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

Damage Control Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448912
• Other study ID #: SRMA non-trauma DCS
• Status: Completed
• Start date: April 30, 2018
• Est. completion date: April 24, 2021

Study information

• Verified date: April 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2170
• Est. completion date: April 24, 2021
• Est. primary completion date: April 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Damage Control Surgery
• Emergencies
• Non-traumatic Abdominal Emergencies

Intervention

Procedure:
• Damage control surgery
Surgery for non-traumatic abdominal emergencies using the damage control approach
• Conventional surgery
Conventional surgery for non-traumatic abdominal emergencies

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospial	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death after surgery for non-traumatic abdominal emergencies	From hospital admission to discharge, expected to be up to 4 weeks