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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT04448912
Collaborator
(none)
2,170
1
35.8
60.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Damage control surgery
  • Procedure: Conventional 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.

Study Design

Study Type:
Observational
Actual Enrollment :
2170 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Damage-Control Surgery in Patients With Non-traumatic Abdominal Emergencies: A Systematic Review and Meta-Analysis
Actual Study Start Date :
Apr 30, 2018
Actual Primary Completion Date :
Apr 24, 2021
Actual Study Completion Date :
Apr 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Non-trauma damge control surgery

Patients with non-traumatic abdominal emergencies undergoing damage control surgery.

Procedure: 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.

Procedure: Conventional surgery
Conventional surgery for non-traumatic abdominal emergencies

Outcome Measures

Primary Outcome Measures

  1. Mortality [From hospital admission to discharge, expected to be up to 4 weeks]

    Death after surgery for non-traumatic abdominal emergencies

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inselspital, Bern University Hospial Bern Switzerland 3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Tobias Haltmeier, MD, Inselspital, Bern University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT04448912
Other Study ID Numbers:
  • SRMA non-trauma DCS
First Posted:
Jun 26, 2020
Last Update Posted:
Apr 29, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2021