Impact of Nutritional Deficit in Emergency Surgery

Surgery Clinical Trial

— INDIcatES  

Official title:

Impact of Nutritional Deficit in Emergency Surgery: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696367
• Other study ID #: STH20936
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: October 2021
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Malnutrition
• Surgery

Intervention

Procedure:
• Emergency laparotomy
Midline laparotomy for acute intra-abdominal pathology

Locations

Country	Name	City	State
United Kingdom	Doncaster Royal Infirmary	Doncaster	South Yorkshire
United Kingdom	Sheffield Teaching Hospitals	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	In hospital complications	Complications related to surgery measured using the comprehensive complication index	within 90 days of admission to hospital
Secondary	Feasibility of completion of complications at day of discharge	Proportion of patients with a completed comprehensive complication index	within 90 days of admission to hospital
Secondary	Change in health utility	Measured using EQ-5D-5L (EuroQol- five dimension - five level)	Measurements take at baseline, 5 days post-operatively and 90 days post-operatively
Secondary	Feasibility of completion of EQ-5D-5L (EuroQol- five dimension - five level) at 90 days	Reported as proportion of respondents replying	90 days post operatively