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

Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719508
• Other study ID #: 23/27-01-2014
• Status: Completed
• Start date: January 5, 2013
• Est. completion date: December 20, 2017

Study information

• Verified date: July 2020
• Source: Evangelismos Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 20, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery

Locations

Country	Name	City	State
Greece	Department of Nutrition and Dietetics, Evaggelismos Hospital	Athens	Kolonaki

Sponsors (1)

Lead Sponsor	Collaborator
Evangelismos Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative clinical complications.	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.	3 months
Secondary	Length of stay in hospital	Length of stay	3 months
Secondary	All-cause mortality	All-cause mortality is assessed during in-hospital stay and 90 days after the date of surgery	3 months
Secondary	Readmission	Readmission to the center within 180 days of the original procedure.	6 months
Secondary	Accuracy of the POSSUM Scoring Systems to predict clinical complications and mortality.	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.	1 month

External Links

•   Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal Surgery
•   The Efficacy of Nutritional Screening and Assessment in Prediction of Post Operative Complications and Hospital Readmission in Patients Undergoing Abdominal Surgery