NCT04448912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,170

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2021

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

June 23, 2020

Last Update Submit

November 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death after surgery for non-traumatic abdominal emergencies

    From hospital admission to discharge, expected to be up to 4 weeks

Study Arms (2)

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

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

Non-trauma damge control surgery

Conventional surgery for non-traumatic abdominal emergencies

Non-trauma conventional surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery for non-traumatic abdominal emergencies.

You may qualify if:

  • 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

You may not qualify if:

  • Articles describing trauma patients exclusively
  • Articles describing pediatric patients (age below or equal to 18 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern University Hospial

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

Study Officials

  • Tobias Haltmeier, MD

    Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 26, 2020

Study Start

April 30, 2018

Primary Completion

April 24, 2021

Study Completion

April 24, 2021

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations