Impact of Nutritional Deficit in Emergency Surgery | NCT04696367

Studies
Impact of Nutritional Deficit in Emergency Surgery

NCT04696367

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Status

Completed

Last Update Posted

Oct 8, 2021Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Emergencies
Surgery
Malnutrition

Interventions

Emergency laparotomy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

May 30, 2021Actual

First Submitted Date

Dec 10, 2019

First Submission Date that Met QC Criteria

Jan 5, 2021

First Posted Date

Jan 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2021

Last Update Posted Date

Oct 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with acute intra-abdominal pathology		Patients admitted to hospital with acute intra-abdominal pathology	Procedure: Emergency laparotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emergency laparotomy	Procedure	Midline laparotomy for acute intra-abdominal pathology	Patients with acute intra-abdominal pathology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
In hospital complications	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy O'Connor, MBChB	Sheffield Teaching Hospitals NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Doncaster Royal Infirmary		Doncaster	South Yorkshire	DN2 5LT	United Kingdom
Sheffield Teaching Hospitals

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies
D044342	Malnutrition

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007813	Laparotomy

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided