Perioperative TPN Improves Surgical Outcomes

NCT ID: NCT06573632

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Parenteral Nutrition Major Surgery Malnutrition

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Malnutrition

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

TPN-N7 Baxter

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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TPN-N7 Baxter

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nepal Medical College and Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nabin Pokharel

Prof Dr. Nabin Pokharel, Head of Department of Surgical Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nepal Medical College Teaching Hospital

Kathmandu, Bagmati, Nepal

Site Status

Countries

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Nepal

References

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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.

Reference Type BACKGROUND
PMID: 20375423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26688128 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 32384662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27112357 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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26-079/080

Identifier Type: -

Identifier Source: org_study_id

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