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

April 26, 2021 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

2170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bern, Switzerland, 3010
        • Inselspital, Bern University Hospial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgery for non-traumatic abdominal emergencies.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-trauma damge control surgery
Patients with non-traumatic abdominal emergencies undergoing damage control surgery.
Surgery for non-traumatic abdominal emergencies using the damage control approach
Non-trauma conventional surgery
Patients with non-traumatic abdominal emergencies undergoing conventional surgery with primary abdominal closure.
Conventional surgery for non-traumatic abdominal emergencies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From hospital admission to discharge, expected to be up to 4 weeks
Death after surgery for non-traumatic abdominal emergencies
From hospital admission to discharge, expected to be up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2018

Primary Completion (Actual)

April 24, 2021

Study Completion (Actual)

April 24, 2021

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRMA non-trauma DCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Damage Control Surgery

Clinical Trials on Damage control surgery

3
Subscribe