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Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective Study

2014-08-27 03:17:32 | BioPortfolio

Summary

The primary objective of this study is to evaluate the effectives of enteral nutrition in the treatment of pancreatic fistulas. The ratio of pancreatic fistula closure after 30 days is selected as the primary outcome measure with the null hypothesis assuming that enteral nutrition provides better results than parenteral nutrition as far as the closure ratio, time to closure and treatment-related complications are concerned.

Description

The research into field of the role of enteral nutrition in the treatment of pancreatic fistulas is fully justified by the lower cost and complications' rate of EN compared to PN observed in clinical trials comparing enteral and parnetral route of feeding in pre- and postoperative period. Such authors as Braga, Torosian, Lewis or Sand et al. proved that use of enteral nutrition led to smaller amount of complication (especially infectious) and improved the outcome of surgery. The only method to verify the role of enteral nutrition is the prospective, randomized clinical trial.

STUDY OBJECTIVES 2.1 Primary Objective The primary objective of this study is to evaluate the effectives of enteral nutrition in the treatment of pancreatic fistulas. The ratio of pancreatic fistula closure after 30 days is selected as the primary outcome measure with the null hypothesis assuming that enteral nutrition provides better results than parenteral nutrition as far as the closure ratio, time to closure and treatment-related complications are concerned.

2.2 Secondary Objectives

The secondary objectives are to:

- determine time to fistula closure (defined as time between initiation of treatment and confirmed fistula closure),

- determine rates of fistula and treatment-related complications,

- assess changes in quality of life (QoL),

- determine economic costs of therapy. (for such terms as: fistula closure, time to closure see definition on page 3) For QoL assessment the EORTC QLQ - PAN26 score in Polish version (translation was approved by EORTC) will be used.

Benefits of the study:

1. the implementation of safer and less expensive conservative procedure. Basis: Costs of enteral nutrition are significantly lower than PN and EN is significantly safer than PN especially as far as infectious complications are concerned.

2. the enhancement of indications for enteral nutrition.

The confirmation of the null hypothesis allows recommending enteral nutrition as a method of choice for pancreatic fistula treatment.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pancreatic Fistula

Intervention

enteral nutrition, Parenteral nutrition

Location

Nutrimed Medical Corporation
Krakow
Malopolska
Poland
30-798

Status

Completed

Source

Jagiellonian University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:32-0400

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PubMed Articles [3825 Associated PubMed Articles listed on BioPortfolio]

Enteral versus parenteral nutrition and enteral versus a combination of enteral and parenteral nutrition for adults in the intensive care unit.

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Medical and Biotech [MESH] Definitions

The administering of nutrients for assimilation and utilization by a patient who cannot maintain adequate nutrition by enteral feeding alone. Nutrients are administered by a route other than the alimentary canal (e.g., intravenously, subcutaneously).

The at-home administering of nutrients for assimilation and utilization by a patient who cannot maintain adequate nutrition by enteral feeding alone. Nutrients are administered via a route other than the alimentary canal (e.g., intravenously, subcutaneously).

Specialized solutions for PARENTERAL NUTRITION. They may contain a variety of MICRONUTRIENTS; VITAMINS; AMINO ACIDS; CARBOHYDRATES; LIPIDS; and SALTS.

Nutritional support given via the alimentary canal or any route connected to the gastrointestinal system (i.e., the enteral route). This includes oral feeding, sip feeding, and tube feeding using nasogastric, gastrostomy, and jejunostomy tubes.

Evaluation and measurement of nutritional variables in order to assess the level of nutrition or the NUTRITIONAL STATUS of the individual. NUTRITION SURVEYS may be used in making the assessment.

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