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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05591482
Other study ID # zagazig 15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date June 1, 2022

Study information

Verified date October 2022
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 185
Est. completion date June 1, 2022
Est. primary completion date January 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
mesh repair
mesh repair of diaphragmatic hernia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Outcome

Type Measure Description Time frame Safety issue
Primary recurrent hernia recurrence of diaphragmatic hernia after repair 3.5 years
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