First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Outlet Syndrome
• Intervention / Treatment: Procedure: first rib resection; Procedure: First rib avulsion

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: fahmi H Kakamad, PhD; Phone Number: +9647717267454; Email: fahmi.hussein@univsul.edu.iq
• Study Contact Backup: Name: Pavel M Kareem, BN; Phone Number: 009640915252; Email: fahmihussein35@gmail.com

Study Locations

• Iraq
  • Sulaymaniyah, Iraq, 0043
    • Recruiting
    • Smart Health Tower
    • Contact: fahmi H Kakamad, PhD; Phone Number: +964748060; Email: fahmi.hussein@univsul.edu.iq
    • Contact: Pavel M Kareem, BN; Phone Number: +9640915252; Email: fahmihussein35@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Sulaimani
• Investigators: Study Chair: fahmi Kakamad, PhD, University of Sulaimani

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Syndrome; Thoracic Outlet Syndrome
• Other Study ID Numbers: UniSulaimani

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No