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

Completed

• Conditions: Pancreatic and Peripancreatic Tumors

• Registration Number: NCT05608538
• Lead Sponsor: Universita di Verona

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-08
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of nutritional assessment score as predictive of pancreatic surgery outcomes	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 Outcome Measures

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

Trial Locations

Locations (1)

General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital; 🇮🇹 Verona, Italy