Clinical trial NCT03719508: Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Surgery
Keywords: Nutritional assesment
Nutritional screening tools
Abdominal Surgery
Stomach Neoplasms
Colorectal Surgery
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged at least 18 years who presented with diseases of the digestive tract (oesophageal, gastric or intestinal), or with other abdominal diseases requiring elective surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative clinical complications.
timeFrame: 3 months
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: 3 months
measure: All-cause mortality
timeFrame: 3 months
measure: Readmission
timeFrame: 6 months
measure: Accuracy of the POSSUM Scoring Systems to predict clinical complications and mortality.
timeFrame: 1 month
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Nutrition and Dietetics, Evaggelismos Hospital
state: Kolonaki
Study officials:
affiliation: 2nd Department of Surgery
name: George Stylianides, MD, PhD
role: STUDY_DIRECTOR
References: