First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome

NCT ID: NCT06095700

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Outlet Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Rib Resection Group

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

Group Type ACTIVE_COMPARATOR

first rib resection

Intervention Type PROCEDURE

standard first rib resection

Rib Avulsion Group

This group of patients undergo first rib avulsion

Group Type EXPERIMENTAL

First rib avulsion

Intervention Type PROCEDURE

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

Interventions

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first rib resection

standard first rib resection

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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surgery

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sulaimani

OTHER

Sponsor Role lead

Responsible Party

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Fahmi Hussein Kakamad

Director of Scientific Department at Smart Health Tower

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fahmi Kakamad, PhD

Role: STUDY_CHAIR

University of Sulaimani

Locations

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Smart Health Tower

Sulaymaniyah, , Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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fahmi H Kakamad, PhD

Role: CONTACT

+9647717267454

Pavel M Kareem, BN

Role: CONTACT

009640915252

Facility Contacts

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fahmi H Kakamad, PhD

Role: primary

+964748060

Pavel M Kareem, BN

Role: backup

+9640915252

Other Identifiers

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UniSulaimani

Identifier Type: -

Identifier Source: org_study_id

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