- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03719508
Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal Surgery
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 Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kolonaki
-
Athens, Kolonaki, Greece, 10676
- Department of Nutrition and Dietetics, Evaggelismos Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative clinical complications.
Time Frame: 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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay in hospital
Time Frame: 3 months
|
Length of stay
|
3 months
|
All-cause mortality
Time Frame: 3 months
|
All-cause mortality is assessed during in-hospital stay and 90 days after the date of surgery
|
3 months
|
Readmission
Time Frame: 6 months
|
Readmission to the center within 180 days of the original procedure.
|
6 months
|
Accuracy of the POSSUM Scoring Systems to predict clinical complications and mortality.
Time Frame: 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.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: George Stylianides, MD, PhD, 2nd Department of Surgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 23/27-01-2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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