Thoracic Outlet SyndromeNCT06095700
First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome
A study testing first rib resection and First rib avulsion in people with Thoracic Outlet Syndrome, run by University of Sulaimani at 1 site in Iraq.
Trial summary
The management of thoracic outlet syndrome can be either surgical or nonsurgical. Fewer than 20% of patients experience benefits from nonsurgical treatments. Regarding the surgical approach, there's considerable debate about whether to resect the first rib or if a scalenectomy alone suffices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- first rib resection and First rib avulsion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2022to 1 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: any patient diagnosed as a case of neurogenic thoracic outlet syndrome -
Exclusion Criteria: patients with other types of thoracic outlet syndrome (vascular TOS)
-
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Smart Health Tower
Sulaymaniyah, 0043
fahmi H Kakamad, PhD, +964748060, fahmi.hussein@univsul.edu.iq
Pavel M Kareem, BN, +9640915252, fahmihussein35@gmail.com
About this study
Official title: First Rib Resection Versus Avulsion for the Management of Thoracic Outlet Syndrome
The management of thoracic outlet syndrome can be either surgical or nonsurgical. Fewer than 20% of patients experience benefits from nonsurgical treatments. Regarding the surgical approach, there's considerable debate about whether to resect the first rib or if a scalenectomy alone suffices. Recently, many experts have concurred on the resection of the first rib. Based on our observations, avulsion of the first rib results in improved outcomes and reduced post-operative pain compared to simple resection. Thus, this study aims to compare the outcomes of first rib resection versus its avulsion in patients with thoracic outlet syndrome.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- first rib resection, First rib avulsion
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first rib resectionProcedure or surgery
Also called surgery
standard first rib resection
First rib avulsionProcedure or surgery
As the active treatment, just instead of resectioning the first rib, we will do an avulsion of the first rib through the same incision
| Study group | Role | What they receive |
|---|---|---|
| Rib Resection Group | Active comparator | This arm undergoes first rib resection, as mentioned in the textbook. Receives: Procedure: first rib resection |
| Rib Avulsion Group | Experimental | This group of patients undergo first rib avulsion Receives: Procedure: First rib avulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Numeric Rating Scale (NRS) is used to measure satisfaction, the patients are asked to rate their satisfaction on a scale from 0 to 10, with 0 representing "completely dissatisfied" and 10 representing "completely satisfied."
Measured: six months
post operative pain
we use the Visual Analogue Scale. A range of scores from 0-100. A higher score indicates greater pain intensity. the least value is zero and the highest value is 100
Measured: four weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahmi Hussein Kakamad, University of Sulaimani
- Investigators
- fahmi Kakamad, PhD, Study chair, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095700
- Sponsor's protocol ID
- UniSulaimani
- Status last verified
- May 2024
- First submitted
- 15 Sep 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Rib Resection Versus Avulsion for the Management of Thoracic Outlet Syndrome
- ClinicalTrials.gov ID
- NCT06095700
- Acronym / sponsor ID
- UniSulaimani
- Conditions
- Thoracic Outlet Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 23 Oct 2023 (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.
The management of thoracic outlet syndrome can be either surgical or nonsurgical. Fewer than 20% of patients experience benefits from nonsurgical treatments. Regarding the surgical approach, there's considerable debate about whether to resect the first rib or if a scalenectomy alone suffices. Recently, many experts have concurred on the resection of the first rib. Based on our observations, avulsion of the first rib results in improved outcomes and reduced post-operative pain compared to simple resection. Thus, this study aims to compare the outcomes of first rib resection versus its avulsion in patients with thoracic outlet syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rib Resection Group | Active comparator | Procedure: first rib resectionThis arm undergoes first rib resection, as mentioned in the textbook. |
| Rib Avulsion Group | Experimental | Procedure: First rib avulsionThis group of patients undergo first rib avulsion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| first rib resectionAlso: surgerystandard first rib resection | Procedure or surgery | Rib Resection Group |
| First rib avulsionAs the active treatment, just instead of resectioning the first rib, we will do an avulsion of the first rib through the same incision | Procedure or surgery | Rib Avulsion Group |
Primary outcome
patient satisfaction
Time frame: six months
Numeric Rating Scale (NRS) is used to measure satisfaction, the patients are asked to rate their satisfaction on a scale from 0 to 10, with 0 representing "completely dissatisfied" and 10 representing "completely satisfied."
post operative pain
Time frame: four weeks after the operation
we use the Visual Analogue Scale. A range of scores from 0-100. A higher score indicates greater pain intensity. the least value is zero and the highest value is 100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- 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.
fahmi Kakamad, PhD study chair
University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first rib resection and First rib avulsion in people with Thoracic Outlet Syndrome, run by University of Sulaimani at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fahmi H Kakamad, PhD (+9647717267454, fahmi.hussein@univsul.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: six months). The study lists 2 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 14 May 2024.