Clinical trial NCT04710602: Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma
Official title: A Prospective Follow-up of Patients Treated With Muscle Sparing, Minimally Invasive Open Surgical Technique for Unstable Chest Wall After Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rib; Fracture, Multiple, With Flail Chest
Keywords: Chest wall
Trauma
Minimally invasive
Surgery
Muscle sparing
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients surgically treated at our trauma ward for unstable chest wall due to trauma. Consecutive sampling.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vital capacity of the lungs.
timeFrame: One year after surgery.
measure: Forced vital capacity of the lungs.
timeFrame: One year after surgery.
measure: Forced expiratory volume of the lungs.
timeFrame: One year after surgery.
measure: Forced expiratory volume percent of the lungs.
timeFrame: One year after surgery.
measure: Peak expiratory flow of the lungs.
timeFrame: One year after surgery.
Secondary outcomes:
measure: Disability
timeFrame: Six months and one year after surgery.
measure: Physical activity
timeFrame: Six months and one year after surgery.
measure: Shoulder mobility
timeFrame: Six months and one year after surgery.
measure: Respiratory movement
timeFrame: Six months and one year after surgery.
measure: Strength of respiratory muscles
timeFrame: Six months and one year after surgery.
measure: Quality of life EQ-5D-5L
timeFrame: Six months and one year after surgery.
measure: Radiological healing
timeFrame: One year after surgery.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Erik Westin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bemelman M, van Baal M, Yuan JZ, Leenen L. The Role of Minimally Invasive Plate Osteosynthesis in Rib Fixation: A Review. Korean J Thorac Cardiovasc Surg. 2016 Feb;49(1):1-8. doi: 10.5090/kjtcs.2016.49.1.1. Epub 2016 Feb 5.
citation: Caragounis EC, Fagevik Olsen M, Pazooki D, Granhed H. Surgical treatment of multiple rib fractures and flail chest in trauma: a one-year follow-up study. World J Emerg Surg. 2016 Jun 14;11:27. doi: 10.1186/s13017-016-0085-2. eCollection 2016.
citation: Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.
citation: Granhed HP, Pazooki D. A feasibility study of 60 consecutive patients operated for unstable thoracic cage. J Trauma Manag Outcomes. 2014 Dec 30;8(1):20. doi: 10.1186/s13032-014-0020-z. eCollection 2014.
citation: Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013 May;216(5):924-32. doi: 10.1016/j.jamcollsurg.2012.12.024. Epub 2013 Feb 13.
citation: Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.