Perioperative TPN Improves Surgical Outcomes

August 23, 2024 updated by: Nabin Pokharel, Nepal Medical College and Teaching Hospital

Does Perioperative Parenteral Nutrition Affect Outcome in Patients Undergoing Major Abdominal Surgeries

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Kathmandu, Bagmati, Nepal
        • Nepal Medical College Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Malnutrition
All malnutrition patients to received TPN for 5 days preoperatively as applicable and continued postoperatively.
Dietary supplement: TPN-N7 Baxter
providing TPN to all malnutrition patients preoperatively as well as postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
studying the effects of TPN on length of hospital stay
Time Frame: through study completion, an average of 5years
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
Time Frame: through study completion, an average of 5years
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
Time Frame: through study completion, an average of 5years
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
Time Frame: through study completion, an average of 5years
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
Time Frame: through study completion, an average of 5years
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
Time Frame: through study completion, an average of 5years
comparison of low and normal albumin levels in terms of Clavien-Dindo Classification grades
through study completion, an average of 5years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nepal Medical College and Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-079/080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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