Hernia, DiaphragmaticNCT05591482
Postoperative Outcomes of Trans-abdominal Open Surgical Repair of Traumatic Diaphragmatic Hernias in Adults.
An observational study of Hernia, Diaphragmatic, run by Zagazig University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Diaphragmatic
- What is being tested?
- mesh repair
- Type of treatment
- Surgery or procedure
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jun 2022
- 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
- Adult, Older adult
Study population: Between January 2014 and January 2019, 185 patients with acute and chronic traumatic diaphragmatic hernia underwent a retrospective observational study at the general surgery department of Zagazig University. Patients who were >18 years old, male or female, and had an acute or chronic traumatic diaphragmatic hernia met the inclusion 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 were all excluded from the study.
Who may be able to join
- >18 years old, male or female, and had an acute or chronic traumatic diaphragmatic hernia
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Hernia, Diaphragmatic
- Being tested
- mesh repair
- Medical subject headings
- Hernia, Diaphragmatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesh repairProcedure or surgery
mesh repair of diaphragmatic hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent hernia
recurrence of diaphragmatic hernia after repair
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Jan 2014
- Primary completion1 Jan 2019
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, DiaphragmaticStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591482
- Sponsor's protocol ID
- zagazig 15
- Status last verified
- Oct 2022
- First submitted
- 16 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes of Trans-abdominal Open Surgical Repair of Traumatic Diaphragmatic Hernias in Adults.
- ClinicalTrials.gov ID
- NCT05591482
- Acronym / sponsor ID
- zagazig 15
- Conditions
- Hernia, Diaphragmatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Oct 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Between January 2014 and January 2019, 185 patients with acute and chronic traumatic diaphragmatic hernia underwent a retrospective observational study at the general surgery department of Zagazig University. Patients who were >18 years old, male or female, and had an acute or chronic traumatic diaphragmatic hernia met the inclusion 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 were all excluded from the study.
Key inclusion criteria (1 listed)
- >18 years old, male or female, and had an acute or chronic traumatic diaphragmatic hernia
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| mesh repairmesh repair of diaphragmatic hernia | Procedure or surgery | – |
Primary outcome
recurrent hernia
Time frame: 3.5 years
recurrence of diaphragmatic hernia after repair
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 24 Oct 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Diaphragmatic, run by Zagazig University.
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 1 inclusion and 1 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 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
recurrent hernia (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2022.