First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome

Sponsor

University of Sulaimani (Other)

Overall Status

Recruiting

CT.gov ID

NCT06095700

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Outlet Syndrome	Procedure: first rib resection Procedure: First rib avulsion	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rib Resection Group This arm undergoes first rib resection, as mentioned in the textbook.	Procedure: first rib resection standard first rib resection Other Names: surgery
Experimental: Rib Avulsion Group This group of patients undergo first rib avulsion	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: Rib Resection Group

This arm undergoes first rib resection, as mentioned in the textbook.

Procedure: first rib resection

standard first rib resection

Other Names:

surgery

Experimental: Rib Avulsion Group

This group of patients undergo first rib avulsion

Procedure: 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

Outcome Measures

Primary Outcome Measures

patient satisfaction [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Smart Health Tower	Sulaymaniyah		Iraq	0043

Sponsors and Collaborators

University of Sulaimani

Investigators

Study Chair: fahmi Kakamad, PhD, University of Sulaimani

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fahmi Hussein Kakamad, Director of Scientific Department at Smart Health Tower, University of Sulaimani

ClinicalTrials.gov Identifier:

NCT06095700

Other Study ID Numbers:

UniSulaimani

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thoracic Outlet Syndrome

Syndrome

Study Results

No Results Posted as of Oct 23, 2023