- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448912
Meta-Analysis on Damage Control Surgery in Patients With Non-Traumatic Abdominal Emergencies
Damage-Control Surgery in Patients With Non-traumatic Abdominal Emergencies: A Systematic Review and Meta-Analysis
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3010
- Inselspital, Bern University Hospial
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
San Antonio Military Medical CenterUnknownOpen Abdomen After Damage Control LaparotomyUnited States
-
Instituto de Investigacion Sanitaria La FeUnknown
-
GE HealthcareCompletedEt Control Performance in Adult Population SurgeryUnited States
-
Jewish Hospital, Cincinnati, OhioCompletedPain Control Post Colorectal Surgery
-
Pusan National University Yangsan HospitalCompletedCardiac Surgery | Cardiopulmonary Bypass | Damage-associated Molecular PatternsKorea, Republic of
-
Washington University School of MedicineEnrolling by invitationSystemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to SurgeryUnited States
-
University of Roma La SapienzaCompletedComparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar SurgeryTo Control Pain After Third Molar SurgeryItaly
-
University of LjubljanaRecruitingThe Focus is to Develop a Closed-loop Control System for Anaesthesia in Vitroretinal Surgery, Surgery Due to Expansive Processes in Head, and Long-term SedationSlovenia
-
Medical University InnsbruckCompletedDamage Control for Perforated Diverticulitis
Clinical Trials on Damage control surgery
-
Fundación Pública Andaluza para la gestión de la...RecruitingAnastomotic Complication | Anastomotic Leak Small Intestine | Anastomotic Leak Large IntestineSpain
-
Medical University InnsbruckCompletedDamage Control for Perforated Diverticulitis
-
The University of Texas Health Science Center,...National Center for Advancing Translational Sciences (NCATS)CompletedOther Injury of Other Intra-abdominal Organs, Initial EncounterUnited States
-
Zimmer BiometRecruitingFractures, Bone | Fractures, Closed | Fracture | Fractures, OpenUnited States
-
Federal University of Health Science of Porto AlegreCompleted
-
Städtisches Klinikum München GmbHUniversity of Pisa; Charite University, Berlin, Germany; Medical University Innsbruck and other collaboratorsRecruitingPerforated DiverticulitisGermany
-
University Hospital Hradec KraloveRecruitingOrgan Transplant Failure or Rejection | Brain Damage Due to Hypoxia | Organ DonorsCzechia
-
Guangzhou General Hospital of Guangzhou Military...Completed
-
Duke UniversityDuke Cancer InstituteCompleted