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Impact of Nutritional Deficit in Emergency Surgery

Impact of Nutritional Deficit in Emergency Surgery: A Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04696367
Acronym
INDIcatES
Enrollment
59
Registered
2021-01-06
Start date
2020-01-01
Completion date
2021-05-30
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies, Malnutrition, Surgery

Keywords

emergency surgery, malnutrition, pilot study

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.

Interventions

Midline laparotomy for acute intra-abdominal pathology

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time without nutrition (measured in days)within 90 days of admission to hospitalThis is defined as the time elapsed between last normal enteral intake, and resumption of enteral intake, or naso-enteric feeding, or parenteral nutrition.

Secondary

MeasureTime frameDescription
In hospital complicationswithin 90 days of admission to hospitalComplications related to surgery measured using the comprehensive complication index
Feasibility of completion of complications at day of dischargewithin 90 days of admission to hospitalProportion of patients with a completed comprehensive complication index
Change in health utilityMeasurements take at baseline, 5 days post-operatively and 90 days post-operativelyMeasured using EQ-5D-5L (EuroQol- five dimension - five level)
Feasibility of completion of EQ-5D-5L (EuroQol- five dimension - five level) at 90 days90 days post operativelyReported as proportion of respondents replying

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026