Clinical trial NCT04448912: Meta-Analysis on Damage Control Surgery in Patients With Non-Traumatic Abdominal Emergencies
Official title: Damage-Control Surgery in Patients With Non-traumatic Abdominal Emergencies: A Systematic Review and Meta-Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Damage Control Surgery
Non-traumatic Abdominal Emergencies
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 2170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery for non-traumatic abdominal emergencies.

Brief summary: This systematic review and meta-analysis aims to investigate the effect of damage-control surgery on mortality in patients with non-traumatic abdominal emergencies. Literature search will be conducted using PubMed. Two meta-analyses will be performed comparing (1) mortality in patients with non-trauma damage control surgery vs. non-trauma conventional surgery and (2) the observed vs. expected mortality rate in patients undergoing non-trauma damage-control surgery.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mortality
timeFrame: From hospital admission to discharge, expected to be up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospial
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Tobias Haltmeier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haltmeier T, Falke M, Quaile O, Candinas D, Schnuriger B. Damage-control surgery in patients with nontraumatic abdominal emergencies: A systematic review and meta-analysis. J Trauma Acute Care Surg. 2022 Jun 1;92(6):1075-1085. doi: 10.1097/TA.0000000000003488. Epub 2021 Dec 9.