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

Sponsor

Universita di Verona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05608538

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic and Peripancreatic Tumors

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

Aug 15, 2023

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.