- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07148648
- Original Trial
Institutional Experience With Chest Wall Reconstruction Using Sternal Steel Wires: A Case Series Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Services Institute of Medical Sciences (SIMS), Services Hospital, Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing chest wall resection due to tumors or trauma.
Exclusion Criteria:
- Patients with contraindications to General Anesthesia.
- Patients having chest wall infection.
- Patients with pre-existing chest wall deformities or severe chronic respiratory diseases.
- Patients who undergo reoperation or develop intraoperative complications affecting the chest wall reconstruction.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Wires Group
all the participants who undergo chest wall reconstruction using sternal steel wires, number 05 are included in this group.
|
there are many methods described in literature for reconstruction of chest wall after chest wall resection.
The investigators are focusing on chest wall reconstruction using steel wires in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest Wall Recoil
Time Frame: 30 days post-operatively
|
Chest wall recoil after reconstruction is defined as maintenance of normal chest wall movement during respiration without paradoxical motion. It is assessed using spirometry (Forced Vital Capacity [FVC] and Forced Expiratory Volume in 1 second [FEV1]) compared with baseline/preoperative predicted values, radiological evaluation (postoperative chest X-rays for symmetrical expansion) and clinical observation (absence of paradoxical chest wall movement on examination). Preserving chest wall recoil is essential for normal breathing mechanics. Reconstruction with sternal steel wires aims to restore physiological elasticity, maintain ventilatory efficiency, and reduce respiratory complications. |
30 days post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Operative Pain Control
Time Frame: 24 hours, 72 hours and 07 days
|
Post-operative pain control is measured using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). It is recorded at 24 hours, 72 hours, and 7 days postoperatively. Pain is a critical determinant of recovery, respiratory function, and overall patient satisfaction. Evaluating pain scores will help determine whether sternal steel wire fixation provides a less painful and more tolerable method of chest wall reconstruction compared to alternative techniques. |
24 hours, 72 hours and 07 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Muhammad Shoaib Nabi, Professor Of Thoracic Surgery, Services Institute of Medical Sciences (SIMS), Services Hospital, Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB/2025/1653/SIMS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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