Meta-Analysis on Damage Control Surgery in Patients With... | NCT04448912

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

NCT04448912

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Nov 14, 2024Actual

Enrollment

2,170Actual

Phase

Not provided

Conditions

Damage Control Surgery
Non-traumatic Abdominal Emergencies

Interventions

Damage control surgery
Conventional surgery

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2018Actual

Primary Completion Date

Apr 24, 2021Actual

Completion Date

Apr 24, 2021Actual

First Submitted Date

Jun 23, 2020

First Submission Date that Met QC Criteria

Jun 23, 2020

First Posted Date

Jun 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2024

Last Update Posted Date

Nov 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-trauma damge control surgery		Patients with non-traumatic abdominal emergencies undergoing damage control surgery.	Procedure: Damage control surgery
Non-trauma conventional surgery		Patients with non-traumatic abdominal emergencies undergoing conventional surgery with primary abdominal closure.	Procedure: Conventional surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Damage control surgery	Procedure	Surgery for non-traumatic abdominal emergencies using the damage control approach	Non-trauma damge control surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing surgery for non-traumatic abdominal emergencies.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tobias Haltmeier, MD	Inselspital, Bern University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inselspital, Bern University Hospial		Bern		3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34882591	Derived	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.