Abdominal SurgeryNCT03719508
Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal Surgery
An observational study of Abdominal Surgery, run by Evangelismos Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abdominal Surgery
- How many people
- 450 participants
- Where
- 1 siteGreece
- Study dates
- 5 Jan 2013to 20 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years at least
- Diseases of the digestive tract (oesophageal, gastric or intestinal), or other abdominal diseases requiring elective surgery,
Who cannot join
- Age < 18
- Pregnancy
- Major coagulopathy
- Permanent pacemaker
- Specific preoperative nutritional support before admission to hospital
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Nutrition and Dietetics, Evaggelismos Hospital
Athens, Kolonaki, 10676
About this study
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
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.
Read the 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.
- Conditions
- Abdominal Surgery
- Keywords
- Nutritional assesment, Nutritional screening tools, Abdominal Surgery, Stomach Neoplasms, Colorectal Surgery
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Length of stay in hospital
Length of stay
Measured: 3 months
All-cause mortality
All-cause mortality is assessed during in-hospital stay and 90 days after the date of surgery
Measured: 3 months
Readmission
Readmission to the center within 180 days of the original procedure.
Measured: 6 months
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start5 Jan 2013
- Primary completion10 Oct 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Karayiannis, Evangelismos Hospital
- Investigators
- George Stylianides, MD, PhD, Study director, 2nd Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719508
- Sponsor's protocol ID
- 23/27-01-2014
- Status last verified
- Jul 2020
- First submitted
- 22 Oct 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03719508
- Acronym / sponsor ID
- 23/27-01-2014
- Conditions
- Abdominal Surgery
- Keywords
- Nutritional assesment, Nutritional screening tools, Abdominal Surgery, Stomach Neoplasms, Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Study start
- 5 Jan 2013 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 years at least
- Diseases of the digestive tract (oesophageal, gastric or intestinal), or other abdominal diseases requiring elective surgery,
Key exclusion criteria (6 listed)
- Age < 18
- Pregnancy
- Major coagulopathy
- Permanent pacemaker
- Specific preoperative nutritional support before admission to hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Length of stay in hospital
Time frame: 3 months
All-cause mortality
Time frame: 3 months
Readmission
Time frame: 6 months
Accuracy of the POSSUM Scoring Systems to predict clinical complications and mortality.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Stylianides, MD, PhD study director
2nd Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Surgery, run by Evangelismos Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative clinical complications. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.