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Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma

S

Sahlgrenska University Hospital

Status

Completed

Conditions

Rib; Fracture, Multiple, With Flail Chest

Treatments

Procedure: Large incision surgical fixation of unstable rib cage.
Procedure: Minimally invasive surgical fixation of unstable rib cage

Study type

Observational

Funder types

Other

Identifiers

NCT04710602
FoU-274457

Details and patient eligibility

About

The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.

Full description

This is a prospective follow-up study where the investigators aim to study patients who have undergone surgery with a muscle sparing, minimally invasive technique for unstable ribcage after trauma. The investigators plan on seeing the participants as out patients 6 months and 1 year after surgery. The results will be compared to results from a historical cohort with patients who participated in earlier studies with a different surgical method with large incisions and simultaneous thoracotomy. The investigators plan on including 50 patients since a preliminary analysis has suggested this should be enough to notice statistically significant differences between the groups.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with chest wall trauma who underwent surgical stabilisation for unstable chest wall using a minimally invasive, muscle sparing technique without thoracotomy or thoracoscopy no more than 6 months prior to inclusion.

Exclusion criteria

  • Severe head injury (Abbreviated Injury score (AIS) >3)
  • Spinal injury
  • Neurological or musculoskeletal disease affecting chest wall mobility

Trial design

100 participants in 2 patient groups

Minimally invasive
Description:
Patients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma.
Treatment:
Procedure: Minimally invasive surgical fixation of unstable rib cage
Historical control
Description:
Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma.
Treatment:
Procedure: Large incision surgical fixation of unstable rib cage.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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