Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2500 participants
OBSERVATIONAL
2021-01-08
2022-05-01
Brief Summary
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The aim of this study is to improve care for all patients with an intestinal emergency, irrespective of whether they have surgery or not. Data will be derived from electronic patient records collected as part of routine clinical patient care on all general adult wards (excluding maternity) between 2013 and 2020. The investigators will then identify patients who had an emergency laparotomy, and those who had a laparoscopic procedure. The investigators aim to identify 2 further groups where treatment is non-surgical (but could be medical or interventional radiology) or where treatment is considered futile, suggesting that an early focus on end of life care might be appropriate. The primary objective is to provide mortality rates for different treatment options, and analysis of short- and long-term outcomes. The secondary endpoints are to define patient sub-groups with similar health characteristics based on clinical data and an established risk index and to use statistical analysis to predict the risk of death for each patient group and treatment option, which will allow the investigators to identify the best care pathways for each cluster.
Detailed Description
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AIM:
This is a single-centre retrospective cohort study utilising electronic hospital records.
STUDY DESIGN:
Data will be derived from electronic patient records collected as part of routine clinical patient care on all general adult wards (excluding maternity) between 2013 and 2020.
Inclusion criteria:
* Must have an acute intestinal condition, based on their ICD-10 codes and OPSC-4 codes
* Must be \>= 16 years of age at the time of admission
* Have at least one full set of vital signs recorded on the day of admission
* Have at least one full set of routine blood tests recorded on the day of admission
Exclusion criteria:
* Maternity admissions during/after pregnancy
* Patients admitted or undergoing abdominal surgery for a second time or more Using OPCS-4 codes from PAS and TheatreManTM and NELA data, the investigators will then identify patients who had an emergency laparotomy, and those who had a laparoscopic procedure. We aim to identify a further group where treatment is futile, suggesting that an early focus on end of life care might be appropriate.
The investigators have estimated that we will have about 2,500 patients who fulfil the inclusion criteria in this period. Patient outcomes will be analysed from up to one year following their admission for acute abdomen.
PRIMARY OBJECTIVE:
To provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.
SECONDARY OBJECTIVE:
To define patient sub-groups with similar health characteristics based on clinical data and an established risk index, and to use statistical analysis to predict the risk of death for each patient group and treatment option, which will allow us to identify the best care pathways for each cluster.
PRIMARY ENDPOINT:
The mortality risk for each treatment group
SECONDARY ENDPOINT:
The risk of other outcomes and long-term complications and association between patient factors and these outcomes
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Adult patients with acute abdominal conditions
All adult patients \>=16years of age on all general adult wards (excluding maternity) between 2013 and 2020 with the following inclusion and exclusion criteria:
Inclusion criteria:
* Must have an acute intestinal condition, based on their ICD-10 codes and OPSC-4 codes
* Must be \>= 16 years of age at the time of admission
* Have at least one full set of vital signs recorded on the day of admission
* Have at least one full set of routine blood tests recorded on the day of admission
Exclusion criteria:
* Maternity admissions during/after pregnancy
* Patients admitted or undergoing abdominal surgery for a second time or more
Laparotomy or laparoscopy
Laparotomy is the opening of the abdominal cavity usually through a midline incision.
Laparoscopy is using minimal access keyhole surgery to perform the surgery instead of laparotomy Interventional radiology is the use of imaging to perform a procedure on the abdomen without surgery, for example, using ultrasound to guide a needle to drain an abscess Best supportive care is usually end-of-life care concentration on relieving symptoms rather than treating the cause.
Interventions
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Laparotomy or laparoscopy
Laparotomy is the opening of the abdominal cavity usually through a midline incision.
Laparoscopy is using minimal access keyhole surgery to perform the surgery instead of laparotomy Interventional radiology is the use of imaging to perform a procedure on the abdomen without surgery, for example, using ultrasound to guide a needle to drain an abscess Best supportive care is usually end-of-life care concentration on relieving symptoms rather than treating the cause.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have an acute intestinal condition, based on their ICD-10 codes and OPSC-4 codes
* Must be \>= 16 years of age at the time of admission
* Have at least one full set of vital signs recorded on the day of admission
* Have at least one full set of routine blood tests recorded on the day of admission
Exclusion Criteria
* Patients admitted or undergoing abdominal surgery for a second time or more
16 Years
ALL
No
Sponsors
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University of Portsmouth
OTHER
Portsmouth Hospitals NHS Trust
OTHER_GOV
Responsible Party
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Locations
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Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Related Links
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The BCAE Study website
Other Identifiers
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PHT/2019/72
Identifier Type: -
Identifier Source: org_study_id