EmergenciesINDIcatESNCT04696367
Impact of Nutritional Deficit in Emergency Surgery
An observational study of Emergencies and Surgery, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Surgery, Malnutrition
- What is being tested?
- Emergency laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jan 2020to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending two UK hospitals which provide emergency surgery services who require an emergency laparotomy
Who may be able to join
- Willing to consent,
- -≥ 18 years old
- eligible for inclusion in National Emergency Laparotomy Audit
- first procedure during admission (<7 days from admission).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Doncaster Royal Infirmary
Doncaster, South Yorkshire, DN2 5LT
Sheffield Teaching Hospitals
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: Impact of Nutritional Deficit in Emergency Surgery: A Pilot Study
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.
Read the 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.
- Conditions
- Emergencies, Surgery, Malnutrition
- Being tested
- Emergency laparotomy
- Keywords
- emergency surgery, malnutrition, pilot study
- Medical subject headings
- Emergencies, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency laparotomyProcedure or surgery
Also called Celiotomy
Midline laparotomy for acute intra-abdominal pathology
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute intra-abdominal pathology | Patients admitted to hospital with acute intra-abdominal pathology Receives: Procedure: Emergency laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 90 days of admission to hospital
Secondary outcomes (4)
In hospital complications
Complications related to surgery measured using the comprehensive complication index
Measured: within 90 days of admission to hospital
Feasibility of completion of complications at day of discharge
Proportion of patients with a completed comprehensive complication index
Measured: within 90 days of admission to hospital
Change in health utility
Measured using EQ-5D-5L (EuroQol- five dimension - five level)
Measured: 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
Reported as proportion of respondents replying
Measured: 90 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Jan 2020
- Primary completion30 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy O'Connor, MBChB, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696367
- Sponsor's protocol ID
- STH20936
- Acronym
- INDIcatES
- Status last verified
- Oct 2021
- First submitted
- 10 Dec 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Deficit in Emergency Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT04696367
- Acronym / sponsor ID
- INDIcatES / STH20936
- Conditions
- Emergencies, Surgery, Malnutrition
- Keywords
- emergency surgery, malnutrition, pilot study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute intra-abdominal pathology | – | Procedure: Emergency laparotomyPatients admitted to hospital with acute intra-abdominal pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending two UK hospitals which provide emergency surgery services who require an emergency laparotomy
Key inclusion criteria (4 listed)
- Willing to consent,
- -≥ 18 years old
- eligible for inclusion in National Emergency Laparotomy Audit
- first procedure during admission (<7 days from admission).
Key exclusion criteria (6 listed)
- Recent discharge from hospital (within 60 days),
- unable to provide informed consent
- life expectancy <12 months
- prisoners
- lack mental capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency laparotomyAlso: CeliotomyMidline laparotomy for acute intra-abdominal pathology | Procedure or surgery | Patients with acute intra-abdominal pathology |
Primary outcome
Time without nutrition (measured in days)
Time frame: 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.
4 secondary outcomes
In hospital complications
Time frame: within 90 days of admission to hospital
Feasibility of completion of complications at day of discharge
Time frame: within 90 days of admission to hospital
Change in health utility
Time frame: 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
Time frame: 90 days post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Emergencies
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy O'Connor, MBChB principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Surgery, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time without nutrition (measured in days) (time frame: within 90 days of admission to hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.