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First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome

Primary Purpose

Thoracic Outlet Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Iraq

Study Type

Interventional

Intervention

first rib resection

First rib avulsion

About this trial

This is an interventional treatment trial for Thoracic Outlet Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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) -

Sites / Locations

Smart Health TowerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rib Resection Group

Rib Avulsion Group

Arm Description

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

This group of patients undergo first rib avulsion

Outcomes

Primary Outcome Measures

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."

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

Secondary Outcome Measures

Full Information

NCT ID

NCT06095700

First Posted

September 15, 2023

Last Updated

October 17, 2023

Sponsor

University of Sulaimani

1. Study Identification

Unique Protocol Identification Number

NCT06095700

Brief Title

First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sulaimani

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracic Outlet Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rib Resection Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Rib Avulsion Group

Arm Type

Experimental

Arm Description

This group of patients undergo first rib avulsion

Intervention Type

Procedure

Intervention Name(s)

first rib resection

Other Intervention Name(s)

surgery

Intervention Description

standard first rib resection

Intervention Type

Procedure

Intervention Name(s)

First rib avulsion

Intervention Description

As the active treatment, just instead of resectioning the first rib, we will do an avulsion of the first rib through the same incision

Primary Outcome Measure Information:

Title

patient satisfaction

Description

Time Frame

six months

Title

post operative pain

Description

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

Time Frame

four weeks after the operation

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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) -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

fahmi H Kakamad, PhD

Phone

+9647717267454

fahmi.hussein@univsul.edu.iq

First Name & Middle Initial & Last Name or Official Title & Degree

Pavel M Kareem, BN

Phone

009640915252

fahmihussein35@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

fahmi Kakamad, PhD

Organizational Affiliation

University of Sulaimani

Official's Role

Study Chair

Facility Information:

Facility Name

Smart Health Tower

City

Sulaymaniyah

ZIP/Postal Code

0043

Country

Iraq

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

fahmi H Kakamad, PhD

Phone

+964748060

fahmi.hussein@univsul.edu.iq

First Name & Middle Initial & Last Name & Degree

Pavel M Kareem, BN

Phone

+9640915252

fahmihussein35@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome

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