First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome

Thoracic Outlet Syndrome Clinical Trial

Official title:

First Rib Resection Versus Avulsion for the Management of Thoracic Outlet Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095700
• Other study ID #: UniSulaimani
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: University of Sulaimani
• Contact: fahmi H Kakamad, PhD
• Phone: +9647717267454
• Email: fahmi.hussein[@]univsul.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

-

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

Intervention

Procedure:
• first rib resection
standard first rib resection
• First rib avulsion
As the active treatment, just instead of resectioning the first rib, we will do an avulsion of the first rib through the same incision

Locations

Country	Name	City	State
Iraq	Smart Health Tower	Sulaymaniyah

Sponsors (1)

Lead Sponsor	Collaborator
University of Sulaimani

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	six months
Primary	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	four weeks after the operation