Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal Surgery

Completed

• Conditions: Abdominal Surgery

• Registration Number: NCT03719508
• Lead Sponsor: Evangelismos Hospital

Brief Summary

Predictive Value of Various Nutritional Screening and Assesment Tools and a Surgery Scoring System (POSSUM Score) for Predicting Postoperative Complications in Patients Scheduled for Abdominal Surgery.

Detailed Description

Preoperative malnutrition in surgical patients is an established risk factor of peri-operative morbidity and mortality, post-operative complications, infections and increased length of hospital stay. The reported prevalence of malnutrition in gastrointestinal (GI) and major abdominal surgery patients ranges from 30% to 50%. For these reasons it is important to recognize malnourished patients before surgery in order to provide the most appropriate preoperative nutritional therapy which will in turn improve nutritional status and reduce postoperative complications and length of hospital stay.

The aim of the present study was to compare the prognostic power of different screening tools for post - op complications. This was a prospective observational cohort study, performed in patients scheduled for an abdominal operation in the Second Department of Surgery, Evangelismos General Hospital in Athens, Greece. All patients were screened at admission and before operation. Data were collected in a special form by the dietician and the surgeon, with the use of screening tools and the local Electronic Medical Record System called "Emrora". Patients were followed up after surgery until discharge by the surgeon who recorded any complication or case of death in a new form.

Study Timeline

• Study Start: 2013-01-05
• Primary Completion: 2017-10-10
• Study Completion: 2017-12-20
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• 18 years at least
• Diseases of the digestive tract (oesophageal, gastric or intestinal), or other abdominal diseases requiring elective surgery,

Exclusion Criteria

• Age < 18
• Pregnancy
• Major coagulopathy
• Permanent pacemaker
• Specific preoperative nutritional support before admission to hospital
• Unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative clinical complications.	3 months	Number of respiratory, cardiovascular, renal, neurological, infectious and surgical after surgery. Complication will be defined by the Clavien-Dindo classification and our primary outcome will be long-term complications higher than grade III.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	3 months	All-cause mortality is assessed during in-hospital stay and 90 days after the date of surgery
Length of stay in hospital	3 months	Length of stay
Readmission	6 months	Readmission to the center within 180 days of the original procedure.
Accuracy of the POSSUM Scoring Systems to predict clinical complications and mortality.	1 month	Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the P-POSSUM Scoring Systems to Predict clinical complications and mortality.

Trial Locations

Locations (1)

Department of Nutrition and Dietetics, Evaggelismos Hospital; 🇬🇷 Athens, Kolonaki, Greece