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OpenTrials
Completed

NCT Number: NCT06573632

Perioperative TPN Improves Surgical Outcomes

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.

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Key information

Conditions

Parenteral Nutrition Hyperphagia Major Surgery Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

All sexes

Study type

Observational

Primary location

Nepal Medical College Teaching Hospital

Kathmandu, Bagmati, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TPN-N7 Baxter

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Nepal Medical College and Teaching Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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