College and Teaching Hospital

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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malnutrition	TPN-N7 Baxter	All malnutrition patients to received TPN for 5 days preoperatively as applicable and continued postoperatively.

Primary Outcome Measures

Name	Time	Method
studying the effects of TPN on mortality	through study completion, an average of 5years	comparison of perioperative and postoperative TPN in terms of number of mortality cases
studying the effects of TPN on length of hospital stay	through study completion, an average of 5years	comparison of perioperative and postoperative TPN in terms of mean length of stay in days
studying the effect of albumin levels on length of hospital stay	through study completion, an average of 5years	comparison of low and normal albumin levels in terms of mean length of stay in days
studying the effect of albumin levels on mortality	through study completion, an average of 5years	comparison of low and normal albumin levels in terms of number of mortality cases
studying the effect of albumin levels on complication using grades	through study completion, an average of 5years	comparison of low and normal albumin levels in terms of Clavien-Dindo Classification grades
studying the effects of TPN on complications using grades	through study completion, an average of 5years	comparison of perioperative and postoperative TPN in terms of Clavien-Dindo classification grades

Trial Locations

Locations (1)

Nepal Medical College Teaching Hospital; 🇳🇵 Kathmandu, Bagmati, Nepal