- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05591482
Postoperative Outcomes of Trans-abdominal Open Surgical Repair of Traumatic Diaphragmatic Hernias in Adults.
Objective: Evaluation of our management of acute or chronic traumatic diaphragmatic hernia repair with sutures or mesh.
Between January 2014 and January 2019, a retrospective study on 185 patients with acute and chronic traumatic diaphragmatic hernias was carried out at the general surgery department of Zagazig University. Results both during and after surgery were assessed.
Study Overview
Detailed Description
Traumatic diaphragmatic hernias are the outcome of 0.8% to 6% of blunt trauma cases and more than 17% of cases involving thoraco-abdominal-penetrating trauma (TDH) . Chronic traumatic diaphragmatic herniation (CTDH) is a condition that can develop as a result of an enlargement of a defect in the diaphragm brought on by a pressure difference between the thoracic cavity and the abdominal cavity . It is possible that the rupture will not heal on its own due to the inherent pressure difference that exists between the thorax and the abdomen as well as the continuous movement of the diaphragm .
Due to the seriousness of the related organs' injuries, traumatic diaphragmatic rupture presents a complex emergency and typically necessitates a high diagnostic suspicion. The herniated structures may strangulate into the thoracic cavity, and the mortality rate may increase considerably if the traumatic diaphragmatic hernia is not identified and treated in the acute phase of the trauma . These patients may not be diagnosed until weeks, months, or even years after the initial traumatic event, and they may present with acute symptoms related to the cardiovascular system and the digestive tract. A high mortality rate is seen in people with CTDH with viscera that have been strangulated.
Despite advancements in diagnostic technologies, 2.7 - 50% of patients still have a misdiagnosis . Early, accurate diagnosis is now more common thanks to greater experience and the emergence of imaging tools, particularly computed tomography (CT).
A limited number of researches describe acute and chronic traumatic diaphragmatic hernias in terms of intraoperative and postoperative outcomes. To examine the intraoperative and postoperative results of patients with traumatic diaphragmatic hernias repaired using either suture repair or mesh repair in terms of morbidity, mortality rate, and incidence of recurrence, the investigators have established a retrospective cohort analysis for the current investigation.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- >18 years old, male or female, and had an acute or chronic traumatic diaphragmatic hernia
Exclusion Criteria:
- Hiatus hernias, congenital hernias, diaphragmatic tears without herniation of abdominal organs, eventration of the diaphragm, hernias on both sides of the diaphragm, and recurrent diaphragmatic hernia after prior repair
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrent hernia
Time Frame: 3.5 years
|
recurrence of diaphragmatic hernia after repair
|
3.5 years
|
Collaborators and Investigators
Sponsor
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
- zagazig 15
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.
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