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NCT Number: 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.

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Key information

Conditions

Abdominal Surgery Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nutrition and Dietetics, Evaggelismos Hospital

Athens, Kolonaki, 10676, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Length of stay in hospital

    Time frame: 3 months

    Length of stay

  2. 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. Readmission

    Time frame: 6 months

    Readmission to the center within 180 days of the original procedure.

  4. 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.

Sponsors and collaborators

Lead sponsor

Evangelismos Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2018
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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