First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 15, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedMay 14, 2024
May 1, 2024
2.4 years
September 15, 2023
May 11, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Rib Resection Group
ACTIVE COMPARATORThis arm undergoes first rib resection, as mentioned in the textbook.
Rib Avulsion Group
EXPERIMENTALThis group of patients undergo first rib avulsion
Interventions
As the active treatment, just instead of resectioning the first rib, we will do an avulsion of the first rib through the same incision
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Smart Health Tower
Sulaymaniyah, 0043, Iraq
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
fahmi Kakamad, PhD
University of Sulaimani
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Scientific Department at Smart Health Tower
Study Record Dates
First Submitted
September 15, 2023
First Posted
October 23, 2023
Study Start
January 1, 2022
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
May 14, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share