Impact of Nutritional Deficit in Emergency Surgery

NCT04696367 | Completed

• 1 other identifier: STH20936
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 2

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.

Conditions

Emergencies; Surgery; Malnutrition

Keywords

emergency surgery; malnutrition; pilot study

Outcome Measures

Primary Outcomes (1)

• Time without nutrition (measured in days)

  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 Outcomes (4)

• In hospital complications

  within 90 days of admission to hospital

• Feasibility of completion of complications at day of discharge

  within 90 days of admission to hospital

• Change in health utility

  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

  90 days post operatively

Study Arms (1)

Patients with acute intra-abdominal pathology

Patients admitted to hospital with acute intra-abdominal pathology

Procedure: Emergency laparotomy

Interventions

Emergency laparotomy PROCEDURE

Midline laparotomy for acute intra-abdominal pathology

Also known as: Celiotomy

Patients with acute intra-abdominal pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Willing to consent,
• ≥ 18 years old
• first procedure during admission (\<7 days from admission).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (2)

Doncaster Royal Infirmary

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

Location

Sheffield Teaching Hospitals

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Emergencies; Malnutrition

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Timothy O'Connor, MBChB

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 6, 2021
• Study Start: January 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)