Damage Control SurgeryNCT04448912
Meta-Analysis on Damage Control Surgery in Patients With Non-Traumatic Abdominal Emergencies
An observational study of Damage Control Surgery and Non-traumatic Abdominal Emergencies, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Damage Control Surgery, Non-traumatic Abdominal Emergencies
- What is being tested?
- Conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,170 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2018to 24 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery for non-traumatic abdominal emergencies.
Who may be able to join
- 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
Who cannot join
- Articles describing trauma patients exclusively
- Articles describing pediatric patients (age below or equal to 18 years)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Damage control surgery, Conventional surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damage control surgeryProcedure or surgery
Surgery for non-traumatic abdominal emergencies using the damage control approach
Conventional surgeryProcedure or surgery
Conventional surgery for non-traumatic abdominal emergencies
| Study group | Role | What they receive |
|---|---|---|
| Non-trauma damge control surgery | Patients with non-traumatic abdominal emergencies undergoing damage control surgery. Receives: Procedure: Damage control surgery | |
| Non-trauma conventional surgery | Patients with non-traumatic abdominal emergencies undergoing conventional surgery with primary abdominal closure. Receives: Procedure: Conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death after surgery for non-traumatic abdominal emergencies
Measured: From hospital admission to discharge, expected to be up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start30 Apr 2018
- Primary completion24 Apr 2021
- Study completion24 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Damage Control SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Haltmeier, MD, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448912
- Sponsor's protocol ID
- SRMA non-trauma DCS
- Status last verified
- Nov 2024
- First submitted
- 23 Jun 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34882591
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Damage-Control Surgery in Patients With Non-traumatic Abdominal Emergencies: A Systematic Review and Meta-Analysis
- ClinicalTrials.gov ID
- NCT04448912
- Acronym / sponsor ID
- SRMA non-trauma DCS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,170 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 24 Apr 2021 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-trauma damge control surgery | – | Procedure: Damage control surgeryPatients with non-traumatic abdominal emergencies undergoing damage control surgery. |
| Non-trauma conventional surgery | – | Procedure: Conventional surgeryPatients with non-traumatic abdominal emergencies undergoing conventional surgery with primary abdominal closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for non-traumatic abdominal emergencies.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Articles describing trauma patients exclusively
- Articles describing pediatric patients (age below or equal to 18 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Damage control surgerySurgery for non-traumatic abdominal emergencies using the damage control approach | Procedure or surgery | Non-trauma damge control surgery |
| Conventional surgeryConventional surgery for non-traumatic abdominal emergencies | Procedure or surgery | Non-trauma conventional surgery |
Primary outcome
Mortality
Time frame: From hospital admission to discharge, expected to be up to 4 weeks
Death after surgery for non-traumatic abdominal emergencies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Derived from this study: PubMed 34882591Haltmeier 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.
- Individual participant dataSharing planned: No
Related trials for Damage Control Surgery
Not yet recruitingObservational study
Clinical Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma
Abdominal Trauma, Damage Control Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Haltmeier, MD principal investigator
Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Damage Control Surgery and Non-traumatic Abdominal Emergencies, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From hospital admission to discharge, expected to be up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.