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NCT Number: NCT04448912

Meta-Analysis on Damage Control Surgery in Patients With Non-Traumatic Abdominal Emergencies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Bern University Hospial

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Damage control surgery

Procedure

Surgery for non-traumatic abdominal emergencies using the damage control approach

conventional surgery

Procedure

Conventional surgery for non-traumatic abdominal emergencies

Primary outcomes

  1. Mortality

    Time frame: From hospital admission to discharge, expected to be up to 4 weeks

    Death after surgery for non-traumatic abdominal emergencies

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Damage-Control Surgery in Patients With Non-traumatic Abdominal Emergencies: A Systematic Review and Meta-Analysis

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 26, 2020
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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