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NCT Number: NCT05608538

Evaluation of Nutritional Scores as Predictive Factors of Postoperative Outcome After Pancreatic Surgery

Patients scheduled for major pancreatic surgery will be screened for malnutrition by five screening scores chosen depending on their clinical applicability. After surgery, it will be evaluated which score predicts the best complications.

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Key information

Conditions

Pancreatic and Peripancreatic Tumors Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital

Verona, 37134, Italy

About this study

Patients scheduled for major pancreatic surgery (pancreaticoduodenectomy, distal resection, total resection) will be screened for malnutrition by the following screening scores: Nutritional Risk Screening Score 2002; Subjective Global Assessment; Malnutrition Universal Screening Tool; Mini Nutritional Assessment and Short Nutritional Assessment Questionnaire.

The postoperative outcome will be recorded, and the predictive value of each score will be calculated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 18 and 90 years undergoing major pancreatic resections (pancreaticoduodenectomy, distal pancreatic resection, total pancreatic resection) are eligible for inclusion. All patients are informed orally about all aspects of the trial. All conditions leading to primary pancreatic resection are eligible.

Exclusion criteria

  • patients undergoing minor pancreatic resections.

Treatment and study plan

Primary outcomes

  1. Evaluation of nutritional assessment score as predictive of pancreatic surgery outcomes

    Time frame: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.

    Five nutritional questionnaires are administered to each patient to assess their nutritional status and then evaluate if there is a correlation between them and the postoperative outcomes.

Secondary outcomes

  1. The correlation between nutritional scores and postoperative outcomes is based on age, type of disease, possible preoperative oncological treatments, and operation technique.

    Time frame: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.

    Association of each score with postoperative outcomes depending on certain patient's characteristics:age,type of disease,operation technique (open surgery versus laparoscopy)

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2022
Registry last updated
May 7, 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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