Diaphragmatic PlicationNCT04052295
Clinical and Sonographic Diaphragm Evaluation Post-plication
An observational study of Diaphragmatic Plication and Unilateral Diaphragmatic Paralysis, run by South Valley University.
Trial summary
Objectives: We aim to clarify the role of diaphragm ultrasonography (DUS) in evaluating the outcome of surgical diaphragmatic plication (SDP) in adults with symptomatic unilateral diaphragmatic paralysis (UDP). Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Diaphragmatic Plication, Unilateral Diaphragmatic Paralysis, Diaphragm Ultrasonography
- What is being tested?
- surgical diaphragmatic plication
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jan 2020
- 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 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: symptomatic unilateral diaphragmatic paralysis patients who underwent surgical diaphragmatic plication presented during a period from January 2015 to January 2020.
Who may be able to join
- Symptomatic unilateral diaphragmatic paralysis.
Who cannot join
- Children
- Morbid obesity
- Certain neuromuscular disorders
- Previous thoracic surgical intervention on the affected
- Recurrent eventration
About this study
Official title: Clinical and Sonographic Evaluation of the Diaphragm After Plication in Adults With Unilateral Eventration: a Retrospective Study
Objectives: We aim to clarify the role of diaphragm ultrasonography (DUS) in evaluating the outcome of surgical diaphragmatic plication (SDP) in adults with symptomatic unilateral diaphragmatic paralysis (UDP).
- Being tested
- surgical diaphragmatic plication
- Keywords
- Diaphragmatic eventration, Diaphragm, Dyspnea
- Medical subject headings
- Diaphragmatic Eventration, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical diaphragmatic plicationProcedure or surgery
The plication was done by the same surgeon either via a 7-8 cm long lateral thoracotomy and entrance to the pleural cavity through the eighth intercostals space on the affected side or using VATS (video-assisted thoracoscopic surgery) procedure. It was performed under single lumen intubation general anaesthesia. The diaphragm with the abdominal content was pushed caudally till the normal position of the copula achieved. At this position a fold of about 5 cm is made using traction forceps of the reluctant diaphragm. Polypropylene sutures (zero or 1) were used to perform the plication of the diaphragm. in making a fold on itself. The plication was performed using interrupted polypropylene U-stitches; usually, it started from posterior part to the anterior part of the diaphragm. We merged every two rows with continuous polypropylene sutures. The diaphragm became tough and firm and returned to its normal position. An intercostal tube was inserted, and the thoracotomy was closed in layers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
The radiological investigation included; chest sonography.
Measured: Chest sonography was done before operation; and follow up at one week and 6 months, through study completion, an average of 1 year .
Respiratory functions test for evaluation of the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %).
Measured: Spirometry was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year .
Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
The radiological investigation included; chest X-ray.
Measured: Chest X-ray was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year.
Secondary outcomes (1)
Evaluation of the efficacy of surgical diaphragmatic plication and its effect on improving patients' symptoms.
the clinical dyspnoea evaluation according to MRC score.
Measured: the data were collected preoperatively as a baseline; one week and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Jan 2015
- Primary completion1 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic PlicationStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Bary Ahmed Ibrahim, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052295
- Sponsor's protocol ID
- South Valley University 1576
- Status last verified
- May 2021
- First submitted
- 24 Jul 2019
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Sonographic Evaluation of the Diaphragm After Plication in Adults With Unilateral Eventration: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04052295
- Acronym / sponsor ID
- South Valley University 1576
- Keywords
- Diaphragmatic eventration, Diaphragm, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 9 Aug 2019 (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.
Objectives: We aim to clarify the role of diaphragm ultrasonography (DUS) in evaluating the outcome of surgical diaphragmatic plication (SDP) in adults with symptomatic unilateral diaphragmatic paralysis (UDP).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- symptomatic unilateral diaphragmatic paralysis patients who underwent surgical diaphragmatic plication presented during a period from January 2015 to January 2020.
Key inclusion criteria (1 listed)
- Symptomatic unilateral diaphragmatic paralysis.
Key exclusion criteria (5 listed)
- Children
- Morbid obesity
- Certain neuromuscular disorders
- Previous thoracic surgical intervention on the affected
- Recurrent eventration
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 |
|---|---|---|
| surgical diaphragmatic plicationThe plication was done by the same surgeon either via a 7-8 cm long lateral thoracotomy and entrance to the pleural cavity through the eighth intercostals space on the affected side or using VATS (video-assisted thoracoscopic surgery) procedure. It was performed under single lumen intubation general anaesthesia. The diaphragm with the abdominal content was pushed caudally till the normal position of the copula achieved. At this position a fold of about 5 cm is made using traction forceps of the reluctant diaphragm. Polypropylene sutures (zero or 1) were used to perform the plication of the diaphragm. in making a fold on itself. The plication was performed using interrupted polypropylene U-stitches; usually, it started from posterior part to the anterior part of the diaphragm. We merged every two rows with continuous polypropylene sutures. The diaphragm became tough and firm and returned to its normal position. An intercostal tube was inserted, and the thoracotomy was closed in layers. | Procedure or surgery | – |
Primary outcome
Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
Time frame: Chest sonography was done before operation; and follow up at one week and 6 months, through study completion, an average of 1 year .
The radiological investigation included; chest sonography.
Respiratory functions test for evaluation of the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
Time frame: Spirometry was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year .
Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %).
Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
Time frame: Chest X-ray was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year.
The radiological investigation included; chest X-ray.
1 secondary outcome
Evaluation of the efficacy of surgical diaphragmatic plication and its effect on improving patients' symptoms.
Time frame: the data were collected preoperatively as a baseline; one week and 6 months postoperatively.
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 11 May 2021.
- Individual participant dataSharing planned: No
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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 Diaphragmatic Plication and Unilateral Diaphragmatic Paralysis, run by South Valley 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 5 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 11 May 2021. 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?
Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis. (time frame: Chest sonography was done before operation; and follow up at one week and 6 months, through study completion, an average of 1 year .). The study lists 3 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 11 May 2021.