Diaphragmatic EventrationNCT07035366
Two Procedures for Uniportal Video Assisted Thoracoscopic Surgery to Treat Severe Cases of Diaphragmatic Eventration in Adult
A study testing stabled resection and running sutures in people with Diaphragmatic Eventration, run by Zagazig University at 3 sites in Egypt.
Trial summary
highly elevated abnormal diaphragm is lowered to normal position by runuing suture accordion shaped or cut part of diphragm by stabler Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diaphragmatic Eventration
- What is being tested?
- stabled resection and running sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesEgypt
- Study dates
- 15 Jan 2023to 15 Mar 2025
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who presented with dyspnea or orthopnea with sever eventration
Who cannot join
- other causes of dyspnea or elevated hemidiaphragm
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
Zagazig, Sharqia Province, 44519
cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt
Zagazig, Sharqia Province, 44519
Cardiothoracic Surgery Department-Faculty of Mdecine-Zagazig Univeristy
Zagazig, Sharqia Province
About this study
highly elevated abnormal diaphragm is lowered to normal position by runuing suture accordion shaped or cut part of diphragm by stabler
Read the detailed description
high degree of eventration is corrected either stabled resection or running sutures
- Conditions
- Diaphragmatic Eventration
- Being tested
- stabled resection, running sutures
- Keywords
- stabled resection, running sutures, diaphragmatic eventration
- Medical subject headings
- Diaphragmatic Eventration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stabled resectionProcedure or surgery
diaphragmatic plication of sever eventration by stabled resection
running suturesProcedure or surgery
plication of diaphragmatic eventration by running sutures
| Study group | Role | What they receive |
|---|---|---|
| running sutures | Experimental | diaphragmatic plication by running sutures Receives: Procedure: running sutures |
| stabled resection | Experimental | diaphragmatic plication by stabled resection Receives: Procedure: stabled resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic & Recovery Time (days)
Measured: 1 week after surgery
operative time (min)
Measured: from the start of skin incision till the extubation of the patient
postoperative pain(pain score)
Measured: postoperative pain recieved by operated patient
lung function recovery (lung function test)
forced expiratory volume in 1st second,
Measured: lung function test done one and three months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 Jan 2023
- Primary completion10 Dec 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic EventrationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Mohamed Osman, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035366
- Sponsor's protocol ID
- ZU-IRB # 738/15-oct-2024
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Procedures for Uniportal Video Assisted Thoracoscopic Surgery to Treat Severe Cases of Diaphragmatic Eventration in Adult
- ClinicalTrials.gov ID
- NCT07035366
- Acronym / sponsor ID
- ZU-IRB # 738/15-oct-2024
- Conditions
- Diaphragmatic Eventration
- Keywords
- stabled resection, running sutures, diaphragmatic eventration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 25 Jun 2025 (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.
highly elevated abnormal diaphragm is lowered to normal position by runuing suture accordion shaped or cut part of diphragm by stabler
Detailed description
high degree of eventration is corrected either stabled resection or running sutures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| running sutures | Experimental | Procedure: running suturesdiaphragmatic plication by running sutures |
| stabled resection | Experimental | Procedure: stabled resectiondiaphragmatic plication by stabled resection |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who presented with dyspnea or orthopnea with sever eventration
Key exclusion criteria (1 listed)
- other causes of dyspnea or elevated hemidiaphragm
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 |
|---|---|---|
| stabled resectiondiaphragmatic plication of sever eventration by stabled resection | Procedure or surgery | stabled resection |
| running suturesplication of diaphragmatic eventration by running sutures | Procedure or surgery | running sutures |
Primary outcome
Cosmetic & Recovery Time (days)
Time frame: 1 week after surgery
operative time (min)
Time frame: from the start of skin incision till the extubation of the patient
postoperative pain(pain score)
Time frame: postoperative pain recieved by operated patient
lung function recovery (lung function test)
Time frame: lung function test done one and three months postoperative
forced expiratory volume in 1st second,
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 25 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Diaphragmatic Eventration
RecruitingObservational study
An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels
Gastroschisis, Congenital Diaphragmatic Hernia
Not yet recruitingObservational study
Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis
Diaphragmatic Plication, Diaphragmatic Paralysis
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stabled resection and running sutures in people with Diaphragmatic Eventration, run by Zagazig University at 3 sites in Egypt.
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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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?
Cosmetic & Recovery Time (days) (time frame: 1 week after surgery). The study lists 4 primary outcomes in all. 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 25 Jun 2025.