Impact of Nutritional Deficit in Emergency Surgery

Completed

• Conditions: Emergencies; Surgery; Malnutrition
• Interventions: Procedure: Emergency laparotomy

• Registration Number: NCT04696367
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

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 Timeline

• Study First Submitted: 2019-12-10
• Study Start: 2020-01-01
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with acute intra-abdominal pathology	Emergency laparotomy	Patients admitted to hospital with acute intra-abdominal pathology

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
In hospital complications	within 90 days of admission to hospital	Complications related to surgery measured using the comprehensive complication index
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
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)
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

Trial Locations

Locations (2)

Sheffield Teaching Hospitals; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

Doncaster Royal Infirmary; 🇬🇧 Doncaster, South Yorkshire, United Kingdom