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Completed

NCT Number: NCT04696367

Impact of Nutritional Deficit in Emergency Surgery

Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

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Key information

Conditions

Emergencies Disease Attributes Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Doncaster Royal Infirmary, Doncaster, South Yorkshire, United Kingdom

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About this study

Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing to consent,

-≥ 18 years old

  • eligible for inclusion in National Emergency Laparotomy Audit
  • first procedure during admission (<7 days from admission).

Exclusion criteria

  • Recent discharge from hospital (within 60 days),
  • unable to provide informed consent
  • life expectancy <12 months
  • prisoners
  • lack mental capacity
  • language barrier affecting ability to provide consent

Treatment and study plan

Emergency laparotomy

Procedure

Midline laparotomy for acute intra-abdominal pathology

Other names: Celiotomy

Primary outcomes

  1. Time without nutrition (measured in days)

    Time frame: within 90 days of admission to hospital

    This is defined as the time elapsed between last normal enteral intake, and resumption of enteral intake, or naso-enteric feeding, or parenteral nutrition.

Secondary outcomes

  1. In hospital complications

    Time frame: within 90 days of admission to hospital

    Complications related to surgery measured using the comprehensive complication index

  2. Feasibility of completion of complications at day of discharge

    Time frame: within 90 days of admission to hospital

    Proportion of patients with a completed comprehensive complication index

  3. Change in health utility

    Time frame: Measurements take at baseline, 5 days post-operatively and 90 days post-operatively

    Measured using EQ-5D-5L (EuroQol- five dimension - five level)

  4. Feasibility of completion of EQ-5D-5L (EuroQol- five dimension - five level) at 90 days

    Time frame: 90 days post operatively

    Reported as proportion of respondents replying

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Impact of Nutritional Deficit in Emergency Surgery: A Pilot Study

Acronym: INDIcatES

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Oct 8, 2021

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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