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INDIcatES: Impact of Nutritional Deficit in Emergency Surgery

Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04696367
Collaborator
(none)
59
Enrollment
2
Locations
16.9
Actual Duration (Months)
29.5
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Emergency laparotomy

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 Design

Study Type:
Observational
Actual Enrollment :
59 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Nutritional Deficit in Emergency Surgery: A Pilot Study
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time without nutrition (measured in days) [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 Outcome Measures

    1. In hospital complications [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 [within 90 days of admission to hospital]

      Proportion of patients with a completed comprehensive complication index

    3. Change in health utility [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 [90 days post operatively]

      Reported as proportion of respondents replying

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Doncaster Royal Infirmary Doncaster South Yorkshire United Kingdom DN2 5LT
    2 Sheffield Teaching Hospitals Sheffield South Yorkshire United Kingdom S5 7AU

    Sponsors and Collaborators

    • Sheffield Teaching Hospitals NHS Foundation Trust

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheffield Teaching Hospitals NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT04696367
    Other Study ID Numbers:
    • STH20936
    First Posted:
    Jan 6, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust
    emergency surgery
    malnutrition
    pilot study
    Additional relevant MeSH terms:
    Malnutrition
    Emergencies

    Study Results

    No Results Posted as of Oct 8, 2021