- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04448912
Meta-Analysis on Damage Control Surgery in Patients With Non-Traumatic Abdominal Emergencies
Damage-Control Surgery in Patients With Non-traumatic Abdominal Emergencies: A Systematic Review and Meta-Analysis
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
After the successful implementation in trauma patients, damage control surgery (DCS) is being increasingly used in patients with non-traumatic abdominal emergencies, too. However, non-trauma DCS is an ongoing matter of debate as the open abdomen treatment typically performed in DCS is a non-anatomical situation and associated with potentially severe side effects. To date, DCS in patients with non-traumatic abdominal emergencies has not yet been comprehensively assessed in meta-analysis.
A systematic literature search will be conducted using the National Library of Medicine's Medline database (PubMed). The search strategy will be based on the PICOS process. Original research articles in English language addressing (1) mortality in patients undergoing non-trauma DCS vs. non-trauma conventional surgery or (2) the observed vs. expected mortality in non-trauma DCS will be included.
Two meta-analyses will be performed, comparing (1) mortality in patients undergoing non-trauma DCS vs. non-trauma conventional surgery and (2) the observed vs. expected mortality rate in patients undergoing non-trauma DCS based on outcome prediction scores. Meta-analysis will be performed using a random-effects model. The estimated effect size for mortality will be reported as risk difference with 95% confidence intervals. Sensitivity analysis will be performed by repeating the analysis in the subgroups of studies with the same study design and studies that applied the same outcome prediction score.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Bern, Sveits, 3010
- Inselspital, Bern University Hospial
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Articles on damage control surgery in patients with non-traumatic abdominal emergencies
- Reported in-hospital or 30-day mortality in patients undergoing non-trauma damage control surgery vs non-trauma conventional surgery or
- Reported observed in-hospital or 30-day mortality vs expected mortality in patients undergoing non-trauma damage control surgery
- Articles published from 2000 to 2020
- Articles including patients older than 18 years
- Original research articles
- Articles in English language
Exclusion Criteria:
- Articles describing trauma patients exclusively
- Articles describing pediatric patients (age below or equal to 18 years)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Non-trauma damge control surgery
Patients with non-traumatic abdominal emergencies undergoing damage control surgery.
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Surgery for non-traumatic abdominal emergencies using the damage control approach
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Non-trauma conventional surgery
Patients with non-traumatic abdominal emergencies undergoing conventional surgery with primary abdominal closure.
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Conventional surgery for non-traumatic abdominal emergencies
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mortality
Tidsramme: From hospital admission to discharge, expected to be up to 4 weeks
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Death after surgery for non-traumatic abdominal emergencies
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From hospital admission to discharge, expected to be up to 4 weeks
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SRMA non-trauma DCS
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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