Impact of Nutritional Deficit in Emergency Surgery (INDIcatES)

October 7, 2021 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Impact of Nutritional Deficit in Emergency Surgery: A Pilot 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary
      • Sheffield, South Yorkshire, United Kingdom, S5 7AU
        • Sheffield Teaching Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients attending two UK hospitals which provide emergency surgery services who require an emergency laparotomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute intra-abdominal pathology
Patients admitted to hospital with acute intra-abdominal pathology
Procedure: Emergency laparotomy
Midline laparotomy for acute intra-abdominal pathology
Other Names:
  • Celiotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 90 days of admission to hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In hospital complications
Time Frame: within 90 days of admission to hospital
Complications related to surgery measured using the comprehensive complication index
within 90 days of admission to hospital
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
within 90 days of admission to hospital
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)
Measurements take at baseline, 5 days post-operatively and 90 days post-operatively
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
90 days post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Timothy O'Connor, MBChB, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH20936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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